The Marketing Ban: Europe Closes Its Market to Animal-Tested Cosmetics

On 11 March 2013 the European Commission announced that the last deadline of a ten-year phase-out had passed. “As of today,” its statement said, “cosmetics tested on animals cannot be marketed any more in the EU.”^[1]

It ended a long argument in Europe and began another: what a market can demand of tests done outside it, for other markets.

The timetable had been set a decade earlier. Directive 2003/15/EC wrote provisions on animal testing into the Cosmetics Directive, 76/768/EEC, and they came into force in stages. Testing finished cosmetic products on animals was prohibited in the Union from 2004, and testing their ingredients from 2009; from March 2009 it was also prohibited to market cosmetics containing ingredients that had been tested on animals.^[2]

One exception remained. For the most complex effects on human health — repeated-dose toxicity, including skin sensitisation and carcinogenicity, reproductive toxicity and toxicokinetics — the deadline for the marketing ban was put back to 11 March 2013.^[2] Until then companies could still carry out those tests outside the Union and rely on the results for a safety assessment inside it. After it, they could not.^[3] Four months later the Directive itself gave way to the Cosmetics Regulation, No 1223/2009.^[3]

The Commission’s own figures show the testing ban working inside Europe before the marketing ban was complete. In 2004, 8,988 animals were reported as used for cosmetic purposes in the Union; in 2008, 1,510; in 2009, 344. They were rats, mice, guinea-pigs and rabbits.^[4]

The same document was frank about where the testing had gone. Any animal testing done for EU cosmetic purposes after 2009 was done outside the EU, and the Commission estimated that between 15,000 and 27,000 animals a year were used abroad for the purpose.^[4] The 2013 deadline was aimed at that remainder.

The Commission did not claim that the science was finished. Full replacement of animal testing by alternative methods, it said, was “not yet possible”.^[6] Reconstructed human skin models could already show whether an ingredient irritated the skin, but for the complex effects on the whole organism replacement would not come from swapping one animal test for one test in a dish.^[7] The Commission had put about EUR 238 million into research on alternatives between 2007 and 2011, and it and the cosmetics industry were each contributing EUR 25 million to SEURAT-1, a programme on repeated-dose toxicity.^[7]

The practical consequence was stated plainly. Products already on the market, with their safety established, could stay, and historic animal data could still be relied on. But where a conclusive safety assessment could not be made without new animal data, the ingredient should not be used.^[7]

China, where testing had been mandatory, moved the following year. From 30 June 2014 animal testing became optional for ordinary, non-special-use cosmetics made in the country, a category that covered products for skin, hair and nails, makeup and perfume; domestic manufacturers could substantiate safety with existing data or with validated non-animal tests instead.^[8] Qi Liubin, who directed the cosmetics division of the China Food and Drug Administration, told state television that it was the first time the regulations had stated clearly that such products could avoid animal testing.^[8]

Imports were not covered. Every imported cosmetic still had to be tested, and Lush said that it and other cruelty-free companies remained unable to trade in China.^[8] Urban Decay had already withdrawn from the Chinese market over the same policy in 2012.^[9] And the relaxation carried a cost that the trade press noted at the time: lighter checks before sale meant more spot checks after it, which would themselves require animal tests.^[8]

The question the 2013 deadline left open reached the EU’s Court of Justice. Three members of the European Federation for Cosmetic Ingredients had tested ingredients on animals outside the EU so that products containing them could be sold in China and Japan, and the federation asked the British courts whether those companies would face criminal penalties for selling the products in Britain.^[10]

On 21 September 2016 the Court gave its answer. EU law, it held, makes no distinction according to where a test was carried out, and the ban’s purpose would be seriously compromised if it could be avoided by testing in third countries: such products may be barred from the EU market if data from those tests is used to prove their safety there. It added one limit — the prohibition applies only to tests carried out after the relevant deadlines.^[10]

The numbers in this story are estimates, and the Commission said so. The count of animals used abroad was a range, 15,000 to 27,000 a year, and the impact of the ban on the industry was, in the Commission’s words, difficult to quantify.^[11] An animal-protection group’s estimate that China’s change could spare 10,000 animals a year assumed that every eligible company used it; how many did is not recorded in any source used here.^[12]

Nor did the ban end the testing of cosmetic ingredients. Most of them are also used in medicines, detergents, food and paints, and may be tested under the laws for those products. What the ban settled was narrower: in Europe, the cosmetic use of an ingredient could no longer be the reason for a new animal test.^[11]