Overview

Nickel is a common metallic element widely used in stainless steel, alloy electroplating, and jewelry manufacturing. When nickel comes into contact with the skin, it may cause contact dermatitis (nickel allergy), making it one of the most important sensitizing metals recognized by the EU. Entry 27 of Annex XVII to the EU REACH Regulation (EC 1907/2006) sets strict limits on the nickel release of nickel-containing products, and this limit has been widely adopted globally. The nickel release test evaluates the release rate of nickel ions from a product in a simulated sweat environment, rather than the total nickel content in the product. This is because nickel allergy is caused by the contact of soluble nickel ions with the skin, and merely measuring the nickel content cannot reflect the actual sensitization risk.

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Scope of Applicable Products

Applicable Product and Service Categories

The nickel release test applies to the following products: jewelry (earrings, necklaces, bracelets, rings, watch cases and straps, etc.), metal-framed glasses (metal parts in direct contact with the skin), belt buckles and metal buttons (jeans buttons, etc.), zipper pulls (parts in direct contact with the skin), metal frames of mobile phone cases, coins (some countries also have requirements for the nickel release of coins), and metal parts of medical devices that come into contact with the skin. Regulations specifically focus on metal products intended for "long-term direct contact with the skin", referring to products where the continuous contact time exceeds 30 minutes or the cumulative contact time exceeds 30 minutes within 3 days.

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Limit requirements

Technical Standards and Compliance Indicators

Nickel release restriction requirements in accordance with Entry of Annex XVII to the EU REACH Regulation

Clause	Product Category	Nickel release limit	Test Conditions
------	----------	------------	----------
Article 27	Piercing-type jewelry inserted into the human body (e.g., earring posts, nose rings, etc.)	0.2 μg/cm²/week	EN 1811 Simulated Artificial Sweat Test
Article 28	Metal products in long-term direct contact with the skin (watch cases, watch straps, rings, bracelets, spectacle frames, belt buckles, etc.)	0.5 µg/cm²/week	EN 1811 Simulated Artificial Sweat Test
Article 29	Nickel-containing coating on the surface of metal products not in prolonged or direct contact with the skin	No specific release limit, but the coating is required to effectively prevent nickel release after 2 years of normal use.	EN 1811 test after EN 12472 wear and corrosion pretreatment

The above limits apply to the nickel release from parts of the product in direct and prolonged contact with the skin, with a testing period of 1 week (168 hours).

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Testing Methods and Standards

Core Testing Items and Specifications

The nickel release test method is in accordance with the following standards

EN 12472:2005Wear and corrosion simulation test for nickel release from products with nickel-containing coatings. First, wear simulation is performed on the product using an abrasive medium (such as sandpaper or abrasive paste), followed by EN 1811 testing.

CR 12471:2004Rapid screening method for nickel release (xylene dithiol-dimethylglyoxime colorimetric method), suitable for rapid qualitative screening.

Evaluation of Test ResultsThe EN 1811:2015 version specifies the uncertainty evaluation method. For products with prolonged contact with skin, test results lower than 0.11 micrograms/cm²/week are assessed as compliant, higher than 0.88 micrograms/cm²/week are assessed as non-compliant, and those between the two are deemed inconclusive and require re-testing. The assessment criteria were adjusted after the revision of the 2019 version.

EN 1811:2015+A1:2019: Reference test method for nickel release in products intended for direct and prolonged contact with the skin. The sample is immersed in simulated artificial sweat (composition:0.5 % NaCl

0.1 %Lactic acid

0.1 %Urea

0.0475 %Ammonium chloride

0.0475 %Acetic acid, pH adjusted to 5.5 ± 0.05), at 30 ±2 °Ccontinuously immersed for 168 hours (7 days), maintaining a uniform solution by stirring. After the immersion, the nickel content in the solution is determined using Graphite Furnace Atomic Absorption Spectrometry (GFAAS) or Inductively Coupled Plasma Mass Spectrometry (ICP-MS). It is then converted to the nickel release rate (μg/cm²/week) based on the contact area.

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Certification Process

Complete steps from application to certification

Nickel Release Testing Compliance Process
Step 1	Confirm whether the product falls within the scope of nickel release control (metal products intended for direct and prolonged contact with the skin).
Step 2	Determine the applicable regulatory provisions for the product (Articles 27/28/29 of REACH).
Step 3	Conduct sampling on the metal parts of the product that come into contact with the skin.
Step 4	Submit samples to an ISO 17025 accredited laboratory for EN 1811 or EN 12472 testing.
Step 5	The laboratory issues a nickel release test report.
Step 6	Determine compliance against the limit values and include the report in the REACH compliance documents.

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Required Documents and Notes

Checklist of Required Documents and Materials for Application

To apply for the nickel release test, the following information must be provided: Product name and model.

Description of skin-contact metal parts in the product (Material

Sample quantity (at least 2 to 3 samples per metal part)

Explanation of applicable regulatory clauses. Note: Nickel release testing focuses on the surface release rate, which is independent of the total nickel content in the product. Even for stainless steel (containing about8 %to12 %), if properly surface-treated (such as chrome plating or palladium plating), it may also pass the nickel release test. The nickel release of low-nickel stainless steels (such as 304 and 316 stainless steel) is usually within the compliant range, but high-nickel alloys (such as cupronickel) may exceed the limit. Surface coatings (such as gold plating

Electroplated rhodium) can effectively prevent nickel release, but the coating must have sufficient thickness and wear resistance. The EN 12472 wear test simulates the effect of the coating after 2 years of use, and it is considered compliant only if the nickel release remains below the limit after the wear test. The nickel release test is a destructive test, and samples cannot be recovered after immersion. Different markets (EU

nickel release standards such as China's GB/T 19719) are fundamentally consistent, but there may be slight differences in the determination methods.

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