2023-03-23T06:24:59
CHAPTER III
IMPORT AND REGISTRATION
12. Import of cosmetics.—(1) No cosmetic shall be imported into India
unless the product has been registered in accordance with these rules by the
Central Licensing Authority or by any officer to whom such powers may be
delegated under sub-rule (1) of rule 5.
(2) An application for registration of a cosmetic product intended to be
imported into India shall be made through the online portal of the Central
Government in Form COS- 1 either by the manufacturer himself or by his
authorised agent or the importer in India or by the subsidiary in India authorised
by the manufacturer.
(3) An authorisation by the manufacturer to his agent in India shall be duly
authenticated either in India before a first class Magistrate or in the country of
origin before the authority competent under the laws of that country or by an
authority specified in the First Schedule.
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(4) The applicant referred to sub-rule (2) above shall furnish along with the
application such other information and documents as specified in Part I of the
Second Schedule:
Provided also that in the event of application for import of bulk finished
formulation ready to fill, the following additional documents shall also required
to be furnished:
(i) a valid manufacturing license for the finished formulation of the
cosmetic ready to fill in finished form from the State Licensing Authority; and
(ii) details of registered brand owner of the finished product in India;
(5) The application for registration in accordance with sub-rule (2) shall be
accompanied by a copy of the receipt of fee having been deposited as specified
in Third Schedule.
(6) The fee shall be such for each category of cosmetic along with each
manufacturing site with additional fee for each category of cosmetic and variant
specified in the Fourth Schedule.
(7) Till such time, the online portal becomes operational for this purpose,
offline application in Form COS- 1 may be made either by the manufacturer
himself or by his authorised agent or by the importer in India or by the
subsidiary in India authorised by the manufacturer for registration of a cosmetic
referred to in sub-rule (1).
(8) The applicant shall be liable to pay testing fees directly to the testing
Laboratory approved by the Central Government referred in rule 11, for
examination, test and analysis of imported cosmetics in respect of cosmetics
identified for such examination as specified in the Fifth Schedule.
(9) The applicant shall pay the fee as specified in the Third Schedule in
connection with the expenditure to be incurred for inspecting or visiting the.1
manufacturing premises of cosmetics approved in the foreign countries by
officers authorised by Central Licensing Authority, as considered necessary.
13. Grant of import registration certificate.—(1) After examination of
documents furnished with the application under sub-rule (2) of rule 12 the
Central Licensing Authority may, on being satisfied, grant import registration
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certificate in Form COS- 2 or may reject such application for which reasons
shall be recorded in writing within a period of six months from the date of
application.
(2) In the event of rejection, the applicant may appeal to the Central
Government within a period of forty-five days and that Government, may, after
such enquiry into the matter, as considered necessary, pass orders in relation
thereto within a period of ninety days from the date of appeal.
(3) In case of a new cosmetic, the applicant shall obtain prior permission in
Form COS- 3 as provided in Chapter V from the Central Licensing Authority
before registration of import of new cosmetic into India.
(4) A single application may be made and a single registration certificate in
Form COS- 2 may be issued in respect of import of one or more cosmetics
manufactured by the same manufacturer:
Provided that the cosmetics are manufactured at one factory or more than
one factory functioning conjointly as a single manufacturing unit for cosmetic
intended for registration.
(5) A fee as specified in the Third Schedule shall be paid for a duplicate
copy of the registration certificate, if the original is defaced, damaged or lost.
14. Validity of import registration certificate.—(1) A registration
certificate granted under rule 13 shall remain valid in perpetuity, subject to
payment of registration certificate retention fee as specified in the Third
Schedule before completion of the period of five years from the date of its issue,
unless, it is suspended or cancelled by the Licensing Authority.
(2) If the licensee fails to pay the required registration certificate retention
fee on or before the due date as referred to in sub-rule (1), the registration
certificate holder shall, in addition to the registration certificate retention fee, be
liable to pay a late fee calculated at the rate of two per cent, of the registration
certificate retention fee for every month or part thereof within one hundred and
eighty days and in the event of non-payment of such fee during that period, the
registration certificate shall be deemed to have been cancelled.
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15. Fresh application in case of change in constitution.—(1) In case of
change in constitution of a registration holder or overseas manufacturer, after
grant of registration under sub-rule (1) of rule 13, an application shall be made
under sub-rule (2) of rule 12 for grant of fresh registration within a period of
one hundred and eighty days from the date of such change in constitution:
Provided that the existing registration shall be deemed to be valid till such
time, fresh registration is issued or application is rejected by the Central
Licensing Authority.
(2) In case of any change in respect of labelling or composition or testing of
registered product or its specifications, the Central Licensing Authority shall be
informed by manufacturer or by the authorised agent or the importer or the
subsidiary in India authorised by the manufacturer within fifteen days along
with an undertaking that products comply with standards laid down by the
Bureau, of Indian Standards as referred in the Ninth Schedule.
(3) In case of change in name or address of a registration holder or overseas
manufacturer, after grant of registration under sub-rule (1) of rule 13, an
application for amendment shall be made in online portal of Central
Government for prior approval from the Central Licensing Authority for the
said changes in registration certificate within a period of sixty days from the
date of such change.
16. Suspension and cancellation of Registration Certificate.—If the
manufacturer or authorised agent or importer fails to comply with any of the
conditions of the Registration Certificate, the Central Licensing Authority may,
after giving him an opportunity to show cause as to why such an order should,
not be passed, by an order in writing, stating the reasons therefore, suspend or
cancel the registration certificate for such period as it thinks fit either wholly or
in respect of some of the cosmetics to which it relates:
Provided that a person who is aggrieved by the order passed by the Central
Licensing Authority may, within thirty days of the receipt of the order, appeal to
the Central Government and that Government may, after such enquiry into the
matter as it considers necessary and after giving the said appellant an
opportunity of being heard, pass such orders as considered appropriate in the
facts and circumstances of the case.
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17. Import of cosmetics already registered for import.—(1) A cosmetic
manufactured in a foreign site and already registered under rule 13 for import
and sale in India, may be imported by any person or entity by making an
application in online portal of the Central Government in Form COS- 4 with an
undertaking as specified in Sixth Schedule.
(2) After examination of documents furnished with the application under
sub-rule (1), the Central Licensing Authority may, on being satisfied, subject to
the conditions, grant import registration number in Form COS- 4A, or may
reject such application for which reasons shall be recorded in writing within a
period of six months from the date of application.
(3) An import registration number granted under sub-rule (2) shall remain
valid for a period of three years from the date of its issue, unless it is suspended
or cancelled.
(4) If the importer fails to comply with any of the conditions of the Import
Registration Number issued in Form COS- 4A, the Central Licensing Authority
may, after giving him an opportunity to show cause as to why such an order
should not be passed, by an order in writing, stating the reasons therefore,
suspend or cancel the import registration number for such period as it thinks, fit.
18. Prohibition of import of certain cosmetic.—(1) No cosmetic, the
manufacture, sale or distribution of which is prohibited in the country of origin,
shall be imported under the same name or under any other name except for the
purpose of examination, test or analysis.
(2) No cosmetics shall be imported unless the "Use Before or use by" date
shown on the label, wrapper or container of the cosmetic is later than six
months from the date of import.
(3) No cosmetic containing hexachlorophene shall be imported.
(4) No cosmetic that has been tested on animals after the 12th day of
November 2014 shall be imported into the country.
19. Documents to be supplied to the Commissioner of Customs.—Before
any cosmetics are imported, a declaration signed by manufacturer or on behalf
of the manufacturer or by importer or on behalf of the importer that the
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cosmetics comply with the provisions of Chapter III of the Act, and the rules
made thereunder, shall be supplied to the Commissioner of Customs.
20. Procedure for import of cosmetics.—(1) If the officer appointed at
the port of entry by the Central Government has reason to believe that any
cosmetic contravenes any of the provisions of the Act or the rules made
thereunder, he may take sample of the cosmetic from the consignment for
inspection.
(2) If on examination of the sample drawn as per sub-rule (1) defects are
noticed, the officer shall advise the Commissioner of Customs about further
action to be taken.
(3) If the suspected contravention of the provisions of the Act or the rules
is such as may have to be determined by test, the officer shall send the sample
to the Laboratory established for the purpose for performing such tests and the
consignment of the said cosmetic shall be detained till such time, the test report
on that sample is received from the Director of the said Laboratory or any other
officer of the Laboratory empowered by him in this behalf:
Provided that if the importer gives an undertaking in writing not to dispose
of the cosmetic without the consent of the Commissioner of Customs and to
return the consignment or such portion thereof as may be required, the
Commissioner of Customs may, make over the consignment to the importer.
(4) If the importer who has given an undertaking under proviso to sub-rule
(1) is required by the Commissioner of Customs to return the consignment or
portion thereof, he shall return the consignment or portion thereof within ten
days of receipt of the notice.
(5) If the Director of the Laboratory established for the purpose by the
Central Government or any other officer of the laboratory empowered by him in
this behalf with the approval of the Central Government, reports to the
Commissioner of Customs or to the officer mentioned in sub-rule (1) that the
sample of any cosmetic in a consignment contravenes provisions of Chapter III
of the Act or rules made thereunder and that the contravention is such that it
cannot be remedied by the importer, the Commissioner of Customs shall
communicate the report forthwith to the importer who shall within two months
of receiving such communication either send back all the cosmetic of that
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description in the consignment to the country in which it was manufactured or
to the country from which it was imported or hand it over to the Central
Government which shall cause it to be destroyed:
Provided that the importer may, within thirty days of receipt of the report,
make a representation against the report to the Commissioner of Customs who
shall forward the representation with a fresh sample of the cosmetic to the
Central Licensing Authority, who shall if necessary, after obtaining the report of
the Director of the Central Cosmetics Laboratory, pass orders thereon which
shall be final.
(6) If the Central Licensing Authority or any other officer empowered by the
said authority in this behalf with the approval of the Central Government,
reports to the Commissioner of Customs after inspection of the sample of the
cosmetic and where necessary, after obtaining a test report thereon, that the
sample of the said cosmetic contravenes any provision of the Act or the rules
made thereunder and that contravention is such that it can be remedied by the
importer, the Commissioner of Customs shall communicate the report forthwith
to the importer and permit him to import the cosmetic on his giving an
undertaking in writing not to dispose of the cosmetic without the permission of
the officer authorised in this behalf by the Central Government.
21. Import of cosmetic for personal use.—Small quantities of cosmetics
the import of which is otherwise prohibited under section 10 of the Act, may be
imported for personal use subject to the following conditions:—
(i) The cosmetics shall form part of a passenger's baggage and shall be the
property of and intended for, the bona fide use of the passenger; and
(ii) The cosmetics shall be declared to the Customs authorities, if thev so
direct.
22. Import through points of entry.—No cosmetic shall be imported into
India except through the points of entry as specified in rule 43A of the Drugs
and Cosmetics Rules, 1945.
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CHAPTER IV
MANUFACTURE OF COSMETICS FOR
SALE OR DISTRIBUTION
23. Application for grant of license or loan license to manufacture
cosmetics for sale or for distribution.—(1) Any person who intends to
manufacture cosmetics shall make an application for grant of a licence or loan
licence to manufacture for sale or for distribution to the state Licensing
Authority.
(2) Application under sub-rule (1) shall be made through an identified
online portal in Form COS- 5 for licence or in Form COS- 6 for loan licence
accompanied with a fee, as specified in the Third Schedule along with
respective documents as specified in Part II of the Second Schedule:
Provided further that till such time the online portal is not operational for this
purpose, offline application in Form COS- 5 for licence or in Form COS- 6 for
loan licence may be made for manufacturing of cosmetic referred to in sub-rule
(2)
(3) In case of a new cosmetic, the applicant shall obtain prior permission in
Form COS- 3 as provided in Chapter V from the Central Licensing Authority
and no licence to manufacture any cosmetic shall be granted by the State
Licensing Authority without such permission.
(4) In addition to the documents specified in part II of the Second
Schedule, the applicant shall furnish a self-declaration in Form COS- 7
conforming compliance with Good Manufacturing Practices, requirements of
premises, plants and equipment for manufacture of cosmetics as specified in the
Seventh Schedule.
(5) On receipt of the application under sub-rule (1) accompanied such fee
and such documents as provided in sub-rule (2) and (3), for grant of a licence or
loan licence, the State Licensing Authority shall grant a licence or loan licence
within a period of forty-five days from the date application after scrutiny of
application and documents it is of the opinion that requirements of the Act and
these rules have been fulfilled:
Provided where the State Licensing Authority considers that the applicant
has not fulfilled the requirement of the Act and these rules, the same shall be
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conveyed to the applicant within forty-five days from the date the application
has been made.
(6) On receipt of the licence or loan licence referred in sub-rule (5), the
applicant may manufacture cosmetics for sale or distribution, after uploading a
copy of such licence on the website of the Central Drugs Standard Control
Organisation.
(7) The State Licensing Authority within thirty days from the date of grant
of licence or loan licence, shall inspect or authorise any other officer
subordinate to such authority to inspect the site and verify the information given
in self certificate in Form COS- 7 referred in sub-rule (4).
(8) Where the State Licensing Authority or any other officer authorised to
do so fails to inspect and verify the site of the licence or loan licence within the
period referred in sub-rule (7), the licence or loan licence shall be deemed to be
valid for all purposes.
(9) In case, it is found at the time of inspection that the self-certificate
contained any false information, the Licensing Authority may, after giving the
licensee an opportunity to show cause, the licence or loan licence may be
cancelled:
Provided that where the State Licensing Authority is of the view that
deficiencies can be removed, the said authority may issue the directions to the
holder of the licence or loan licence to stop the manufacturing till the
requirements are complied with, and when it is complied with, it shall be
informed to Licensing Authority by the applicant and the Licensing Authority if
satisfied may issue the directions to restart the manufacturing within five
working days of receipt of such compliance.
(10) In case, the original license or loan licence is defaced, damaged or
lost; a duplicate copy of the licence or loan licence may be requested for from
the State Licensing Authority on payment of fee as specified in the Third
Schedule.
24. Manufacture at more than one premises.—If cosmetics are
manufactured at more than one premises, a separate application for each of such
premises shall be made and a separate license obtained for each such premises.
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25. Form of license or loan licence to manufacture cosmetics for sale or
distribution.—A license or loan licence to manufacture cosmetics for sale or
distribution shall be granted in Form COS- 8 and loan licence in Form COS- 9.
26. Conditions of license or loan licence for manufacture of
cosmetics.—A license in Form COS- 8 shall be subject to the conditions stated
therein and to the following other conditions, namely:—
(a) Manufacture of cosmetics shall be conducted under the direction and
personal supervision of competent technical staff consisting at least one person
who is a whole-time employee and who possesses any one of the following
qualifications—
(i) holds a Diploma in Pharmacy approved by the Pharmacy Council of India
under the Pharmacy Act, 1948 (8 of 1948), or
(ii) is registered under the Pharmacy Act, 1948 (8 of 1948), or
(iii) has passed the Intermediate Examination with Chemistry as one of the
subjects or an examination recognised by the Licensing Authority as equivalent
to it.
(iv) holds a bachelor degree in Cosmetic Technology from recognized
university.
(b) The factory premises shall comply with the requirements and conditions
specified in the Seventh Schedule.
(c) The manufacturer shall either—
(i) provide and maintain adequate staff, premises and laboratory equipment
for testing the cosmetics manufactured, and the raw materials used for
manufacture in such cosmetics, or
(ii) make arrangements with a laboratory approved by the Central Licensing
Authority under Chapter VIII of the rules and accredited by National
Accreditation Board for Testing & Calibration Laboratories (NABL) for
carrying out such tests.
(d) The applicant shall maintain documentary evidence for the following—
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(i) documents in respect of the ownership or occupation on rental or other
basis of the premises, specified in the application for license or in the license
granted,
(ii) constitution of the firm, or
(iii) any other document that may be required for verifying the correctness of
the statements made by the applicant or the licensee, while applying for or after
obtaining the license as the case may be.
(e) The licensee shall comply with the provisions of the Act and the rules
made thereunder and with such further requirements, if any, as may be specified
in any rules to be made hereafter under Chapter IV of the Act.
(f) The licensee shall keep record of the details of each batch of cosmetic
manufactured by him and of the raw materials used therein as per particulars
specified in the Eighth Schedule and such records shall be retained for a period
of three years after the date of expiry of the batch.
(g) A license in Form COS- 9 shall be deemed to have been cancelled or
suspended, if the license issued, in Form COS- 8, in respect of manufacturing
facilities is cancelled or suspended.
(h) The licensee shall test each batch or lot of the raw materials used for
manufacturing the cosmetics and also each batch of the final product and shall
maintain records or registers showing the particulars in respect of such tests.
The records or registers shall be retained for a period of three years from the
date of manufacture.
(i) The licensee shall allow an Inspector appointed under the Act to enter with
or without prior notice any premises where the manufacture of a substance in
respect of which the license is issued, is carried on, to inspect the premises and
to take samples of the manufactured products for which a receipt shall be issued
in Form COS- 10.
(j) The licensee shall allow an Inspector to inspect all registers and records
maintained under these rules and shall supply to the Inspector such information
as he may have required for the purpose of ascertaining whether the provisions
of the Act and rules made thereunder have been complied with.
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(k) The licensee shall maintain an Inspection book in Form COS- 11 to enable
an Inspector to record his impression and the defects noticed; The manufacturer
shall inform the Licensing Authority within thirty days, in writing, in the event
of change in labelling or composition or testing, or specification or in
documentation of any of the cosmetic pertaining to this license along with an
undertaking that the products comply with standards laid down by the Bureau of
Indian Standards as referred in the Ninth Schedule.
(1) The licensee shall inform the Licensing Authority in writing in the event of
any change in the constitution of the firm operating under the license. Where
any change in the constitution of the firm takes place, the current license shall
be deemed to be valid for a maximum period of six months from the date on
which the change takes place unless, in the meantime, a fresh license has been
taken from the Licensing Authority in the name of the firm with the changed
constitution.
(m) In case of change in name or address of a manufacturer, after grant of
licence or loan licence under sub-rule (5) of rule 23, an application for
amendment shall be made to state Government for prior approval from
Licensing authorities for the said changes in manufacturing license within a
period of sixty days from the date of such change:
Provided that clauses (c) and (d) shall not apply to the manufacture of soap
and the procedure for testing of raw materials and the records to be maintained
by a manufacturer of soap shall be such as are approved by the "Licensing
Authority":
27. Grant or refusal of license.—(1) If the Licensing Authority, after such
further enquiry, if any, as he may consider necessary, is satisfied that the
requirements of the rules under the Act have been complied with and that the
conditions of the license, loan licence and the rules under the Act shall be
observed, he shall grant a license in Form COS- 8 or Form COS- 9 as the case
may be.
(2) If the Licensing Authority is not so satisfied, he shall reject the
application and shall inform the applicant of the reasons for such rejection and
of the conditions which must be satisfied before a license can be granted or
renewed and shall supply the applicant with a copy of inspection report.
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28. Further application for licence or loan licence after rejection.—If
within a period of six months from the rejection of an application for a licence
or loan licence, the applicant informs the State Licensing Authority that the
requirements laid down in the Act and these rules have been fulfilled and
deposits a fee as specified in the Third Schedule, the State Licensing Authority
may, after causing further scrutiny, and on being satisfied that the requirements
for grant of licence or loan licence have been complied with , issue a licence in
Form COS- 8 or Form COS- 9.
29. Appeal to the State Government.—Any person who is aggrieved by
the order passed by the Licensing Authority refusing to grant a license under
this Chapter may within ninety days from the date of receipt of such order,
appeal to the State Government and the State Government may, after such
enquiry as considered necessary, and after giving the said person an opportunity
for representing the case, pass such order as it thinks fit.
30. Validity of licence.—(1) A licence or loan licence issued in Form
COS- 8 or Form COS- 9 shall remain valid in perpetuity, subject to payment of
licence or loan licence retention fee as specified in the Third Schedule before
completion of the period of five years from the date of its issue, unless, it is
suspended or cancelled by the State Licensing Authority.
(2) If the licensee fails to pay the required licence or loan licence retention
fee on or before the due date as referred to in sub-rule (1), the licence or loan
licence holder shall, in addition to the licence or loan licence retention fee, be
liable to pay a late fee calculated at the rate of two per cent, of the licence or
loan licence retention fee for every month or part thereof within one hundred
and eighty days and in the event of non-payment of such fee during that period,
the licence shall be deemed to have been cancelled.
31. Inspection for verification of compliance.—(1) The premises
licensed for manufacturing cosmetics shall be inspected by Inspector appointed
by the Central Government and State Government to verify the compliance with
the conditions of licence and the provisions of the Act and these rules, not less
than once in three years or as needed as per risk based approach.
(2) The inspectors appointed by the Central Government shall, when so
required by the controlling officer or the Central Licensing Authority, carry out
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special inspection of the identified manufacturing facilities for ensuring
compliance with the provisions of this Act and Rules thereunder.
CHAPTER V
PERMISSION FOR IMPORT OR MANUFACTURE OF NEW
COSMETIC
32. Permission for import or manufacture of new cosmetic.—(1) Any
person who intends to import or manufacture a new cosmetic, shall apply to the
Central Licensing Authority in Form COS- 12 along with requisite fee and the
data on safety and effectiveness of cosmetic.
(2) If the Central Licensing Authority, after being satisfied that the
cosmetic if permitted to be manufactured or imported shall be safe and effective
for use in the country, may issue a prior permission in Form COS- 3, subject to
the condition specified therein.
(3) The prior permission obtained in Form COS- 3 shall be furnished along
with the application for import under Chapter III or manufacture under Chapter
IV of such new cosmetics.
(4) Methods of test or analysis to be employed for safety evaluation of new
cosmetic shall be complied by manufacturer as specified in the IS 4011 : 2018
methods of test for safety evaluation of cosmetics, published by the Bureau of
Indian Standards as amended from time to time.
CHAPTER VI
LABELLING, PACKING AND STANDARDS FOR SALE OR
DISTRIBUTION OF COSMETICS
33. Prohibition of sale or distribution. —Subject to the other provisions
of the act and these rules, no person shall sell or distribute any cosmetic unless
the cosmetic, if of Indian origin, is manufactured by a licensed manufacturer
and labelled and packed in accordance with these rules.
34. Manner of labelling.—(1) Subject to other provisions of the rules, a
cosmetic shall carry on both the inner and outer labels:
(a) the name of the cosmetics,
(b) the name of the manufacturer and complete address of the premises
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of the manufacturer where the cosmetic has been manufactured. If the product
has not been manufactured in a factory owned by the manufacturer, the name
and address of the actual manufacturer or the name of the country where it has
actually been manufactured as “Made in........ (name of country)" should be
there on the label:
Provided that if the cosmetic is contained in a very small size container as
30gm or less if the cosmetics are in solid or semi-solid state and 60 ml or less if
the cosmetics is in liquid state, where the address of the manufacturer cannot be
given, the name of the manufacturer and his principal place of manufacture
shall be given along with pin code.
(c) use before or date of expiry (month and year) or use by or expiry date or
expiry XX months from manufactured or date of manufacturing or expiry date.
(2) (a) A distinctive batch number, that is to say, the number by reference to
which details of manufacture of the particular batch from which the substance in
the container is taken are recorded and are available for inspection, the figures
representing the batch number being preceded by the letter "B" or the words
"Batch No." or "B. No." or "Batch" or "Lot No." or "Lot" shall carry on the
inner or outer labels:
Provided that this clause shall not apply to any cosmetic containing 10 grams
or less if the cosmetic is in solid or semi-solid state and 25 milliliters or less if
the cosmetic is in a liquid state:
Provided further that in the case of soaps, instead of the batch number, the
month and year of manufacture of soap shall be given on the label.
(b) Manufacturing licence number, the number being preceded by the letter 'M'
or "M. L. No" or "Mfg. Lie. No." shall carry on the inner or outer labels:
Provided that in case of imported products, if such provision is not mandatory
in country of origin, such cosmetics may be allowed without mentioning
manufacturing license number, subject to fulfilment of other import regulations.
(3) The outer label of the cosmetics shall carry a declaration of the net
contents expressed in terms of weight for solids, fluid measure for liquids, fluid
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measure or weight for semi-solids, combined with numerical count if the
content is sub-divided:
Provided that this statement need not appear in case of a package of perfume,
toilet water or the like, the net content of which does not exceed 60 ml or any
package of solid or semi-solid cosmetic the net content of which does not
exceed 30 grams.
(4) In case of cosmetics; where a hazard exists, every inner label shall
clearly indicate
(a) adequate directions for safe use,
(b) any warning, caution or special direction required to be observed by
the consumer,
(c) a statement indicating the names and quantities of ingredients that
are hazardous or poisonous.
(5) In the case of imported cosmetics to be marketed in India, import
registration certificate number shall be mentioned on the label of unit pack
preceded by letter "RC" or "RC No" or "Reg. Cert. No" along with name and
address of the importer;
(6) Where a package of a cosmetic has only one label, such label shall
contain all the information required to be shown on both the inner and the outer
labels, under these rules.
(7) In all cases, the list of ingredients, present in concentration of more
than one percent, shall be listed in the descending order of weight or volume at
the time they are added, followed by those in concentration of less than or equal
to one percent, in any order, and preceded by the words 'INGREDIENTS':
Provided that this statement need not appear for packs of less than or equal
to 60 ml of liquid and 30 gm of solid and semi-solids.
(8) The cosmetic shall comply with labelling requirement, if any, specified
in the relevant Indian standard as laid down by the 'Bureau of Indian Standards'
for the cosmetics covered under the Ninth Schedule.
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(9) No cosmetic shall be imported unless it is packed and labelled in
conformity with these rules and the label of imported cosmetics shall bear
registration certificate number of the product and the name and address of the
registration certificate holder for marketing the said product in India:
Provided further that in cases where the imported cosmetics require India
specific labelling, the same shall be allowed to be stickered on the unit pack at
the bonded warehouses.
(10) In case, the cosmetic is meant for export then the labels on packages or
container of cosmetic shall meet the specific requirements of law of the country
to which the cosmetic is to be exported, but the following particulars shall
appear in a conspicuous manner on the label of the inner most pack of the
cosmetic in which the cosmetic is packed and every other outer covering in
which the container is packed:—
(a) name of the cosmetic;
(b) the distinctive batch number or lot number or serial number preceded
by the word “Lot No." or "Lot" or "Batch No." or "B. No." or "Serial No." or
"B";
(c) use before or date of expiry, if any;
(d) the name and address of manufacturer and address of actual premises
where the cosmetic has been manufactured;
(e) licence number preceded by letters "Licence No. or Lie. No.";
(f) internationally recognised symbols in lieu of text, wherever required:
Provided that where a cosmetic is required by the consignee to be not
labelled with the name and address of the manufacturer, the labels on packages
or containers shall bear a code number as approved by the state Licensing
Authority.
35. Prohibition against altering inscription on containers, labels or
wrappers of cosmetic. —No person shall alter, obliterate or deface any
inscription or mark made or recorded by the manufacturer on the container,
label or wrapper of any cosmetic:
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Provided that nothing in this rule shall apply to any alteration, inscription or
mark made on the container, label or wrapper of any cosmetic at the instance or
direction or with the permission of the Central Licensing Authority.
36. Prohibition against false or misleading claims.—No cosmetic may
purport or claim to purport or convey any idea which is false or misleading to
the intending user.
37. Labelling of hair dyes containing dyes, colours and pigments.—
Hair dyes containing Paraphenylenediamine or other dyes, colours and pigments
shall be labelled with the following legend in English and local languages and
these shall appear on both the inner and the outer labels:
"Caution.—This product contains ingredients which may cause skin
irritation in certain cases and so a preliminary test according to the
accompanying directions should first be made. This product should not be used
for dyeing the eyelashes or eyebrows; as such a use may cause blindness."
Each package shall also contain instructions in English and local languages on
the following lines for carrying out the test:
"This preparation may cause serious inflammation of the skin in some cases and
so a preliminary test should always be carried out to determine whether or not
special sensitivity exists. To make the test, cleanse a small area of skin behind
the ear or upon the inner surface of the forearm, using either soap and water or
alcohol. Apply a small quantity of the hair dye as prepared for use to the area
and allow it to dry. After twenty-four hours, wash the area gently with soap and
water. If no irritation or inflammation is apparent, it may be assumed that no
hypersensitivity to the dye exists. The test should, however, be carried out
before each and every application.
This preparation should on no account be used for dyeing eyebrows or
eyelashes as severe inflammation of the eye or even blindness may result."
38. Special provisions relating to toothpaste containing fluoride.—
(i) Fluoride content in toothpaste shall not be more than 1000 ppm and
the content of fluoride in terms of ppm shall be mentioned on the tube and
carton.
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(ii) Date of expiry should be mentioned on tube and carton.
39. Standards of cosmetics.—(1) No cosmetic shall be imported or
manufactured unless it complies with the specifications prescribed under the
Ninth Schedule or any other standards of quality and safety, applicable to it, and
other provisions under the rules. In case, the cosmetic is not included under the
Ninth Schedule, it shall meet the requirements under these rules and
specifications and standards applicable to it in the country of origin.
(2) Raw materials specified in ANNEX A of the Indian Standard IS: 4707
Part 2, as amended from time to time, shall not be added in the cosmetic
product.
(3) No Cosmetic shall be imported or manufactured which contains Dyes,
Colours and Pigments other than the one specified by the Bureau of Indian
Standards (IS: 4707 Part 1 or IS: 4707 Part 2, as amended) and included the
Tenth Schedule.
The permitted Synthetic Organic colours and Natural Organic Colours used
in the Cosmetic shall not contain more than:—
(i) 2 parts per million of Arsenic calculated as Arsenic Trioxide.
(ii) 20 parts per million of lead calculated as lead.
(iii) 100 parts per million of Heavy Metals other than lead calculated as;
the total of the respective metals.
(4) No cosmetic containing hexachlorophene shall be manufactured:
Provided that in case of soaps, hexachlorophene may be used in
concentrations not exceeding one per cent weight by weight:
Provided further that the following cautionary note shall be printed and shall
appear in a conspicuous manner on the wrapper of package of each soap,
namely. "Contains hexachlorophene - not to be used on babies".
(5) Cosmetics imported or manufactured in the country shall contain
mercury in the following proportions, namely, —
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(a) in cosmetics intended for use only in the area of eye, the level of mercury
not exceeding seventy parts per million (0.007 per cent.) of mercury, calculated
as the metal, as a preservative;
(b) in other finished cosmetic products, unintentional mercury shall not exceed
one part per million (1 ppm).".
(6) The use of lead and arsenic compounds for the purpose of colouring
cosmetics is prohibited.
(7) No person shall use any animal for testing of cosmetics.
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