Hohenstein 2023 — EN 1811:2023 nickel-release test method bulletin

This one-page technical bulletin issued by Hohenstein in June 2023 announces that CEN (the European Committee for Standardization) has published EN 1811:2023, superseding the previous version EN 1811:2011+A1:2015. EN 1811 is the reference test method for nickel release from articles intended to come into direct and prolonged contact with the skin and is the method through which Entry 27 of Annex XVII of EU REACH Regulation (EC) No 1907/2006 is operationalised once the European Commission accepts the standard as harmonised. The bulletin identifies four operative changes versus the prior version of the standard and flags that a revised surface-area calculation for products with internal surfaces may yield higher calculated release values, making re-testing appropriate where nickel was detected in relevant quantities below the limit under the previous version.

Key numbers

Scope of the test method (as described by the bulletin)

The bulletin restates that EN 1811:2023 applies to articles intended to come into direct and prolonged contact with the skin, with the explicit exclusion of spectacle frames and sunglasses, and that both EN 1811 (with and without EN 12472) are required to be applied. The bulletin gives the following product-scope examples beyond jewellery and watch straps: metal parts of clothing and shoes, mobile phones, and belt buckles. Spectacle frames and sunglasses are excluded from the test method’s scope as described in the bulletin.

Four operative changes versus EN 1811:2011+A1:2015 (as enumerated in the bulletin)

1. Sample preparation summarised in table form with examples (Annex B). Each individual sub-part of an article must comply with the requirement of nickel released when it is in direct and prolonged contact with the skin. Homogenous sub-parts can be obtained by disassembling, cutting, or masking the article.
2. Result-interpretation rule at the 0.5 µg·cm⁻²·week⁻¹ migration-limit boundary (Clause 9.2.2.2). A result is compliant when it is ≤ 0.88 µg·cm⁻²·week⁻¹, where the previous version required < 0.88 µg·cm⁻²·week⁻¹. The 0.88 threshold reflects the 0.5 µg·cm⁻²·week⁻¹ migration limit increased by the standard’s allowance for measurement uncertainty; only the strict-inequality versus non-strict-inequality treatment has changed.
3. Each-sample compliance clarified (Clause 9.2.2.1). When more than one sample of the same article is tested, the nickel release of each sample must be compliant with the migration limit; a pass cannot be obtained by averaging across samples.
4. Combined EN 1811 + EN 12472 application clarified (Annex B.3). When uncertainty exists about the presence of nickel in the outer coating of the article, both test methods must be applied — EN 1811 alone and EN 1811 after EN 12472 accelerated wear and corrosion treatment.

Surface-area calculation change and re-testing recommendation

The bulletin warns separately from the four enumerated changes that “the changes in the calculation of the surface area for products with internal surfaces” create a risk that nickel release calculated under EN 1811:2023 will be reported at significantly higher levels than under EN 1811:2011+A1:2015 for the same article. The bulletin’s stated recommendation is that re-testing is appropriate if nickel was detected in relevant quantities below the limit when measured according to the previous version of the standard.

Methods (brief)

This is a technical bulletin, not an analytical study; the bulletin describes EN 1811:2023 rather than performing measurements. The bulletin does not specify analytical instrumentation, sample-prep details beyond the four enumerated changes, detection limits, reference materials, or replicate counts; those technical details are contained in the CEN standard EN 1811:2023 itself, which is not reproduced in the bulletin. The bulletin states that Hohenstein offers the test method as a commercial service.

Implications for the HMI corpus

The bulletin functions as a regulatory-context source for the wiki’s nickel page and for skin-contact contact-material product categories that intersect with the HMTc Category 10 (Infant and Child Durable Goods and Textiles) scope. It does not generate food-matrix occurrence values and does not contribute to any ingredient contamination_profile. Where the wiki’s existing nickel coverage references the predecessor EU Nickel Directive 94/27/EC (recorded on eu-nickel-directive-94-27-ec as it was described in LGC 2003), this bulletin documents the current operational status of the test method underlying that line of regulation. The 0.5 µg·cm⁻²·week⁻¹ migration-limit comparator is unchanged versus the historical Nickel Directive value documented in LGC 2003; the operative change is the interpretation rule at the limit and the surface-area calculation for products with internal surfaces.

For the en-1811-nickel-release method page, this source is an opportunity to record that the cited reference test method is now EN 1811:2023 rather than the earlier 2011+A1:2015 revision discussed in LGC 2003; that update is a separate edit pass downstream of this ingest, not part of it.

Limitations

The bulletin is a one-page derivative communication summarising four operative changes; it does not reproduce EN 1811:2023’s clauses verbatim, does not supply the full test protocol, and does not give numeric values for the surface-area calculation change. Any wiki claim about specific text in EN 1811:2023 beyond the four enumerated changes and the surface-area calculation warning must be sourced from the standard itself, not from this bulletin. The bulletin’s statement that the standard “is expected to be harmonized under Entry 27 of Annex XVII of EU REACH Regulation (EC) No 1907/2006 when it is accepted by the European Commission” is the standard-publisher’s expectation as of June 2023, not a record of completed harmonisation; the current harmonisation status of EN 1811:2023 under REACH Annex XVII Entry 27 is not established by this source.

Verification notes

• Document date. The bulletin’s page footer is dated 2023-06 (June 2023). The filename Hohenstein_Technical_Bulletin_Nickel_Norm_2023-07.pdf references 2023-07, which corresponds to the implementation-deadline month referenced in the bulletin body (“at the latest by August 2023”) rather than the issue month. The frontmatter year is recorded as 2023; the footer month is preserved in the publication string.
• New-page proposals (for Karen’s review, not created in this ingest): (i) regulations/eu-reach-annex-xvii-entry-27 — the live REACH restriction under which EN 1811 is harmonised. The wiki currently only has regulations/eu-nickel-directive-94-27-ec, the predecessor Nickel Directive recorded as historical-as-described-in-source. (ii) regulations/cen-en-1811-2023 or equivalent slug for the CEN test-method standard itself — the wiki currently records EN 1811 only via the testing/en-1811-nickel-release testing-method page, which is the correct primary location; a regulation page may not be necessary if the standard is captured as testing method. Surfacing both for Karen’s call on whether either page is warranted.
• Product routing. The bulletin’s product scope is broader than infant/child products (mobile phones, belt buckles, jewellery, watch straps, metal parts of clothing and shoes). The wiki’s current product taxonomy is heavily infant/child-focused. The frontmatter routes to the three existing slugs whose scope intersects the bulletin’s scope: clasps-fasteners-infant-products (folder context — fasteners, snaps, zippers in infant durable goods), childrens-jewelry, and piercing-post-assemblies (the historical evidence anchor for EN 1811 in the corpus). The bulletin is direct evidence for none of these as a contamination measurement; it is regulatory-context for all three as the operative test method that governs their nickel-release compliance.
• Brand-firewall. The bulletin names Hohenstein as the publisher and as a commercial provider of the test method service. Hohenstein is the document’s corporate author, not a brand-of-tested-product. Per the strict reading of Part 12 (locked 2026-05-17), publisher/laboratory identification is not a brand-firewall violation.
• Speciation. The bulletin discusses nickel release as a single analytical target without speciation; the frontmatter metals: [Ni] is correct.
• Audit subagent (2026-06-01) flagged childrens-jewelry as not in the 2026-05-18 taxonomy snapshot. Verified against wiki/products/childrens-jewelry.md: the slug is a live wiki product page created 2026-05-31 as a provisional_scaffold: true by ingest of nelson2023-wa-childrens-jewelry-followup, post-dating the snapshot’s generation date. The routing audit accepts childrens-jewelry as a valid routing target (this source contributes a direct_evidence row to that product page). Finding was a false positive because the taxonomy snapshot is a static 2026-05-18 export, not the live wiki state; the live product page exists and the routing layer routes to it correctly. No change to products: array.
• Audit subagent (2026-06-01) flagged the 1 week exposure-duration row in Key numbers as not stated by this source. Verified against the bulletin: the bulletin does not state exposure duration. Row removed from the Key numbers table; the wiki retains exposure-duration attribution on the en-1811-nickel-release method page via LGC 2003 as the source-of-record for that value.
• Audit subagent (2026-06-01) flagged matrices: [skin-contact-article] as not on the controlled matrices vocabulary. Verified against precedent: the existing LGC 2003 source page uses matrices: [skin-contact-article, piercing-post-assembly, stainless-steel, artificial-sweat, blood-plasma, urine], establishing skin-contact-article as the corpus convention for non-food dermal-exposure sources. Finding was a low-severity vocabulary concern; the corpus convention is followed.

Page history

The five most recent substantive edits to this page. The full version history lives in git; when DOI minting comes online (see schema docs), each entry below will also link to a version-pinned DataCite DOI.