Overview #
When brand partners ship consumer packaging into the EU, UK, or California markets, REACH and RoHS compliance is not optional paperwork — it is a gate that determines whether your product clears customs and stays on shelf. The core challenge is that packaging materials — inks, coatings, adhesives, foils, and substrates — can each carry restricted substances, and a single non-conforming component can trigger a full product recall. We manage this across every material input in our supply chain, from the greyboard we specify at 1.8–2.5mm for rigid boxes to the UV-cure inks we run at 180–220 mJ/cm² on our offset lines. This guide explains how we structure SVoC testing, what supplier declaration data we collect, and what documentation we provide to brand partners for their compliance files.
REACH & RoHS: What the Regulations Actually Require from Packaging #
REACH (EC No 1907/2006) restricts Substances of Very High Concern (SVHCs) on the Candidate List — currently over 240 substances — at a threshold of 0.1% w/w in any article. For packaging, the most commonly triggered SVHCs are phthalates (DEHP, DBP, BBP, DIBP), heavy metals in pigments (lead, cadmium, hexavalent chromium), and certain flame retardants used in foam inserts or EPS components.
RoHS Directive 2011/65/EU (recast) restricts 10 substances in electrical and electronic equipment, but its scope extends to packaging supplied with EEE products — meaning if your packaging ships with a consumer electronics device, RoHS substance limits apply to the packaging itself. The key thresholds are: lead ≤ 1,000 ppm, mercury ≤ 1,000 ppm, cadmium ≤ 100 ppm, hexavalent chromium ≤ 1,000 ppm, and four phthalates (DEHP, BBP, DBP, DIBP) each ≤ 1,000 ppm.
For food-contact packaging, EU Regulation 10/2011 on plastic materials adds migration limits — total migration ≤ 10 mg/dm² and specific migration limits (SMLs) per substance — which we treat as a parallel compliance layer alongside REACH.
| Regulation | Scope | Key Threshold | Packaging Trigger |
|---|---|---|---|
| REACH EC 1907/2006 | SVHCs in articles | 0.1% w/w per substance | All packaging articles sold into EU/UK |
| RoHS 2011/65/EU | 10 restricted substances | Pb/Hg/Cr⁶⁺ ≤ 1,000 ppm; Cd ≤ 100 ppm | Packaging supplied with EEE products |
| EU 10/2011 | Plastic food-contact materials | Total migration ≤ 10 mg/dm² | Food-contact flexible and rigid packaging |
| California Prop 65 | 900+ listed chemicals | NSRL/MADL thresholds vary | Consumer packaging sold in California |
| GB/T 26572-2011 | RoHS equivalent for China market | Same 6 substance limits as EU RoHS | Packaging for China domestic EEE market |
SVoC Testing Protocols: How We Test and What We Accept #
SVoC (Semi-Volatile Organic Compound) testing for packaging compliance focuses on phthalates, polycyclic aromatic hydrocarbons (PAHs), and bisphenols — all of which can be present in plasticised coatings, recycled-content substrates, or adhesive systems.
Our standard test protocol for a new material or ink system follows IEC 62321 (for RoHS substance determination) and EN ISO 17294-2 for heavy metals by ICP-MS. For phthalate screening, we use GC-MS per EPA Method 8270D, with a reporting limit of 10 ppm per analyte. Any result above 500 ppm for a single phthalate triggers a hold and supplier escalation before the material enters production.
For UV-cure ink systems — which we run on both sheet-fed offset and digital inkjet lines — we require photoinitiator migration testing per EN 15338 for food-adjacent packaging. Unreacted photoinitiators are a known SVHC risk in UV inks; we specify a maximum residual photoinitiator level of 0.5 mg/kg in the cured ink film for any packaging that contacts or is adjacent to food products.
On our production floor, we maintain a Restricted Substance List (RSL) that maps every approved ink, coating, adhesive, and substrate to its test data. No new material enters our approved supplier list without a full test report from a CNAS- or ILAC-accredited laboratory. We re-test annually and after any supplier formulation change notification.
Supplier Declaration Management: The Data We Collect and How We Verify It #
A supplier declaration (SD) or Declaration of Conformity (DoC) is only as reliable as the test data behind it. We require three tiers of documentation from every material supplier:
Tier 1 — Declaration of Conformity: Signed statement confirming compliance with REACH SVHC Candidate List (current version), RoHS 2011/65/EU Annex II, and where applicable EU 10/2011. Must reference the specific regulation version and declaration date. We reject undated or version-unspecified declarations.
Tier 2 — Full Material Disclosure (FMD): Component-level substance data to 0.01% w/w, submitted in IPC-1752A Class D format or equivalent. This is mandatory for all inks, coatings, and adhesives. For substrates, we require FSC chain-of-custody certification (FSC-STD-40-004) plus a heavy metals declaration covering the 4 EU Packaging Directive restricted metals (Pb, Cd, Hg, Cr⁶⁺) at the combined threshold of 100 ppm per EU Directive 94/62/EC.
Tier 3 — Third-Party Test Reports: Accredited lab reports, not older than 24 months, covering the substance groups relevant to the material type. For pigment-containing inks, this means ICP-MS heavy metals data. For adhesives and coatings, this means phthalate and bisphenol screening. We cross-reference Tier 3 data against Tier 1 declarations — any discrepancy triggers a supplier audit.
Our incoming QC team logs all supplier documentation in our compliance management system with expiry tracking. When a declaration expires or a new SVHC is added to the Candidate List, our system flags the affected materials within 5 working days and initiates a re-declaration request.
Specification Notes for Brand Partners #
When you brief us on a packaging project requiring REACH or RoHS compliance documentation, the first thing we need to know is the destination market and end-product category — EU general consumer goods, EEE packaging, food-contact, or California retail each trigger different test requirements and documentation formats. A common mistake we see is brands requesting “REACH compliance” without specifying whether they need full SVHC Candidate List coverage or only the 10 RoHS substances — these are different documents and different test scopes.
For a standard compliance package, our process runs as follows: material verification and supplier declaration collection takes 5–7 working days for approved materials already on our RSL. If a new ink colour or substrate is required, add 10–15 working days for third-party testing. We issue a project-level Declaration of Conformity, a full material disclosure summary, and copies of all supporting third-party test reports. For food-contact packaging, we also provide EU 10/2011 migration test data. Physical samples with compliance documentation are typically ready within 15–20 working days from brief confirmation.
Frequently Asked Questions #
Q1: What is the REACH SVHC threshold that applies to our packaging, and how do you test for it?
A: The REACH threshold is 0.1% w/w (1,000 ppm) per SVHC substance in any single article. We test using ICP-MS per EN ISO 17294-2 for heavy metals and GC-MS per EPA Method 8270D for phthalates, with a reporting limit of 10 ppm — well below the regulatory threshold — so we catch issues before they reach your compliance file.
Q2: What is your lead time for providing a full REACH and RoHS compliance documentation package?
A: For packaging using materials already on our approved supplier list, we can compile and issue a full compliance package — Declaration of Conformity, FMD summary, and third-party test reports — within 5–7 working days. If new materials require third-party testing, allow 10–15 additional working days for accredited lab turnaround.
Q3: Does RoHS apply to our packaging if we are not selling electronics?
A: RoHS 2011/65/EU applies to packaging when it is supplied together with electrical or electronic equipment. If your product is non-EEE, REACH is the primary regulation. However, we recommend running RoHS-compliant materials across all product lines regardless, since the cadmium limit of 100 ppm and the combined heavy metals limit of 100 ppm under EU Directive 94/62/EC apply to all packaging in the EU market.
Q4: Can you provide food-contact compliance documentation for printed flexible packaging?
A: Yes. For food-contact flexible packaging, we provide EU Regulation 10/2011 migration test data alongside REACH documentation. Our UV-cure ink systems are tested to a maximum residual photoinitiator level of 0.5 mg/kg in the cured film, and we require total migration results at ≤ 10 mg/dm² before approving any food-contact substrate-ink combination for production.
Q5: What happens if a new SVHC is added to the REACH Candidate List after our packaging is already in production?
A: Our compliance management system flags affected materials within 5 working days of a Candidate List update. We then initiate re-declaration requests from relevant suppliers and, if the new SVHC is present above 0.1% w/w in any article component, we notify you immediately and propose a compliant material substitution. We do not wait for your next order cycle to surface this — proactive notification is part of our standard compliance service.
Planning a packaging project that requires REACH, RoHS, or food-contact compliance documentation? Contact our team to request a complimentary specification review and sample quote.
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