EU Cosmetics Animal Testing Ban

Yes. Great Britain keeps the same two-part ban (on testing and on marketing) in its retained version of Regulation (EC) No 1223/2009, and the wording is stricter than the EU text. GB Article 18 is a flat prohibition. It has no phase-in dates and no "once a validated alternative exists" condition. It does expressly allow historic animal data to be used ^[4]. Breaching it is a criminal offence under the Cosmetic Products Enforcement Regulations 2013 ^[5].

What GB Article 18 says ^[4]

• Art. 18(1), marketing ban: no cosmetic product may be placed on the market if any of the following was tested on animals "in order to meet the requirements of this Regulation":
  • (a) its final formulation; or
  • (b) its ingredients or combinations of ingredients.
• Art. 18(1A), historic data: paragraph 1 "does not prevent the use of historic animal testing data" to meet the Regulation's requirements. The EU Article 18 has no such provision.
• Art. 18(2) and (3), testing ban: no animal testing of finished products, or of ingredients and ingredient combinations, may take place "in the United Kingdom" to meet the Regulation's requirements.

How this differs from the EU text

• No conditions or dates. The EU bans in Article 18(1) depend on alternative methods having been validated, and Article 18(2) sets the 2009 and 2013 deadlines ^[1]. GB Article 18 contains neither: the prohibitions are unconditional.
• No derogation. GB Article 18 has only paragraphs 1, 1A, 2 and 3. There is no route for an exceptional derogation on an existing ingredient like the one in the EU text ^[2].
• Same reach for the marketing ban. As in the EU, the marketing ban applies to testing done "to meet the requirements of this Regulation." Its wording does not depend on where the testing took place. Only the testing ban is limited to testing in the UK.

"Not tested on animals" claims (GB Art. 20(3)) ^[6] The condition matches the EU one. The responsible person may say no animal tests were carried out only if:

• neither the manufacturer nor its suppliers carried out or commissioned animal tests on the finished product, its prototype or any ingredient; and
• no ingredients tested on animals by others for developing new cosmetic products were used.

Enforcement and penalties

• Offence: Regulation 12(1) makes it an offence to breach any provision listed in Schedule 4 ^[5]. Schedule 4 lists Article 18 ("Animal testing requirements") and Article 20 (product claims) ^[7].
• Penalties (Regulation 13(1)) ^[8]:
  • on summary conviction: a fine up to the statutory maximum, up to three months' imprisonment, or both;
  • on indictment: a fine up to £20,000, up to twelve months' imprisonment, or both.

Northern Ireland Under the Windsor Framework, the EU Regulation as it applies in Northern Ireland under the Protocol governs NI. GB Article 5A covers a responsible person established in Northern Ireland who has complied with that EU Regulation, for "qualifying Northern Ireland goods." That person is treated as complying with GB Articles 8, 10 to 12, 14 to 18 (which includes the animal testing article) and 20 to 24, plus the other articles Article 5A lists ^[9].

Approach: I read Articles 5A, 18 and 20 of Regulation (EC) No 1223/2009 as retained in Great Britain (latest revised text on legislation.gov.uk), and the offence and penalty provisions of the Cosmetic Products Enforcement Regulations 2013 (SI 2013/1478). I didn't look at how the ban interacts with testing required under UK REACH. I can do that next if it's useful.

The SCCS accepts validated non-animal methods endpoint by endpoint. In its Notes of Guidance (12th revision, SCCS/1647/22), it also accepts, case by case, methods that are scientifically valid but not fully validated (for example '-omics'), provided there is enough experimental data showing relevance and reliability, including positive and negative controls ^[10]. Validated replacements exist for the local and acute endpoints. For repeated-dose toxicity and reproductive toxicity, and as stand-alone tests for carcinogenicity, there are none yet. Studies must follow GLP and any deviation must be justified ^[10].

What the guidance lists for each endpoint

Endpoint	Accepted non-animal methods	Limits the SCCS notes
Skin corrosion	Rat skin TER (OECD TG 430); reconstructed human epidermis (RhE) (TG 431: EpiSkin, EpiDerm SCT, SkinEthic RHE, epiCS, LabCyte EPI-MODEL24); in vitro membrane barrier test (TG 435, Corrositex) [11][12]	TG 404 (the in vivo test) is no longer allowed for cosmetics [12]
Skin irritation	RhE test (TG 439), either as a stand-alone replacement or inside a tiered strategy. Models: EpiSkin, EpiDerm SIT, SkinEthic RHE, LabCyte, EpiCS, Skin+, KeraSkin [12]	For dyes, colourants and reducing substances, HPLC separation is needed before the MTT readout [12]
Serious eye damage / eye irritation	Eight OECD test guidelines: BCOP (TG 437), ICE (TG 438), STE (TG 491), fluorescein leakage (TG 460), RhCE (TG 492), SkinEthic HCE TTT (TG 492B), Vitrigel-EIT (TG 494), Ocular Irritection (TG 496). Also the defined approaches in TG 467 [13][14][15]	Most cover only part of the range. TG 492B is described as a full replacement for the Draize test, and TG 467 covers Cat. 1, Cat. 2 and No Cat. HET-CAM and the isolated rabbit eye count only as supporting evidence [13][14]
Skin sensitisation	In chemico/in vitro tests: TG 442C (DPRA, ADRA, kDPRA), TG 442D (KeratinoSens, LuSens), TG 442E (h-CLAT, U-SENS, IL-8 Luc). Defined approaches in TG 497: "2 out of 3", ITSv1, ITSv2 [16][17]	A single method cannot stand alone; the SCCS recommends combining them in a defined approach or an IATA [17]. It accepts next-generation risk assessment (NGRA) and defined approaches outside TG 497 only case by case, and asks for OECD reporting format for defined approaches not in TG 497 [18][19]
Phototoxicity	3T3 NRU PT (TG 432) is mandatory as the first tier. If it is positive, RhE phototoxicity (TG 498) is the second tier. The ROS assay (TG 495) is an optional pre-screen [20][21]	No testing is needed if MEC < 1000 L·mol⁻¹·cm⁻¹, or if the substance absorbs only below 313 nm. No validated in vitro method exists for photo-sensitisation [20][21]
Mutagenicity / genotoxicity	The base level is two tests: Ames (TG 471) plus in vitro micronucleus (TG 487). If Ames is not suitable (nanomaterials, biocides, antibiotics), use a mammalian gene mutation test (TG 476 or TG 490) [22][23]	Two clearly negative results mean no further testing is needed [24]. 3D skin comet and RSMN, HET-MN, ToxTracker and transcriptomics are weight-of-evidence (WoE) follow-up tools only. They cannot on their own override a positive result from a recommended test [25]
Acute oral toxicity	3T3 NRU cytotoxicity test (endorsed by EURL ECVAM), only for identifying non-classified substances (LD50 > 2000 mg/kg bw) [26]	The SCCS bases its safety evaluation on (sub)chronic toxicity studies [26]
Acute dermal / inhalation toxicity	No validated non-animal alternative [26][11]	Air-liquid interface lung models are not yet validated [11]
Dermal absorption	In vitro TG 428 combined with the SCCS "Basic Criteria" (SCCS/1358/10). Human skin is preferred, pig skin is the alternative, and at least 8 samples from at least 4 donors are expected [27][28]	Without adequate data, a 50% default absorption is applied. In silico Kp models give only supporting information [28][29]
Toxicokinetics (ADME)	No validated alternatives cover the whole field. Caco-2, hepatocytes and HepaRG are mostly not officially validated [30]
Repeated-dose toxicity	No validated alternative methods yet. NGRA case studies exist (OECD GD 321 caffeine, GD 349 phenoxyethanol) [19]	The SCCS says more trust is needed that NGRA protects health well enough [31]
Reproductive toxicity	No validated method covers the whole reproductive cycle. ESAC judged EST and MicroMass scientifically valid for embryotoxicity categories [32]	These are screening tools only and cannot be used for quantitative risk assessment [32]
Carcinogenicity	No validated in vitro OECD test guideline. Cell transformation assays (BALB/c 3T3, SHE under GD 214, Bhas 42 under GD 231) are pre-validated and usable only within WoE [33][34]	A cell transformation assay cannot establish carcinogenic potential on its own [34]

Rules that apply across endpoints

• Good in vitro practice: in vitro methods should follow the OECD Guidance Document on Good In Vitro Method Practices (GIVIMP, OECD GD 286) ^[29].
• Non-guideline methods: tests with no OECD test guideline should follow OECD GD 211 ^[35].
• In silico tools: QSAR and read-across are supporting evidence. Naming a specific software is not an SCCS endorsement ^[15][36].
• Existing animal data: in vivo data are accepted only if the test was done before the animal testing ban, or was done to comply with other, non-cosmetic legislation such as REACH. The guidance says this for each endpoint, for example reproductive toxicity and carcinogenicity ^[37][34].

Approach: I read the SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, 12th revision: the sections on toxicological tools (3-4) and on dermal absorption. I did not check whether a later revision of the guidance has updated the list.