Toxic chemicals in cosmetics in India:

need for better legislation

   India   Asia

   Raw materials   Cosmetics

India is one of the world’s largest markets for cosmetics. However, in a

recent study reported in Jan 2014, the Pollution Monitoring Lab (PML) at
India’s Centre for Science and Environment (CSE) found alarming data about
the unregulated use of toxic chemicals in many leading brands of cosmetics,
from both Indian and international companies.
This study was India’s largest investigation on the use of heavy metals in the
cosmetic industry. The Centre for Science and Environment (CSE) took the
initiative and tested 73 cosmetic products tested from four different
categories. The results showed excessive levels of hazardous heavy metals,
including mercury, in half of the products tested.

Results of the investigation:

Samples: 32 fairness creams (skin-whitening creams) were tested for
mercury. 30 lipsticks, 8 lip balms and 3 anti-aging creams were tested for
lead, cadmium, chromium and nickel. The samples included both Indian and
international major cosmetic brands, and some herbal products as well:
 Mercury was found in 44% of the fairness creams tested by CSE, with
concentrations in the range of 0.10 parts per million (ppm) to 1.97 ppm.
 Chromium was found in 50% of the lipsticks tested, in the range of 0.45
ppm to 17.83 ppm.
 Nickel was found in 43% of the lipsticks tested, in the range of 0.57 to
9.18 ppm. CSE did not find any heavy metals in anti-aging creams and lip
balms. It also did not find lead and cadmium in lipsticks.
Health risks from these cosmetics
Clearly, it can be concluded that most of the tested skin-whitening creams
and lipsticks sold in India contain dangerous heavy metals in high
concentrations. However, to estimate the health risk from these chemicals,
their concentration levels need to be compared against the Acceptable Daily
Intake (ADI) limits for that specific chemical as per the regulations.

Unfortunately, India does not have any set limits for ADI of mercury. In this
study, the CSE lab used the ADI set by the US Environmental Protection
Agency (USEPA) to compare against the amount of mercury found in the
cosmetics.
 In the case of mercury, it was found that skin-whitening creams likely
contribute up to 71 per cent of the ADI for mercury, depending upon the
product and the amount of the fairness cream used. This is an excessive
amount of mercury exposure from a single product, and users are likely
to exceed their daily ADI limits as mercury is also present in many other
commonly used sources.
 In case of chromium, the amounts found in lipsticks were very high
compared to the ADI. For a heavy user, 13 out of 30 lipsticks tested by
CSE would cross the ADI. The lipsticks with highest level of chromium
would expose a heavy user to over 15 times the safety limit.

Such high levels of heavy metals make these cosmetics very unsafe for users.
Mercury is a neurotoxin, and is associated with anxiety, depression,
psychosis and peripheral neuropathy. It can also cause kidney damage and
skin problems. Chromium on the other hand is a proven carcinogen, especially
in its hexavalent form that is used in cosmetics.
Current regulations for cosmetics in India:
The three main regulations for Cosmetics products in India are:
 The Drugs and Cosmetics Act 1940, amended in 2008
 The Drugs and Cosmetics Rules 1945
 Labeling Declarations by Bureau of Indian Standards (BIS). BIS only sets
the standards for the products listed under Schedule ‘S’ of the Drugs and
Cosmetics Rules 1945.

Rules 145 D and 135 A of the Drugs and Cosmetics Rules prohibit the
manufacture and import, respectively, of cosmetics containing mercury
compounds.

Rule 145 of the Drugs and Cosmetics Rules prohibits the use of lead and
arsenic compounds in cosmetics as colourants.

Rule 135 of the Drugs and Cosmetics Rules prohibits the import of cosmetics
in which a lead or arsenic compound has been used as a colourant.

The Dyes used in the manufacture of skin creams and lipstick must comply
with IS 4707 (Part I) as per the Schedule Q of Drugs and Cosmetics Act and
Rules. Other ingredients are required to comply with IS 4707 (Part 2).

Rule 134 of Drugs and Cosmetics Rules restricts the use of Dyes, Colors and
Pigments other than those specified by the Bureau of Indian Standards (IS:
4707 Part 1 as amended) and Schedule Q. It also indicates the permissible
limits for Synthetic Organic Colors and Natural Organic Colors used in the
cosmetics as below
 2 ppm of Arsenic (from Arsenic
Trioxide).
 20 ppm of lead.
 100 ppm of total heavy metals other
than lead.

Bureau of Indian Standards (BIS) has provided the specifications for Skin
Creams and Lipsticks in the Indian Standards (IS) 6608:2004 and 9875:1990
respectively.

Regrettably, the IS 6608:2004 states that if all the raw materials have been
tested for heavy metals and comply with the requirements, then the
manufacturer need not test the finished cosmetic for heavy metals and
arsenic. This regulatory loophole is probably why the finished products are
not tested and heavy metals are found widespread in the cosmetics industry.
Weak regulatory control and major gaps in legislation
Industry experts and CSE team leaders state that the regulatory control over
the cosmetics industry in India is extremely weak and ineffective.
 Limits are set only for a few heavy metals in the colourants category.
 There are no limits for many other heavy metals, or common heavy
metals in other categories besides colourants.
 There are no set limits for finished products
 Most worryingly, none of the finished products are tested by regulators.
 Finally, there is no government or state level organization specifically
assigned or empowered to enforce the available regulations.

There are a few steps in the right direction from the Indian government
regarding the cosmetics industry. The Drugs and Cosmetics Bill, 2013 , was
released recently to replace the earlier and outdated version from 1940,
revised in 2008. The amended bill aims to bring a comprehensive legislation
to cover various aspects of drugs and cosmetics.
India has also introduced a draft notification and a soon-to-be-
implemented legislative rule which will ban animal testing in all its domestic
manufactured and imported cosmetics.