Nickel Release Test — EN 1811 / EN 12472 / REACH Annex XVII Entry 27

What Is Nickel?

The nickel release test holds the metal product in artificial sweat solution for a week and measures the amount of nickel released per unit surface area per week. For coated products, wear and corrosion treatment per EN 12472 is applied before measurement; this represents the coating wearing down over the product's use.

Purpose of Nickel

The purpose is to show products in prolonged skin contact comply with the nickel release limits in REACH Annex XVII Entry 27. Nickel is among the most common causes of contact allergy, and sensitisation, once it develops, is permanent.

Which Products Is Nickel Applied To?

Earrings, necklaces, rings and jewellery
Piercing and body jewellery
Watch straps and buckles
Zips, snap fasteners, buttons and belt buckles
Eyeglass frames

In Which Sectors Is Nickel Used?

CosmeticsChemistryRetailTextilesLeatherMetalRetail

Standards Related to Nickel

TS EN 1811 (nickel release — reference test method)
TS EN 12472 (simulation of wear and corrosion for coated items)
TS EN 16128 (spectacle frames — nickel release)
TS EN ISO 105-E04 (artificial perspiration solution composition reference)

Nickel Conditions

Solution: Artificial sweat solution defined in EN 1811
Time and temperature: One-week immersion defined in the standard, at controlled temperature
Pre-treatment: Wear and corrosion per EN 12472 for coated products
Unit: µg/cm²/week

Equipment for Nickel

ICP-MS / ICP-OES
EN 12472 wear and corrosion rig
Controlled-temperature incubator
Surface area measurement systems

Sample Requirements for Nickel

Product as offered for sale
Skin-contact surfaces must be identified
Coating type and thickness must be provided
The test is destructive; multiple specimens may be required

Duration of Nickel

The immersion time defined in the standard is one week; for coated products, the EN 12472 pre-treatment adds to this. Total duration is therefore at least several weeks.

Nickel Procedure

1Skin-contact surfaces are identified and their area calculated.
2Wear and corrosion per EN 12472 is applied to coated products.
3The specimen is immersed in artificial sweat solution.
4It is held for one week at the defined temperature.
5The solution is taken and nickel concentration is measured by ICP.
6The result is calculated per unit area and week.

Nickel Acceptance Criteria

REACH Annex XVII Entry 27 defines separate nickel release limits for items inserted into pierced ears and body parts and other items in prolonged skin contact; the limit is markedly stricter for items inserted into pierced parts. Current limits are confirmed from the regulatory text.

Evaluation of Results

The EN 12472 pre-treatment cannot be skipped for coated products: a new product can be below the limit, but the underlying nickel is exposed once the coating wears. The test is therefore performed after a wear treatment representing two years of normal use. Measurement uncertainty is decisive for results close to the limit and is always stated in the report.

Nickel Report

Product identification, coating type and skin-contact surfaces
Surface area calculation
Pre-treatment applied (EN 12472) information
Nickel release result (µg/cm²/week) and measurement uncertainty
Regulatory limit compared against

Accreditation

EUROLAB holds internationally recognised accreditation obtained from accreditation bodies party to the IAF and ILAC multilateral recognition arrangements, under ISO/IEC 17025 for laboratory testing, ISO/IEC 17020 for inspection and surveillance, and ISO/IEC 17021-1 and ISO/IEC 17065 for system and product certification. This chain ensures the reports and certificates issued are accepted worldwide.

Whether this test can be offered within accredited scope depends on your product and the standard applied; since accreditation is method-based, the scope is confirmed in writing at the quotation stage.

Scope and authorisations

Related Regulations

(EC) 1907/2006 REACH Annex XVII Entry 27

Kozmetik Testleri — What Does This Testing Field Cover?

The section below describes the field that the Nickel test belongs to; the conditions and acceptance criteria of this particular test are given in the sections above. The scope specific to your product is confirmed in writing at the quotation stage.

Cosmetics testing shows that a product stays microbiologically safe throughout its use, delivers the performance it claims and contains no restricted substances. There is NO PRODUCT APPROVAL in this family: no authority approves a cosmetic product; responsibility rests entirely with the manufacturer and with the responsible person established in the EU.

This responsibility model shapes how the field works. Before the product is placed on the market a product information file (PIF) is prepared, a safety assessment (CPSR) is carried out and notification is completed. Inspection comes afterwards and asks for the file; if the file is incomplete the product is withdrawn from the market. Test reports form the evidence base of that file.

On the microbiological side there are two different questions and each is answered by a separate test. The CURRENT microbiological quality of the product is measured by enumeration and testing for specified microorganisms. The EFFECTIVENESS of the preservative system is examined by deliberately inoculating the product with microorganisms (challenge test): can the product resist repeated contamination throughout its use? A jar of cream is touched by a finger at every use; the preservative system must cope with that.

On the performance side, claim substantiation studies are carried out. For sunscreens, determination of SPF and UVA protection and measurement of water resistance are mandatory and are the basis of the value declared on the label. Evidence is also produced by in vivo or in vitro methods for claims such as moisturisation, appearance of wrinkles, hair care and colour retention.

On the chemical side, banned and restricted substances are screened: heavy metals, prohibited colorants, preservative concentrations, UV filter levels and contaminants such as nitrosamines. Products containing nanomaterials carry a separate notification obligation.

The BAN ON ANIMAL TESTING is the most defining constraint of the field. Animal testing cannot be carried out on finished products or ingredients, and a product tested on animals cannot be placed on the market. Alternative in vitro methods (reconstructed human skin models, cell culture based tests) are therefore at the centre of the field, and toxicological assessment rests largely on existing data, read-across approaches and in vitro results.

Stability and packaging compatibility studies determine shelf life and the period after opening (PAO). The interaction of the product with its packaging is also assessed: an active substance may migrate into the packaging, and substances that should not be present may pass from the packaging into the product.

On the process side, good manufacturing practice is demonstrated through ISO 22716; this is separate from product testing but a mandatory part of the file.

Method groups in this field

Microbiological quality
Enumeration of aerobic mesophilic bacteria, yeasts and moulds; testing for Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans and E. coli.
Preservative efficacy
Resistance of the preservative system to repeated contamination by challenge test (ISO 11930).
Sun protection
In vivo SPF determination, in vitro UVA protection determination, water resistance and critical wavelength measurements.
Chemical analysis
Heavy metals, banned and restricted substances, quantification of preservatives and UV filters, contaminant screening.
Safety assessment
In vitro irritation and sensitisation methods, toxicological risk assessment, exposure calculations.
Stability and compatibility
Real-time and accelerated stability, packaging compatibility, PAO determination, sensory and physicochemical monitoring.

Commonly confused in this field

There is NO CE marking on cosmetics; conformity is demonstrated through the PIF, the safety assessment and notification.
The responsible person must be established in the EU; unless the exporter arranges this, the product cannot be placed on the market.
Microbiological quality and preservative efficacy are different tests; a product that comes out clean may still have a weak preservative system.
The animal testing ban covers ingredients too; animal test data generated for another market creates a problem of use.
An SPF claim must be supported by measurement; a formulation change requires a new measurement.
A change of packaging may require the stability and compatibility studies to be repeated.

Which decisions these results support

The product information file and the safety assessment
Verification of the preservative system design
Substantiation of SPF and efficacy claims
Determining shelf life and the period after opening
Compliance with destination market restrictions for export

Related Tests

Frequently Asked Questions About Nickel

Our product doesn't contain nickel — is testing needed?

The claim should be backed by analysis. Alloy composition can vary between suppliers, and the base metal under a coating usually contains nickel. Most buyers also require a document.

Is a total nickel analysis sufficient?

No. The legislation limits the amount RELEASED in skin contact, not total content. An alloy with high nickel content can stay below the limit with a good coating; the reverse is also possible.