CIRS 2023 — REACH Annex XVII consolidated reproduction (last update 2023-07-17)

This 64-page document is a third-party reproduction by CIRS – C&K Testing (Hangzhou C&K Testing Technic Co., Ltd) of Annex XVII to EU REACH Regulation (EC) No 1907/2006 — the consolidated list of restrictions on the manufacture, placing on the market, and use of certain dangerous substances, mixtures, and articles within the European Union. The header states “Last update: 2023-07-17”, and the reproduction covers entries 1 through 77 of the Annex in the canonical “Column 1 (substance) / Column 2 (conditions of restriction)” tabular format. The Appendices internally referenced by the entries (notably Appendix 8–14: the lists of aromatic amines released from azodyes, of substances restricted in clothing/textiles, of substances restricted in tattoo inks, and of formaldehyde-emission test conditions) are not reproduced in this PDF — the reproduction is the entries table only. The document is not a measurement study; it is reproduced regulatory text whose value to HMI is as a single consolidated reading of the heavy-metal-relevant restrictions (entries 16, 17, 18, 18a, 19, 20, 21, 23, 27, 47, 62, 63, 75) as of mid-2023. The canonical citation for any operative HMI claim remains the EUR-Lex consolidated version of Annex XVII or the specific amending Commission Regulation; this source is the working consolidation for cross-reference.

Key numbers — heavy-metal restrictions reproduced

The table below extracts the HMI-relevant numerical restrictions from the heavy-metal entries reproduced in the document. Concentrations are given in the basis the entry uses (% by weight of the substance or article, or release/migration rates where applicable). Entry numbers correspond to the reproduction’s entry numbers, which match the canonical REACH Annex XVII entry numbering.

Lead and lead compounds

Cadmium and cadmium compounds

Entry 23. Cadmium (CAS 7440-43-9; EC 231-152-8) and its compounds.

Mercury and mercury compounds

Arsenic and arsenic compounds

Entry 19. Arsenic compounds.

Organostannic (organotin) compounds

Entry 20. Organostannic compounds.

Nickel

Entry 27. Nickel (CAS 7440-02-0; EC 231-111-4) and its compounds.

Chromium VI

Entry 47. Chromium VI compounds.

Tattoo-ink CMR restriction (entry 75) — nickel and chromium VI signalling

Entry 75 is a CMR-substance restriction on mixtures for tattooing purposes (in force from 4 January 2022 for most substances). The HMI-relevant numbers it reproduces for heavy metals are in the mandatory labelling text required from 4 January 2022 (paragraph 7):

• “Contains nickel. Can cause allergic reactions.” must appear on a tattoo-ink mixture if the mixture contains nickel below the concentration limit specified in Appendix 13 (Appendix not reproduced in this PDF).
• “Contains chromium (VI). Can cause allergic reactions.” must appear on a tattoo-ink mixture if the mixture contains chromium (VI) below the concentration limit specified in Appendix 13 (Appendix not reproduced in this PDF).

For substances in Appendix 13 (the appendix-specific concentration table not reproduced here), the concentration limit specified in Appendix 13 applies (paragraph 1(h)); a substance not in Appendix 13 falling within general points (a)–(g) takes the strictest applicable concentration limit, with the carcinogen/germ-cell mutagen 1A/1B/2 limit at ≥ 0.00005 % by weight and the reproductive toxicant 1A/1B/2 limit at ≥ 0.001 % by weight as the operative CMR-class thresholds (paragraph 1(a), 1(b)).

Cross-reference summary by metal

Methods (brief)

This is reproduced regulatory text, not an analytical study. The document does not specify measurement methods; the entries themselves reference CEN test methods (entry 27.3 for nickel release; entry 50 references EN 16143:2013 for PAH in extender oils; entry 47.4 references the CEN standard for soluble chromium VI in cement; entry 50.2 references ISO 21461 for Bay protons in rubber) which are external to this PDF. Limits are stated as concentration in mass-percent of substance, mass-percent of metal, mg/kg, µg/cm²/week (migration), or µg/cm²/hour (release). The reproduction preserves the EU regulatory unit conventions verbatim and uses the EU continental decimal separator (comma in some entries, period in others) inconsistently as reproduced from the underlying text.

Scope of the reproduction (entries 1–77, what is and is not heavy-metal-relevant)

The reproduction contains entries 1, 2, 3, 4, 5, 6 (asbestos fibres), 7, 8, 9, 10, 11, 12–15, 16, 17, 18, 18a, 19, 20, 21, 23, 24, 25, 26, 27, 28–30 (CMR cat. 1A/1B class), 31 (creosote), 32–38 (chlorinated solvents), 40 (flammable aerosols), 41 (hexachloroethane in non-ferrous metal manufacturing), 43 (azocolourants and azodyes), 45 (diphenylether octabromo derivative), 46/46a (nonylphenol and NPE), 47 (chromium VI), 48 (toluene), 49 (trichlorobenzene), 50 (polycyclic aromatic hydrocarbons in extender oils, tyres, granules/mulches for synthetic turf, articles for general public, toys/childcare articles), 51 (DEHP, DBP, BBP, DIBP phthalates), 52 (DINP, DIDP, DNOP phthalates), 54 (DEGME), 55 (DEGBE), 56 (MDI), 57 (cyclohexane), 58 (ammonium nitrate), 59 (dichloromethane), 60 (acrylamide), 61 (DMF), 62, 63, 64 (1,4-DCB), 65 (inorganic ammonium salts), 66 (BPA in thermal paper), 68 (C9–C14 PFCAs), 69 (methanol), 70 (D4/D5 cyclosiloxanes), 71 (NMP), 72 (textile substances in Appendix 12), 73 (TDFAs), 74 (diisocyanates), 75 (tattoo-ink CMR restriction), 76 (DMF), 77 (formaldehyde and formaldehyde-releasing substances in articles and road vehicles).

Heavy-metal entries reproduced: 16, 17, 18, 18a, 19, 20, 21, 23, 27, 47, 62, 63, 75 (the last for the nickel/chromium-VI labelling clause within the CMR tattoo-ink restriction).

Non-reproduced content within Annex XVII relevant to HMI but referenced by the entries: Appendix 8 (aromatic amines released from azodyes), Appendix 11 (substances for which CMR cat. 1A/1B derogation applies), Appendix 12 (substances in clothing/textiles with per-substance concentration limits — operative for chromium VI 1 mg/kg textile-extractable and for several other metals in the textile-clothing scope), Appendix 13 (tattoo-ink concentration limits for specific substances including nickel and chromium VI), and Appendix 14 (formaldehyde-emission test conditions). The PDF references these Appendices but does not reproduce them; any HMI claim that depends on Appendix-table concentration values cannot be sourced from this reproduction.

Implications for the HMI corpus

This reproduction serves as a working consolidated reading of Annex XVII heavy-metal restrictions for HMI cross-reference against children’s-product and textile/leather/jewellery sources already in the corpus. Specific intersections:

• The 0.5 µg/cm²/week nickel-release migration limit on skin-contact articles (entry 27.1(b)) and the < 0.2 µg/cm²/week post-assembly migration limit (entry 27.1(a)) are the operative restriction underlying the test-method update documented in Hohenstein 2023; the values are unchanged from the predecessor EU Nickel Directive 94/27/EC recorded in eu-nickel-directive-94-27-ec.
• The 0.05 % by weight lead-in-mouthable-children’s-articles threshold (entry 63.7) with its 0.05 µg/cm²/h release-rate alternative and 5-cm-mouthability rule is the EU counterpart to ASTM/CPSC lead-in-children’s-product limits recorded on US regulatory sources in the corpus; the EU exemption for brass-alloy articles ≤ 0.5 % lead is a category-specific carve-out HMI should note when evaluating brass-containing children’s metal products.
• The cadmium 0.01 % in jewellery metal parts (entry 23.10), 0.01 % in plastic articles (entry 23.1), and 0.1 % in painted articles (entry 23.2) are the EU operative limits against which ECHA’s 2023 CMR-childcare-articles investigation report (ECHA 2023) proposes the more protective LOQ-derived 10 mg Cd/kg content and 0.1 mg Cd/kg extractable limits for childcare articles specifically.
• The DOT 0.1 % organotin restriction in nappies, childcare articles, female hygiene products, textile skin-contact articles, gloves, footwear, and wall/floor coverings (entry 20.6) is direct evidence for the diapers-and-components page and for any future childcare-textile product page; ECHA 2023 proposes the more protective 1 mg/kg sum of DOT/DBT for childcare-article content.
• The chromium VI ≥ 3 mg/kg leather-skin-contact prohibition (entry 47.5 and 47.6) is the operative restriction the corpus cross-references when discussing children’s leather goods and shoes.

Limitations

The CIRS reproduction is a third-party consolidation; the canonical citation for any operative HMI use (e.g. an HMTc threshold rationale tag of regulatory-alignment per CLAUDE.md Part 19) is the EUR-Lex consolidated version of Annex XVII or the specific amending Commission Regulation, not this snapshot. Specific limitations:

• The reproduction does not enumerate which amending Commission Regulations are included or excluded; entries amended after 17 July 2023 will not be reflected.
• Appendices 8 through 14 (notably Appendix 12 textile-substance limits and Appendix 13 tattoo-ink limits) are not reproduced; any claim that depends on Appendix-table concentration values must be sourced from the underlying regulation directly.
• Several entries reproduced in the document have been amended in subsequent Commission Regulations (for example, entry 51 phthalates received a substance addition in early 2024; entry 23 cadmium derogation review under Article 69 paragraph 4 was due for re-evaluation by 31 December 2017 and the outcome is not reproduced); the snapshot does not flag where it is current versus historical.
• Entries reference external CEN/ISO test methods (EN 16143:2013 for extender-oil PAH analysis; ISO 21461 for rubber Bay protons; an unspecified CEN standard for soluble Cr-VI in cement; CEN standards for nickel release) which are not reproduced in this PDF.
• The reproduction uses both period and comma as decimal separators across entries (e.g. “0.01 %” in entry 23.1 vs “0,01 % by weight” in entry 23.2) inconsistently, preserving the inconsistency of the underlying EU text; HMI numerical values quoted in the Key numbers table are normalised to period as the decimal separator.
• Entries 22, 33, 39, 42, 44, 53, and 67 are absent from the reproduction (consistent with the canonical Annex XVII where some entry numbers have been vacated by repeals or remain reserved).

Verification notes

• Document provenance. The header on every page reads “CIRS – C&K Testing www.cirs-ck.com/en”; the footer of the final page lists “CIRS | Hangzhou C&K Testing Technic Co., Ltd Web: www.cirs-ck.com/en Phone: +86-(0)571-87206587 FAX: +86-(0)571-89900719 E-mail: test@cirs-group.com”. CIRS is identified as a Chinese chemical-compliance testing and consulting firm; the document is a CIRS-branded reproduction of EU regulatory text, not an EU institutional publication.
• Date anchor. The document states “Last update: 2023-07-17” on the first page beneath the title. The frontmatter year is 2023; the publication string preserves the full date.
• Entry-numbering gaps. Entries 22, 33, 39, 42, 44, 53, and 67 are absent from the document. This matches the canonical Annex XVII where some entry numbers have been vacated by repeals; the gaps are not reproduction errors.
• Decimal-separator inconsistency. The reproduced text uses period and comma decimal separators inconsistently across entries (e.g. “0.01 %” in entry 23.1 and “0,01 % by weight” in entry 23.2 within the same entry). The inconsistency is preserved in the underlying EU text and reproduced verbatim. Key numbers in this source page are normalised to period.
• Speciation. Entries 18 (mercury compounds, broad scope), 18a (elemental mercury), and 62 (five specific phenylmercury compounds) are distinct entries with distinct restrictions; the frontmatter metals: [..., tHg, iHg, ...] is intentional (tHg for the total-mercury restriction scope of entry 18 and iHg for the elemental-mercury restriction scope of entry 18a; phenylmercury sits under tHg). The arsenic entry 19 is restricted to compounds generally without iAs/tAs speciation in the regulatory text, so the frontmatter uses tAs. The chromium VI restriction (entry 47) is recorded as Cr-VI. Organotin compounds are aggregated as Sn per HMI’s metals: [..., Sn, ...] convention; TBT, TPT, DBT, DOT, and DBB are sub-species under Sn.
• Audit subagent (2026-06-01) flagged Hg as not in the controlled metals abbreviation vocabulary (the documented set is Pb, Cd, iAs, tAs, iHg, MeHg, tHg, Ni, Al, Cr, Cr-VI, Sn, Sb, U per the system-prompt vocabulary referenced in taxonomy-snapshot). Verified against the controlled vocabulary — finding was correct. The elemental-mercury restriction in entry 18a falls under inorganic mercury (Hg⁰ and Hg²⁺) per the speciation flag, so iHg is the controlled-vocabulary equivalent. Replaced Hg with iHg in the metals array. The wiki body and verification notes have been updated to reflect this. Some other source pages in the corpus use the bare Hg flag inconsistently; that is a corpus-wide vocabulary drift not addressed by this ingest.
• Audit subagent (2026-06-01) flagged childrens-jewelry and clasps-fasteners-infant-products as not in the 2026-05-18 taxonomy snapshot. Verified against wiki/products/childrens-jewelry.md and wiki/products/clasps-fasteners-infant-products.md: both pages exist on disk and are valid routing targets (the routing audit accepts both as live product pages). Findings were false positives because the taxonomy snapshot is a static 2026-05-18 export, not the live wiki state; the live product pages exist and the routing layer routes to them correctly. No change to products: array. The auditor self-corrected four other product-slug findings (piercing-post-assemblies, toys-painted, toys-substrate-materials, tattoo-inks) for the same reason during its own re-check.
• Brand-firewall. CIRS is the publisher of the reproduction, not a brand of measured product; per the Part 12 strict reading (locked 2026-05-17), publisher identification is not a brand-firewall violation. No brand names appear in the underlying REACH regulatory text reproduced.
• Wiki/HMTc firewall. The reproduction reports the EU operative restriction as it is; it does not synthesise across the corpus, does not propose HMTc thresholds, and does not advocate tightening or loosening any value. The “Implications for the HMI corpus” section above flags cross-references to existing wiki sources without making synthesis claims.
• New-page proposals (for Karen’s review, not created in this ingest):
  • regulations/eu-1907-2006-reach-annex-xvii — the umbrella regulation page for Annex XVII as a whole. Multiple existing HMI sources reference Annex XVII in prose (Hohenstein 2023; ECHA 2023; entries 27, 47, 63 in particular); a dedicated regulation page would let those sources route to a canonical page. The wiki currently has regulations/eu-nickel-directive-94-27-ec (the predecessor Nickel Directive) but no Annex XVII page.
  • Alternative: per-entry regulation pages (regulations/reach-annex-xvii-entry-27, regulations/reach-annex-xvii-entry-63, etc.) following the per-entry granularity of the canonical text. Either umbrella or per-entry — Karen’s call.
• Routing scope. The reproduction’s product scope is broader than the HMI wiki product taxonomy (which is primarily food and personal-care focused with selected childcare-article slugs). The frontmatter routes to the eight existing product slugs whose scope intersects with the reproduction’s heavy-metal entries: childrens-jewelry (entries 23.10, 27.1(b), 63.1), piercing-post-assemblies (entry 27.1(a)), clasps-fasteners-infant-products (entry 27.1(b) for rivets/zippers/metal marks in garments), diapers-and-components (entry 20.6 DOT in nappies), infant-clothing (entry 20.6 DOT in textile articles intended for skin contact; entry 47.5/47.6 Cr-VI in leather parts of children’s footwear and clothing accessories), toys-painted (entry 23.2 Cd in painted articles; entry 63.7 Pb in articles for general public placed in mouth by children), toys-substrate-materials (entry 23.1 Cd in plastic materials; entry 63.7 Pb in articles placed in mouth by children; entry 20.6 DOT in childcare articles), and tattoo-inks (entry 75 CMR tattoo-ink restriction including the nickel/chromium-VI labelling clauses). This routing treats the source as regulatory_context for product pages whose scope intersects the entries; the source is not direct contamination evidence (no measurements) for any of these product categories.
• Matrices. The reproduction is not a food or skin-contact-material measurement study; matrices: [] is correct.
• Jurisdictions. EU only; the restrictions apply throughout the European Economic Area via the REACH framework.

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.