Cosmetics Include Heavy Metals: Laws Related To It Around The World
Cosmetics Include Heavy Metals: Laws Related To It Around The World
Cosmetics Include Heavy Metals: Laws Related To It Around The World
Best Citation - ANJANAH G J, COSMETICS INCLUDE HEAVY METALS: LAWS RELATED TO IT AROUND THE
WORLD, Indian Journal of Legal Review (IJLR), 3 (2) of 2023, Pg. 71-77, APIS – 3920 – 0001 & ISSN - 2583-
2344.
ABSTRACT
Keywords: Cosmetics Product, Heavy Metal, Drug and Cosmetics Act, 1940, ppm (parts per million),
Coloring Agent
153 (Kim et al., 2015, Bocca et al., 2014, Senesse et al., 2004, Agoramoorthy et al., 2008, Al Amry et al., 2011, Smith et al., 2015) and also in “Evaluation of heavy
metals in cosmetic products and their health risk assessment” by Hamna Arshad, Moniba Zahid Mehmood, Munir Hussain Shah, and Arshad Mehmood Abbasi
(https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7335825/) (visited on 24.03.2023)
154 Centre for Science and Environment (CSE) is a not-for-profit public interest research and advocacy organisation based in New Delhi, India. Established in 1980,
CSE works as a think tank on environment-development issues in India, poor planning, climate shifts devastating India's Sundarbans and advocates for policy
changes and better implementation of the already existing policies. https://www.cseindia.org/ (Visited on 22.03.2023)
155 Heavy Metals in Cosmetics, Investigators: Mr. Ramakant Sahu, Ms. Poornima Saxena and Dr. Sapna Johnson; PML/PR-45/2014
(https://cdn.cseindia.org/userfiles/Heavy_Metals_in_Cosmetics_Report.pdf) (Visited on: 26.03.2023)
region (Northern Spain) J Environ Monit. 2010;12(7):1451–1458. & Pacyna evaluation, and treatment. Alternative Medicine Review. 2006;11:2-22;
JM. Monitoring and assessment of metal contaminants in the air. In: Chang Ayenimo JG, Yusuf AM, Adekunle AS, Makinde OW. Heavy metal exposure
LW, Magos L, Suzuli T, editors. Toxicology of Metals. Boca Raton, FL: CRC from personal care products. Bulletin of Environmental Contamination and
Press; 1996. pp. 9–28. Toxicology. 2010
(Ni), arsenic (As), lead (Pb) and mercury (Hg). 163 nephrotoxic165 (kidney), neurotoxic166 (nervous
These heavy metals can be found in natural system) and hepatotoxic167 (liver) in nature and
sources as well as non-natural sources. For may also affect the reproductive system 168.
instance, some of these elements could be Specifically, cadmium affects the skeletal,
found in honey, olive oil, argan oil and some respiratory, reproductive, metabolic and renal
other essential oils. systems of the human body. Studies also show
that it has a connection to provoking lung
The use of cosmetics can be differentiated
cancer, kidney damage and also diabetes.
under three heads based on the time they
Nickel is used in many beauty products like
remain in contact with the human body. The
lipsticks, mascaras, eye shadows, eyebrow
first one is those in contact with the body for a
pencils and even face washes and creams 169.
short span of time like face wash, shampoos,
The side effect of usage of the products in and
scrubs etc. They require rinsing and will be
around the face areas is a likelihood of chronic
washed off soon after application. The second
dermatitis. Mercury is one of the frequently used
type is the process of application, which later
heavy metals during the formulation of these
needs to be allowed to absorb things like body
beauty products. The shiny, silvery and dense
lotion, make-up products etc. Lastly, some
liquid texture of mercury helps make skin-
products like hair colors, nail polish etc. remain
lightening creams.
in contact with the body for an extended
duration. Other ways through which heavy According to a study published on Contact
metals gain entry into the human body are oral Dermatitis, out of 88 eye shadow colors from
ingestion of these cosmetic products. This could various brands, 75% of them contained >5ppm
be the application of some products on the lips (parts per million) of at least one of these heavy
like lip balms, gloss, lipstick, concealer or lip metals - lead, cobalt, nickel and arsenic170. A
pencil. The transmission of heavy metals can study conducted by the Campaign for Safe
also take place through the buccal cavity with Cosmetics in the US showed that 61% of the 33
the usage of toothpaste, breath sprays and different brands of lipsticks had lead up to the
mouthwashes. According to several levels of 0.65 ppm171. Another study by the United
suggestions from studies , the concentration
164
States Food and Drug Administration (FDA) also
of heavy metals like lead, mercury and found that the lead in the lipstick samples had
cadmium is higher in the consumers of topical contamination levels ranging from 0.09 to 3.06
cosmetics than those who do not use the same. ppm172. A study by WHO on the usage of skin-
Issues by Abdul Kader Mohiuddin Published on August 20, 2019 and Heavy chromium and cobalt in consumer products: revisiting safe levels in the new
Metals in Cosmetics: Tamara Attard and Everaldo Attard on millennium. Contact Dermatitis and Smith, V., Clark, S., Wilkinson, M., 2015.
https://www.intechopen.com/chapters/80103 (published on Januray 19th Allergic contact dermatitis in children: trends in allergens, 10 years on. A
2022) retrospective study of 500 children tested between 2005 and 2014 in one
164 European Parliament and Council of the European. Regulation (EC) No Ukcentre
1223/2009 of 30 November 2009 on cosmetic products. Official Journal of 171 Lead in Lipstick. Retrieved October 28, 2010, from
the European Union. 2009;L342:59-209; Roman A, Madras-Majewska B, http://www.safecosmetics.org/article.php?id=223
Popiela-Pleban E. Comparative study of selected toxic elements in propolis 172 Lipstick and Lead: Questions and Answers. Retrieved October 28, 2010,
lightening creams, soaps and lotions in Asia organic colors and natural organic colors
and Central Africa shows that there is use of during the production of Cosmetics. The rule 178
mercury in such products which causes anxiety, has the following ceiling for the use of heavy
depression, skin infection, nerve damage and metals:
mild memory loss in cases of excessive use. 173 A
a. 2 ppm of Arsenic when calculated as
study done by the California Department of
Arsenic Trioxide
Public Health published an investigation report
b. 20 ppm of lead when calculated as lead
on the excessive use of mercury in an unlabeled
c. 100 ppm of heavy metals apart from
face cream that claimed to dull freckles and
lead when calculated as the total of the
age spots, brighten the face and treat acne
respective metals.
containing 5.6 ppm of mercury in it.174
According to Sections 10179 and 10 A180 of the
V. LAWS RELATED TO COSMETICS IN INDIA rules which delegates the power to the Central
Government if satisfied, by notification from
Cosmetic products in India are mostly governed
time to time placing consideration upon public
by the Drug and Cosmetics Act, of 1940, Rules of
welfare, may prohibit the import of certain
1945175 and Labeling Declarations by Bureau of
cosmetics. Section 26 A181 gives power to the
Indian Standards of India (BIS). The Bureau of
Central Government to prohibit the
Indian Standards sets up the standards for
manufacturing of certain cosmetics when such
cosmetic and personal healthcare products
product is dangerous or risks the life of any
under Schedule ‘S’ of the Act.
human being or animal. According to Rule 129
The Bureau of Indian Standards provides Indian G182, cosmetics that are being imported shall be
Standards (IS) for cosmetic and healthcare in conformity with the specifications mentioned
products like skin creams and lipsticks with under Schedule S and Schedule Q. Rule 145 183 of
specifications of the products with numbers like the Act prohibits the use of arsenic and lead as
6608:2004 and 9875:1990 respectively . The Act 176 coloring agents in cosmetic products. Rule 145
further mandates the manufacturer under Rule D184 prohibits the manufacturing of cosmetic
134177 of the Drugs and Cosmetics Rules that the products with the composition of mercury or
dyes, colors and pigments used in the cosmetic through its synonyms like mercurous chloride,
products shall comply with the IS 4707 Part I in mercuric, mercurio, and calomel. Further, Rule
accordance with Schedule Q of the Drugs and 135185 prohibits the import of cosmetics and care
Cosmetics Act and Rules. The other ingredients products containing lead and arsenic
used in the cosmetics shall comply with IS 4707 compounds which have been used as coloring
Part II. These rules are flexible and the
Government may, as and when required as the
market processes amend the IS. The rules also
178 134: Cosmetic to contain Dyes, Colors and Pigments of The Drugs and
Cosmetics Rules, 1945 (As amended up to 31st December, 2016)
lay down the parts per million of these heavy 179 Section 10: Prohibition of import of certain drugs or cosmetics; The Drugs
cosmetics in public interest.; The Drugs and Cosmetics Act, 1940 (As
amended up to 31st December, 2016)
181 Section 26 A: Power of Central Government to prohibit manufacture, etc.,
http://www.fda.gov/Cosmetics/ProductandIngredientSafety/ProductInform of drug and cosmetic in public interest.; The Drugs and Cosmetics Act, 1940
ation/ucm137224.html (As amended up to 31st December, 2016); Ins. by Act 68 of 1982, s. 21 (w.e.f.
173 Mercury in skin lightening products: 1-2-1983)
http://www.who.int/ipcs/assessment/public_health/mercury_flyer.pdf 182 129 G: Standard for imported cosmetics.; The Drugs and Cosmetics Rules,
174 Liu S., Hammond S. K., Rojas-Cheatham A.; Concentrations and Potential 1945 (As amended up to 31st December, 2016)
Health Risks of Metals in Lip Products. Environmental Health Perspectives 183 145: Use of Lead and Arsenic compounds for the purpose of coloring
2013 cosmetics prohibited.; The Drugs and Cosmetics Rules, 1945 (As amended
175 The Drugs and Cosmetics Rules, 1945 (As amended up to 31st December, up to 31st December, 2016)
2016) 184 145: Prohibition of manufacture of cosmetics containing mercury
176 Indian Standards Referred in Government Regulations compounds.; The Drugs and Cosmetics Rules, 1945 (As amended up to 31st
https://www.bis.gov.in/standards/technical-department/petroleum-coal- December, 2016); Ins. by G.S.R. 1074, dt. 19.8.1978 (w.e.f. 2.9.1978)
and-related-products/indian-standards-referred-in-government-regulations/ 185 135: Import of cosmetic containing Lead or Arsenic compound
(Visited on 28.03.2023) prohibited.; The Drugs and Cosmetics Rules, 1945 (As amended up to 31st
177 Subs. B y G.S.R. 811 (E), dt. 14-11-1994 December, 2016)
agents and Rule 135 A186 prohibits the import of The European Economic Community (EEC)
cosmetics having mercury as a component in Directive of 1977 190
enumerates the purity
them. Rule 134-A 187
prohibits the import of requirement of some of the coloring agents in
cosmetics that contain the compound Article 7 and Annex I191. The maximum
hexachlorophene in them. concentration of these heavy metals as
coloring agents is also mentioned for some
VI. ENACTMENTS RELATED TO HEAVY METALS
agents. These coloring agents are standardized
AROUND THE WORLD
as GRAS – Generally Recognized as Safe.
A. INTERNATIONAL COOPERATION ON COSMETICS Annexure II of Cosmetic Regulations consists of
REGULATION (ICCR) the prohibition of chemicals like Arsenic, Lead
cyanide, human tissue etc.
In this global village, it is the International
Cooperation on Cosmetics Regulation (ICCR)188 C. UNITED KINGDOM
that regulates and discusses the major global
According to the United Kingdom Cosmetic
concern related to cosmetics and personal
Product Regulation (CPR), the presence of a
hygiene care products. This organization is a
small amount of these heavy metals with
voluntary international group of countries such
absence of intention is permissible and such
as Canada, Brazil, Taipei, Japan, the European
product shall be deemed as ‘safe for use’ 192. The
Union, the Republic of Korea and the United
use of heavy metals under this category is
States. The organization started issuing papers
under the blanket of an ‘action limit’ and is
based on the impurities in cosmetic products.
recognized as ‘technically unavoidable in ‘good
Two reports were released by the organization –
manufacturing practice.193’
“Considerations on Acceptable Lead Levels in
Cosmetic Products (Excluding Products Used in D. THE UNITED STATES
the Oral Cavity)” and “Recommendation for
The Federal Food, Drug and Cosmetic Act 194
Acceptable Trace Mercury Levels in Cosmetic
enacted in the United States regulates the
Products”189. With the release of these two
healthcare products and ingredients which are
reports the major concern for the organization
used in making such products. The Act prohibits
was to reduce the contamination of mercury in
the use of any substance which may affect the
the cosmetic products and insisted that
health of the user. The main objective of the Act
mercury should be added in quantities less
is to trace the contamination in the cosmetic
than or equal to 1 ppm.
product on a case-to-case basis. The Food and
B. THE EUROPEAN UNION Drug Administration (FDA) specifies the
regulatory authorities from Brazil, Canada, Chinese Taipei, the European intended presence of a small quantity of a prohibited substance, stemming
Union, Israel, Japan, Republic of Korea, and the United States from impurities of natural or synthetic ingredients, the manufacturing
189 (Excluding Products Used in the Oral Cavity)’ (International Cooperation process, storage, migration from packaging, which is technically unavoidable
on Cosmetics Regulation, 2013) looks at exposure and tolerance to Pb in in good manufacturing practice, shall be permitted provided that such
different ICCR jurisdictions before recommending that ‘trace levels of lead in presence is in conformity with Article 3.
finished cosmetic products (excluding products used in the oral cavity) and 193 Cosmetic products are regulated in the UK by EU retained law Regulation
The second report ‘Recommendation for Acceptable Trace Mercury Levels in (EC) No.1223/2009 (European Union, 2009) setting out the rules on the
Cosmetic Products’ (International Cooperation on Cosmetic Regulation, supply of cosmetic products where the overriding consideration is ensuring
2016) also considered current regulations in different jurisdictions and safe cosmetic products are placed on the UK market and EU member
exposure to Hg; countries. Regulation (EC) No.1223/2009 is a revision of Directive
https://assets.publishing.service.gov.uk/government/uploads/system/uploa 76/768/EEC (European Union, 1976) which was the first regulation to set
ds/attachment_data/file/1142990/heavy-metals-in-cosmetics.pdf A requirements in 1976 for cosmetic products for members of the European
Feasibility Study Investigating Action Limits for Certain Heavy Metal Economic Community (EEC).
Impurities in Cosmetic Product by Office for Product Safety & Standards 194 [As Amended Through P.L. 117–328, Enacted December 29, 2022]
composition of the heavy metals which are heavy metals. arsenic, cadmium, lead and
used as coloring agents like lead, mercury and mercury shall be used in quantities less than 5
arsenic in cosmetic products. Further, the FDA ppm, 20 ppm and 1 ppm respectively.
has set a limit on the use of heavy metals in
VII. CONCLUSION
cosmetic products. For instance, no more than 1
ppm of mercury shall be used in cosmetics that “Looking beautiful”, “You’re Gorgeous”, “Your skin
fall under 21 CFR 700.13. Similarly, it prohibits the is so soft”, who doesn’t want these kinds of
use of zirconium in aerosol products which falls compliments? But aren’t these costing too
under 21 CFR 700.16. much and in some instances may be
someone’s life. It is so contradicting that these
E. CANADA
products come under the category of cosmetic,
Canada governs and regulates the cosmetics personal or self-care, health and hygiene care
and involvement of chemicals through the and not only costs you so much monetary
Canadian Food and Drugs Act , which does not 195
expenses but also ruins your health. The
let a person sell any cosmetic item which question which arises is when there is no health
injures or affects the skin or health of such a in due course of using such cosmetics, then why
user. health care?
The South East Asian countries are governed by Using beauty products is not wrong, but the
the Association of South East Asian Nations quality shall be given much priority along with
(ASEAN) on a global basis . The ten countries
196 the ingredients. The consumer awareness in this
together came up with guidelines for regulating arena shall be important. Ingredients used,
the composition of heavy metals along with composition of the cosmetic, expiry date and all
cosmetic products. The guidelines set limits for related details shall be known to the consumer
because these cosmetics come in contact with
195 Food and Drugs Act R.S.C., 1985, c. F-27 https://laws- semi-permissible human skin and get in
lois.justice.gc.ca/eng/acts/f-27/page-1.html
196 The ASEAN Cosmetic Directive (ACD) is an agreement among ASEAN contact with the organs and the consumer also
countries to harmonize requirements of cosmetic products so as to reduce
technical barriers to trade in the region. The ACD was implemented in has a right to be informed. Hence, cosmetics
Singapore from 1 January 2008.
shall be used with utmost care and in required 8. [ANNEXES OF THE ASEAN COSMETIC
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