Quick answer: REACH authorisation risk on cases sits almost entirely in colourants: azo pigments, phthalate carriers, lead chromate and cadmium yellows.

Table of contents

  • Why the colourant comes first
  • Four groups and the limits that apply
  • Annex XIV and Annex XVII do different jobs
  • The 0.1% test runs per worst-case part
  • Article 33 and SCIP in practice
  • FAQ

1. Why the colourant comes first

A 5.8 kg graphite-grey case failed three sample rounds with no change to the mould. The cause sat in a 500 kg masterbatch drum drawn from three grades in one season: at a 2% let-down ratio, one tonne of resin swallows 20 kg of it, and a pigment swap rewrites the profile of the batch.

Colour is the one part of a case whose recipe never reaches a drawing: resin has a grade code, hardware a mill certificate, masterbatch only a trade name.

Three routes carry substances in: pigment, carrier, plating. Each has its own denominator, from 62 g of masterbatch to a micron-scale coating. A cobalt salt at 0.2% fails inside the drum and reads 0.002% across a 5.8 kg case.

Colour is the entry point, not the finding.

2. Four groups and the limits that apply

Four groups come back from customers, with thresholds orders of magnitude apart.

REACH authorisation colour risk review on a workshop floor with a long conveyor line, seated operators, black moulded cases and a pale wooden bench
REACH authorisation colour risk review on a workshop floor with a long conveyor line, seated operators, black moulded cases and a pale wooden bench
Substance groupTypical useThresholdDuty
Azo colourantsRed, orange, yellow30 mg/kgContract report
PhthalatesDispersant, plasticiser0.1% eachNotify, SCIP
Lead compoundsLead chromate PY34500 mg/kgSubstitute
Cadmium compoundsCadmium yellow, red100 mg/kgSubstitute
Nickel platingLatches, hinges0.5 μg/cm²/weekRelease test

Azo is easily quoted out of context. Annex XVII entry 43 governs textiles and leather at 30 mg/kg per amine, so a moulded case falls outside it, yet European tenders paste that figure into the acceptance clause.

Phthalates enter through the carrier: pigment ground to a D50 of 0.3 μm needs a dispersant, and 60 Shore A on a gasket needs a plasticiser. DEHP and its three siblings are capped at 0.1% each.

Lead and cadmium come only with inorganic pigments. Lead chromate is 64% lead, so a 40% pigment load makes the masterbatch 25.6%, and a 2% let-down still leaves 0.51% in the shell. Cadmium yellow lands at 0.6%, sixty times its 100 mg/kg cap, and cheap parts still use both because they weather well.

Nickel belongs to the hardware: entry 27 caps release at 0.5 μg/cm²/week, which allows 6 μg a week across a 12 cm² latch.

3. Annex XIV and Annex XVII do different jobs

Annex XIV is an authorisation list: a sunset date applies, after which use or placing on the EU market needs a granted authorisation. Annex XVII is a restriction list: only concentration and use limits.

One substance can sit on both. DEHP carries a sunset date on Annex XIV and a 0.1% cap under entry 51: below 0.1% the restriction is not triggered, yet it stays an authorisation substance while listed on Annex XIV.

Substance groupListingTriggerConsequence
PhthalatesXIV and XVIISunset, or 0.1%Authorise or substitute
Azo colourantsXVII30 mg/kg in textileMarket ban
Lead compoundsXVII500 mg/kgMarket ban
Cadmium compoundsXVII100 mg/kgMarket ban
Nickel platingXVII0.5 μg/cm²/weekMarket ban

Few colourants reach Annex XIV; azo, lead, cadmium and nickel all sit under Annex XVII. The cost gap between authorising and substituting exceeds a factor of three.

4. The 0.1% test runs per worst-case part

The threshold is a mass fraction applied to an article. A case holds five parts, and a grey shell never shares a denominator with a red latch cover.

REACH authorisation pallet of graphite grey protective cases wrapped in stretch film beside a workbench holding blue cases and three film rolls
REACH authorisation pallet of graphite grey protective cases wrapped in stretch film beside a workbench holding blue cases and three film rolls

The sum is one division: at 0.1%, a 5.8 kg shell yields 5.8 g, a meaningless figure; a 62 g masterbatch yields 62 mg, and one impurity swing crosses that.

Substance groupMethodDetection limitCompared with
PhthalatesGC-MS, ultrasonic50 mg/kg0.1%
Azo colourantsCleavage, HPLC30 mg/kg24 amines
Lead compoundsICP-OES10 mg/kg500 mg/kg
Cadmium compoundsICP-OES5 mg/kg100 mg/kg
Nickel release168 h sweat, ICP-MS0.05 μg/cm²/weekContact area

Method follows chemistry. Phthalates take 0.5 g of cut sample, 10 mL of dichloromethane and 1 h of ultrasonic before GC-MS; azo colourants 30 min of reductive cleavage at 70 °C, then HPLC; lead and cadmium ICP-OES on a 0.2 g aliquot in 5% nitric acid.

Detection limits belong one order below the limit: cadmium at 100 mg/kg needs a report limit of 10 mg/kg, or 0.001%, and quoting 0.01% leaves borderline samples unjudgeable. Reports stay valid 12 months.

5. Article 33 and SCIP in practice

REACH authorisation duties run on two clocks. Article 33 is a reply: above 0.1%, the supplier gives the recipient enough information for safe use within 45 days, free of charge.

SCIP is a notification: above 0.1% and placed on the EU market, filed before placing, with no grace, recording a range such as 0.1% to 0.2%, not an exact figure.

Running both from one sheet works better: masterbatch, moulding and shipment lots share a line, traceability holds 3 years, and each colour change leaves 3 retained first-offs of 200 g.

The 45 days is a reply clock, not a repair clock.

Conclusion

The risk in a colourant sits outside the formulation sheet, in a supplier layer that never reaches the drawing. Fix masterbatch and hardware by colour first, then run the 0.1% calculation per worst-case part against 500 mg/kg for lead, 100 mg/kg for cadmium, 30 mg/kg for azo and 0.5 μg/cm²/week for nickel. Substitute where a pigment allows it, notify under Article 33 and SCIP where it does not, and answer inside 45 days. One 500 kg masterbatch lot, one 3-year traceability sheet and one report under 12 months old are what an audit wants.

This article covers case-side specifications only and does not address any handling, loading or use of the contents.

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