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Times Of India
07 january 2013
New Delhi, India.

BSI Revising Standard IS 4011, The Method Of Safety Testing

India in a landmark move is planning to impose a blanket ban on testing cosmetics on animals.

The Bureau of Indian Standards (BSI) is revising the standard IS 4011 – the method of safety testing for cosmetics.

Drug Controller General of India (DCGI) Dr G N Singh told TOI that the Central Drugs Standard Control Organization (CDSCO) is examining the feasibility of banning animal testing of cosmetics.

Dr Singh met MP and animal activist Maneka Gandhi last week to discuss the legislation. Dr Singh said, "Several developed countries have put in rules that ban testing cosmetics on animals. We are thoroughly examining them. We don’t want to be cruel to animals. If other countries don’t allow it, we will also ban animal testing of cosmetics. The decision will follow a through examination and a strong scientific examination."

Gandhi has sent a letter to the DCGI giving scientific evidence supporting a ban on animal testing.

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The letter said, "on a priority, we as a nation need to go cruelty free as far as testing cosmetics are concerned."

Gandhi said that the European Union (EU) has with the 7th amendment of the cosmetic directive prohibited testing of finished cosmetic products from September, 2004.

She also cited that testing cosmetics on animals has also not been required by the US FDA. In spite of this, the BIS standards’ draft includes two painful tests on animals.

"Again the testing and marketing ban on ingredients came into force on March, 2009, in the EU for all human health effects with the exception of three animal tests – repeated dose toxicity, reproductive toxicity and texicokinetics. For these specific health effects the marketing ban will also apply from March 11, 2013, irrespective of the availability of alternative non-animal tests. Hence, testing on animals has become completely illegal in the EU for cosmetics," the letter said.

Gandhi said this is undoubtedly going to affect the country, given the large export market of Indian herbal cosmetics to the EU.

The letter added, "It is important that India acts. Harmonization of India’s regulation with that of Europe’s cosmetics regulation will ensure an immediate upgrade of India’s safety standards in cosmetics testing using nonanimal methods." Gandhi said the DCGI has the power to amend rule 150–A in the Drugs and Cosmetics Rules, 1945, "and the easiest way would be that you amend it to be harmonized with EU cosmetics legislation of November 30, 2009".

The Union health ministry has made it mandatory for the registration of all cosmetics ranging from skin care and hair care products that are imported from April 1, 2013.

The requirement was originally planned to come into force from October 1, 2012. Dr Singh said, "If animal testing of cosmetics isn’t mandatory by either the US FDA or the EU, it seems unnecessary for India to have them at all."

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