India: End to animal testing of cosmetics and household products
In order to promote the use of validated non-animal research methods, PETA India works cooperatively with national bodies, such as the Bureau of Indian Standards (BIS) and the Indian Ministry of Health and Family Welfare, to reform government testing regulations. PETA India is the only animal rights organization to hold an official seat on both BIS committees that set the precedents for testing the safety of cosmetics and household products: the Cosmetics Sectional Committee (PCD 19) and the Soaps and Other Surface Active Agents Sectional Committee (CHD 25).
A major part of PETA India’s focus has been to encourage the Indian government to follow the progressive examples of the European Union, which has banned animal tests for cosmetics as well as sales of animal-tested cosmetics, and Israel, which has banned testing on animals for both cosmetics and household products as well as selling cosmetics and household products that have been tested on animals. Following extensive efforts by PETA India, substantial progress was made on this issue in 2013 and early 2014.
There are currently three standards for the safety evaluation of cosmetics and household products in India:
- IS 4011: Methods of Test for Safety Evaluation of Cosmetics; requires the skin sensitization test on guinea pig, the acute oral toxicity limit test, and the oral mucosal irritation test on rat
- IS 11601: Methods of Safety Evaluation of Synthetic Detergents – Tests for Skin Irritation and Sensitization Potential of Synthetic Detergents; requires the skin sensitization test on guinea pig
- IS 13424: Safety Evaluation of Bathing Bars and Toilet Soaps – Methods of Test; requires the skin sensitization test on guinea pig
During BIS meetings, PETA India proposed replacing the aforementioned tests with the following non-animal methods:
- Skin Sensitisation Test: Direct Peptide Reactivity Assay (DPRA); Human Cell Line Activation Test (hCLAT); KeratinoSens™; SenCee Tox®; Quantitative structure-activity relationship (QSAR) approach
- Acute Oral Toxicity Limit Test: Balb/c 3T3 neutral red uptake (3T3 NRU) assay; Normal human keratinocyte neutral red uptake (NHK NRU) assay; CeeTox’s (now Cyprotex) AcuteOralTox-LD50 in vitro screen; Novaleads’ EvaTOX assay; QSAR models
- Oral Mucosal Irritation Test; MatTek’s EpiOral tissue model; SkinEthic’s reconstructed human oral epithelium (RHOE) model
The human repeat insult patch test was also proposed as a non-animal method for determining the safety of known chemicals.
At the 23rd meeting of the Cosmetics Sectional Committee (PCD 19) held on June 28, 2013, the Drug Controller General of India (DCGI) decided to delete the requirement of tests on animals from the IS 4011 and to replace them with suitable non-animal methods. He emphasized the need to end animal testing of cosmetics without compromising consumer safety. The DCGI also said that when it is necessary to evaluate cosmetics products in order to exonerate oral toxicity and/or oral mucosal irritation, manufacturers should submit safety data based on non-animal testing methods. During the meeting it was also decided that the following sentence would be included in the standard: “Prior to initiating the test involving novel ingredients or products containing novel ingredients, preliminary safety assessment using Quantitative Risk Assessment (QRA) tools and/or non-animal methods followed by Skin Irritation Test (Patch Test in humans) should be carried out.” The working group in charge of revising the IS 4011 was also asked to submit a quarterly report to the BIS Secretariat documenting the changes that other countries are making with respect to the oral toxicity test.
“The European Union has imposed prohibition of the marketing of the cosmetics and their ingredients which have been tested on animals in March, 2013. In India also, following various representations regarding the ban on use of animals in testing of cosmetics in several countries, the Sectional Committee in its last meeting held on 28th June, 2013 finalized an amendment to delete the requirements for animal based test methods from the standard to align with global practices,” reported the Minister for Health and Family Welfare, Government of India, to the Parliament on December 17, 2013.
In November 2013, at the 65th meeting of the Drugs Technical Advisory Board, which operates under the Ministry of Health and Family Welfare, the Board proposed that a suitable provision be added under the Drugs and Cosmetics Rules, 1945, to prohibit import of cosmetics tested on animals abroad. In January 2014, the Ministry of Health and Family Welfare published a draft notification inviting public comments on the proposed amendment to the Drugs and Cosmetics Rules, 1945: “148-C. Prohibition of testing of cosmetics on animals. – No person shall use any animal for testing of cosmetics.” Later that month, at the 20th meeting of the CHD 25 Committee of the BIS, the DCGI decided to remove the tests on animals from the IS 11601 and the IS 13424 and asked that they be replaced with suitable non-animal methods.
PETA India’s campaign to end testing of cosmetics and household-products in animals has been endorsed by the Animal Welfare Board of India and the Mahatma Gandhi-Doerenkamp Center (MGDC) for Alternatives to Use of Animals in Life Science Education, established in India by the Doerenkamp-Zbinden Foundation. In addition to Member of Parliament Mrs Maneka Gandhi (also Founder, People for Ethical Treatment of Animals – PfA), several other senior politicians also advised the relevant ministries to look into PETA India’s request for an end to these animal tests. President of the Congress Party Mrs Sonia Gandhi, Bharatiya Janata Party leader Shri Lal Krishna Advani, Member of Parliament Shri Abhijit Mukherjee, and the Ministers of State for Health and Family Welfare, Labor and Employment, Agriculture and Food Processing Industries, among others, sent appeals to the Ministries of Health and Family Welfare and Consumer Affairs of the Government of India to consider PETA India’s request. In addition, PETA has held programs to protest testing of cosmetics on animals and push for a ban on sales of animal-tested cosmetics and household products, made a cruelty-free logo available to companies that do not test on animals and started an online database to make it easier for consumers to determine which companies’ products are tested on animals and which are not. The MGDC and caring citizens from all over India also responded to PETA India’s call for appeals to the ministries.
In recognition of PETA India’s work to change government policies regarding animal testing and its efforts to help consumers choose cruelty-free products, international cosmetics company LUSH awarded PETA India its 2012 prize for excellence in lobbying.
PETA India is currently working to persuade the DCGI and the Ministry of Health and Family Welfare to ban the import of cosmetics and household products tested on animals.
Chaitanya Koduri1 and Mohammad A. Akbarsha2
1 People for Ethical Treatment of Animals (PETA) India, Juhu, Mumbai 400049, India;
2 Mahatma Gandhi-Doerenkamp Center, Bharathidasan University, Tiruchirappalli 620024, India
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