Page 9 - HPIC E-Magazine (January-2021)

Indian News

NEW RULES NOTIFIED
Government overhauls cosmetics regulations

The Health Ministry noti- distribution of which is prohibited
fied the ‘Cosmetics Rules, in the country of origin, can be im-
2020’, on December 15, 2020, ported. Also on the import ban list
with an aim to separately are cosmetics containing hexachloro-
codify and update the rules phene – a chemical preservative
relating to import, manufacture, known for harmful effects on humans.
labelling, sale and distribution Besides, cosmetics tested on animals
of cosmetics in India, which cannot be imported.
were earlier set out under the
Drugs and Cosmetics Rules, ingredient that has not been used Manufacture for sale or distribution
1945 (DCR). anywhere in the world or is not recog- Similar to import and registration
nised for use in cosmetics in any na- of cosmetics, the process for obtain-
To ease the transition, the new tional or international literature’. The ing a manufacturing, sale and dis-
rules require that all licenses grant- new rules mandate importers/manu- tribution license is largely similar
ed under the DCR prior to the com- factures of a ‘new cosmetic’ to make to that under the DCR, albeit with
mencement of the Cosmetics Rules, an application and seek an approval new forms and with reduced statu-
2020, must continue to remain valid from the Central Licensing Authority tory fees. The new rules require that
until the later of (i) their expiry date; (CLA) before such a ‘new cosmetic’ a self-declaration be furnished by
or (ii) a period of 18 months from the could be imported or manufactured in the applicant confirming compliance
date of notification of the Cosmetics India. Such an application should be with good manufacturing practices
Rules, 2020. accompanied with requisite data on and other prescribed requirements.
safety and effectiveness. Further, the In case of manufacturing at more
Ingredients declaration mandatory manufacturer must comply with IS than one premises, separate licenses
It has now become mandatory 4011:2018 standards for testing the should be obtained for each premise.
for manufacturers of cosmetics and safety of the ‘new cosmetic’. Similar to the import registration
make-up products to declare all ingre- certificate, the manufacturing license/
dients, even those with concentra- Import and registration loan license must also remain valid
tion of less than 1%, to help buyers Most of the process of registration in perpetuity, subject to payment of
make more informed choices. and import of cosmetics remains the retention fee before a period of five
same under the new rules, albeit un- years from the date of issue.
Thus far, there was no Central der new forms, and with significantly
law mandating them to declare the reduced statutory fees. The rules Other highlights
full composition of their skin and also streamline applications – the im- Under the new rules, hair dyes
make-up products and licences were porter can make a single license ap- containing para-phenylenediamine
granted without getting detailed plication and seek a single registra- or other dyes, colours and pigments
information. tion certificate for the import of one or should be labelled with specified
more cosmetics manufactured by the warnings. Special provisions have
In order to ensure greater quality same manufacturer in a single manu- been introduced on fluoride content
control of cosmetic products being facturing unit, which also encom- in toothpaste as well – it should not
manufactured, imported and used in passes multiple factories functioning be more than 1,000 ppm and the fluo-
the country, the government has also conjointly. The rules provide that the ride content should be mentioned on
decided to set up the first Central import registration certificate must the tube and carton.
Cosmetics Laboratory and appoint remain valid in perpetuity, subject
inspectors across states. to payment of retention fee before a Also, inspectors will be required
period of five years from the date of to inspect at least once in three years
The new rules, for the first time issue. all premises licensed to manufacture
introduce the concept of a ‘new cos- cosmetics to ensure that the provi-
metic’, which has been defined to According to the new norms, no sions of the Drugs and Cosmetic Act,
mean ‘a cosmetic that contains a novel cosmetic, the manufacture, sale or 1940 and its rules are being fully met.
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