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Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast)

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Overview

This is the EU’s horizontal cosmetic-products regulation: a single binding legal instrument that replaced Directive 76/768/EEC and applies directly in all EU Member States from 11 July 2013. Its relevance to Heavy Metal Index is structural rather than empirical. The regulation does not measure or estimate contamination concentrations in finished cosmetics; it defines (a) which metals are prohibited as intentional ingredients (Annex II), (b) which metal-containing substances are permitted under explicit restriction (Annex III selenium disulphide for anti-dandruff shampoos, aluminium zirconium complexes in non-aerosol antiperspirants, strontium chloride in oral products; Annex V Thiomersal and phenylmercuric salts as eye-product preservatives at 0.007 % as Hg), and (c) the legal status of non-intended trace-level heavy-metal impurities (Article 17). Article 17 is the provision under which every downstream EU-jurisdiction heavy-metal-in-cosmetics study, agency guidance value, and national surveillance threshold operates: trace presence of an Annex II substance from raw-material impurities, the manufacturing process, storage or packaging migration is permitted only where technically unavoidable in good manufacturing practice AND consistent with Article 3 (safety). The regulation itself sets no numeric trace limits for prohibited metals; that gap is what national feasibility studies (A Feasibility Study Investigating Action Limits for Certain Heavy Metal Impurities in Cosmetic Products), agency guidance documents (German BVL, Health Canada, KvW, ASEAN, ICCR), and Member State action limits exist to fill.

Key numbers

Annex II — list of substances prohibited as intentional ingredients in cosmetic products (metals only; Annex II runs entries 1-1328 total)

All ” and its compounds” entries below are absolute prohibitions on intentional inclusion. Each is cross-referenced by CAS number for the elemental metal; the entry covers the element and its compounds.

  • Entry 40 — Antimony and its compounds (CAS 7440-36-0; EC 231-146-5).
  • Entry 43 — Arsenic and its compounds (CAS 7440-38-2; EC 231-148-6).
  • Entry 46 — Barium salts, with the exception of barium sulphide under the conditions laid down in Annex III, and of barium sulphate, lakes, salts and pigments prepared from colouring agents when listed in Annex IV.
  • Entry 54 — Beryllium and its compounds (CAS 7440-41-7; EC 231-150-7).
  • Entry 68 — Cadmium and its compounds (CAS 7440-43-9; EC 231-152-8).
  • Entry 97 — Chromium; chromic acid and its salts (CAS 7440-47-3; EC 231-157-5). The entry text “Chromium; chromic acid and its salts” is read by the European Commission as covering chromium metal and Cr(VI) salts; Cr(III) ingredients (e.g. CI 77288 chromium oxide green) enter the legal market via the Annex IV colorant route.
  • Entry 101 — Cobalt benzenesulphonate (CAS 23384-69-2). Entries 453-454 add cobalt dichloride (CAS 7646-79-9) and cobalt sulphate (CAS 10124-43-3) as separately prohibited cobalt-CMR compounds.
  • Entry 221 — Mercury and its compounds, except those special cases included in Annex V (CAS 7439-97-6; EC 231-106-7). The Annex V exceptions are Thiomersal and Phenylmercuric salts as preservatives in eye products only (entries 16-17).
  • Entry 289 — Lead and its compounds (CAS 7439-92-1; EC 231-100-4).
  • Entry 297 — Selenium and its compounds, with the exception of selenium disulphide under the conditions set out under reference No 49 in Annex III (CAS 7782-49-2; EC 231-957-4).
  • Entry 309 — Neodymium and its salts (CAS 7440-00-8).
  • Entry 312 — Tellurium and its compounds (CAS 13494-80-9).
  • Entry 317 — Thallium and its compounds (CAS 7440-28-0; EC 231-138-1).
  • Entry 391 — Zirconium and its compounds, with the exception of the substances listed under reference number 50 in Annex III, and the zirconium lakes, pigments or salts of the colouring agents when listed in Annex IV (CAS 7440-67-7).
  • Entries 455-460 — Specific Ni(II) and Ni-CMR compounds: Nickel monoxide (CAS 1313-99-1), Dinickel trioxide (CAS 1314-06-3), Nickel dioxide (CAS 12035-36-8), Trinickel disulphide (CAS 12035-72-2), Tetracarbonylnickel (CAS 13463-39-3), Nickel sulphide (CAS 16812-54-7). Nickel metal as such is not on the Annex II banned list by name; its presence in cosmetics is governed via the Article 17 trace-impurity rule together with Cr(VI)/nickel (Ni) occupational and consumer-allergen guidance frameworks outside this regulation.

Annex III — substances permitted in cosmetic products only under specified restrictions (metal-containing entries)

  • Entry 49 — Selenium disulphide (INCI: Selenium sulfide; CAS 7488-56-4; EC 231-303-8). Permitted in anti-dandruff shampoos at a maximum concentration in the ready-for-use preparation of 1 %. Mandatory label warnings: “Contains selenium disulphide” and “Avoid contact with eyes or damaged skin.”
  • Entry 50 — Aluminium zirconium chloride hydroxide complexes (Al(x)Zr(OH)yClz) and aluminium zirconium chloride hydroxide glycine complexes. Permitted in anti-perspirants at a maximum concentration in the ready-for-use preparation of 20 % (as anhydrous aluminium zirconium chloride hydroxide) and 5.4 % (as zirconium). Conditions: (1) the ratio of aluminium atoms to zirconium atoms must be between 2 and 10; (2) the ratio of (Al + Zr) atoms to chlorine atoms must be between 0.9 and 2.1; (3) not to be used in aerosol dispensers (sprays). Mandatory warning: “Do not apply to irritated or damaged skin.”
  • Entry 57 — Strontium chloride hexahydrate (INCI: Strontium chloride; CAS 10476-85-4; EC 233-971-6). Two permitted product-type rows: (a) oral products at a maximum concentration in the ready-for-use preparation of 3.5 % (as strontium); (b) shampoo and face products at a maximum concentration of 2.1 % (as strontium). For each row, when mixed with other permitted strontium compounds the total strontium content must not exceed the row’s per-row cap (3.5 % oral / 2.1 % shampoo and face). Mandatory label statements: “Contains strontium chloride” and (for oral products) “Frequent use by children is not advisable.” Strontium acetate hemihydrate appears separately at Annex III entry 58 with the same 3.5 % oral cap and mixed-compound rule.
  • Entry 101 — Pyrithione zinc (CAS 13463-41-7; EC 236-671-3). Permitted in leave-on hair products at a maximum concentration in the ready-for-use preparation of 0.1 %, for purposes other than inhibiting the development of micro-organisms in the product (i.e. non-preservative functional use; the purpose must be apparent from the presentation of the product). Preservative-function use of pyrithione zinc routes through Annex V entry 8 (hair products, 1.0 %, rinse-off only).

Annex IV — colorants permitted in cosmetic products

Annex IV lists permitted colorants, including lake pigments and substances prepared from heavy-metal-containing salts (e.g. titanium dioxide, iron oxides, chromium oxide green CI 77288, manganese violet CI 77742). Heavy metals enter the legal cosmetics market predominantly through this route — as constituents of Annex IV colorant pigments — rather than as intentional bulk ingredients. Annex II entries 40, 43, 68, 289, 221 etc. read together with Annex IV mean: the elemental metal cannot be added on its own; lakes, pigments and salts of authorised Annex IV colorants are permitted within their listed conditions. Article 14(1)(c)(i) makes this explicit.

Annex V — preservatives permitted in cosmetic products (mercury entries)

  • Entry 16 — Thiomersal (INCI: Thimerosal; CAS 54-64-8; EC 200-210-4). Permitted only in eye products at a maximum concentration of 0.007 % (calculated as Hg). When mixed with other mercurial compounds authorised by this Regulation, the maximum concentration of mercury (Hg) remains fixed at 0.007 %. Mandatory label statement: “Contains Thiomersal.”
  • Entry 17 — Phenylmercuric salts, including borate (Phenyl Mercuric Acetate CAS 62-38-4; Phenyl Mercuric Benzoate CAS 94-43-9; EC 200-532-5, 202-331-8). Permitted only in eye products at a maximum concentration of 0.007 % (calculated as Hg), with the same mixed-mercurial cap rule as entry 16. Mandatory label statement: “Contains Phenylmercuric compounds.”

Article 17 — Traces of prohibited substances (the contamination-relevant clause)

Full text: “The non-intended presence of a small quantity of a prohibited substance, stemming from impurities of natural or synthetic ingredients, the manufacturing process, storage or migration from packaging, which is technically unavoidable in good manufacturing practice, shall be permitted provided that such presence is in conformity with Article 3.”

Three conditions are cumulative. (i) “Non-intended” excludes deliberate inclusion. (ii) “Technically unavoidable in good manufacturing practice” (cross-referencing Article 8 GMP) is the engineering-feasibility test. (iii) Article 3 safety: the cosmetic product, taking into account presentation, labelling, instructions for use and disposal, “shall be safe for human health when used under normal or reasonably foreseeable conditions of use.” Article 17 sets no numeric trace ceiling for any Annex II substance. Numeric ceilings are filled in at Member-State level by surveillance authorities (e.g. the German Federal Office of Consumer Protection and Food Safety / BVL guidance values; the Dutch KvW 1980 guidance values), by national feasibility studies (e.g. A Feasibility Study Investigating Action Limits for Certain Heavy Metal Impurities in Cosmetic Products), by international cooperation guidance (ICCR lead (Pb) ≤10 mg/kg in finished cosmetic products excluding oral-cavity products; ICCR Hg ≤1 mg/kg as total Hg), and at the regional level outside the EU by binding regulatory ceilings (China NMPA, Thailand). Within EU law itself the trace-impurity ceiling for prohibited heavy metals is whatever a competent authority can defend as exceeding the “technically unavoidable in GMP” test on the facts of the specific product.

Article 10 + Annex I — vulnerable-population safety-assessment requirement

Annex I Part B Section 3 (Cosmetic Product Safety Assessment, Reasoning) requires “inter alia a specific assessment for cosmetic products intended for use on children under the age of three and for cosmetic products intended exclusively for use in external intimate hygiene.” Recital 34 carries the corresponding general principle for vulnerable-population exposure: “the assessment by the SCCS of the use of substances classified as CMR 1A and 1B in cosmetic products should also take into account the exposure to those substances of vulnerable population groups, such as children under three years of age, elderly people, pregnant and breast-feeding women and persons with compromised immune responses.” The EDQM 2nd edition guidance on safe cosmetic products for young children operationalises this Annex I §3 requirement for the infant/toddler product class.

Article 15 — CMR substances

Article 15(1)-(2): CMR category 1A or 1B substances under CLP Regulation (EC) No 1272/2008 are prohibited in cosmetic products, with a narrow food-safety-based derogation requiring SCCS evaluation. CMR category 2 substances are prohibited unless SCCS-evaluated and found safe. This catches the inorganic-arsenic salts, lead compounds, cadmium compounds, Cr(VI) compounds, Ni-carcinogen compounds and beryllium compounds listed in Annex VI of CLP Reg. 1272/2008 — most of which are also covered explicitly by individual Annex II entries listed above, but Article 15 closes the gap for newly-classified CMR metal compounds without requiring an Annex II amendment.

Penalty and surveillance framework (Articles 22, 25-27, 37)

Member States designate competent authorities for in-market control (Article 22) including documentary review of the cosmetic product safety report / product information file (Article 11), physical and laboratory checks. Articles 25-27 govern non-compliance, the safeguard clause for products that comply with Annex II/III but still endanger human health, and the provisional-measure mechanism. Article 37 requires Member States to lay down “effective, proportionate and dissuasive” penalties for infringements. The regulation does not set EU-level fine amounts; penalty levels are national.

Repeal and transitional dates (Articles 38-40)

  • Entered into force: 11 January 2010 (twentieth day after OJ publication on 22 December 2009).
  • General date of application: 11 July 2013.
  • Article 15(1) and (2) (CMR prohibitions) applied from 1 December 2010.
  • Article 16(3) second subparagraph (nanomaterial notification grandfather provision) applied from 11 January 2013.
  • Directive 76/768/EEC was repealed with effect from 11 July 2013 (except Article 4b, repealed 1 December 2010).

Annex VI mineral UV filters (point-in-time text, 31 December 2020)

Annex VI entries for the two mineral UV filters were checked against the legislation.gov.uk point-in-time copy of Annex VI as it stood on 31 December 2020 (PDF pp. 3-4 of that copy). The current consolidated EUR-Lex text was not obtained, so later amendments may not be reflected.

  • Entry 27, titanium dioxide: maximum 25 % in the ready-for-use preparation; the combined total of titanium dioxide and titanium dioxide (nano) may not exceed 25 %. For colourant use, Annex IV No 143 applies.
  • Entry 27a, titanium dioxide (nano): maximum 25 %; not to be used in applications that may lead to exposure of the end user’s lungs by inhalation; only nanomaterials with purity ≥ 99 %, rutile form or rutile with up to 5 % anatase, median particle size by number ≥ 30 nm, aspect ratio 1 to 4.5, volume specific surface area ≤ 460 m2/cm3, listed coatings (including three coating combinations), photocatalytic activity ≤ 10 % of the uncoated reference, and photostable in the formulation.
  • Entry 30, zinc oxide: maximum 25 %; not in applications that may lead to lung exposure by inhalation; the combined total with the nano form may not exceed 25 %.
  • Entry 30a, zinc oxide (nano): maximum 25 %; not for inhalation applications; purity ≥ 96 %, wurtzite, impurities consisting only of carbon dioxide and water with any other impurities less than 1 % in total; D50 > 30 nm and D1 > 20 nm; water solubility < 50 mg/L; uncoated or coated with the listed silanes or dimethicone.

Annex VI sets purity and total-impurity conditions for the nano forms but no element-specific lead, cadmium, arsenic or mercury limits. Trace metal impurities in mineral sunscreens fall under Article 17 and national technically avoidable values such as the German BVL figures (Technically avoidable heavy metal contents in cosmetic products). The conditions for entry 30a follow the SCCS 2014 addendum (Addendum to the Opinion SCCS/1489/12 on Zinc oxide (nano form), COLIPA S 76 (SCCS/1518/13)).

Routing rationale

This is a horizontal regulation; it touches every cosmetic product placed on the EU market. The products: list is restricted to the slugs the regulation specifically addresses through Annex III conditional permissions, Annex V mercury-preservative permissions, and the Annex I §3 children-under-three safety-assessment requirement. The matrix slug cosmetic-personal-care carries the horizontal scope. The regulation is not the canonical home for any single ingredient contamination_profile cell — it is the EU-jurisdiction legal baseline that should be referenced from the regulation hub and from every cosmetic-product page’s regulatory-context section.

Metals: the full set covers Annex II prohibitions (Pb, cadmium (Cd), total arsenic (tAs), total mercury (tHg), Sb, chromium (Cr), Be, Se, Tl, plus prohibited Ni/Co salts), Annex III restricted metals where the metal itself is the regulated species (Al and Zr in antiperspirant complexes; Sr in oral products; Se in anti-dandruff shampoos), and the mercury entries in Annex V. inorganic arsenic (iAs)/tAs and methylmercury (MeHg)/tHg are not separately distinguished in this regulation; the Annex II prohibitions are written as “Arsenic and its compounds” and “Mercury and its compounds,” so the page is registered as tAs and tHg per HMI speciation conventions.

Pages updated

  • regulations/eu-1223-2009-cosmetics-regulation — canonical regulation hub for EU 1223/2009 with full annex crosswalk to product-category pages (regulation page not authored in this ingest; routing surfaces the unresolved entry for Karen).

Sources

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