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I. GENERAL REQUIREMENTS.
A) Location and surroundings. -- The factory shall be located in a sanitary place any hygienic conditions shall be maintained in the premises. Premises shall not be used for residence or be interconnected with residential areas. It shall be well ventilated and clean.
B) Buildings.-- The buildings used for the factory shall be constructed so as to permit production under hygienic conditions and not to permit entry of insects, rodents, files, etc.
The walls of the room in which manufacturing operations are carried out shall be up to a height of six feet from the floor, be smooth, waterproof, and capable of being kept clean. The flooring shall be smooth, even and washable and shall be such as not to permit retention or accumulation of dust.
C) Water - supply .-- The water used in manufacture shall be of portable quality.
D) Disposal of water.-- Suitable arrangements shall be made for disposal of waste water.
E) Health, clothing and sanitary requirements of the staff. -- All workers shall be free from contagious or infectious diseases. They shall be provided with clean uniforms, masks headgears and gloves wherever required. Washings facilities shall also be provided.
F) Medical Services. -- Adequate facilities for first-aid shall be provided.
G) Work - benches shall be provided for carrying out operations such as filling, labelling. packing, etc. Such benches shall be fitted with smooth, imperviosu tops capable of being washed.
H) Adequate facilities shall be provided for washings and drying of glass containers if the same are to be used for packing the product.
II. REQUIREMENTS OF PLANT AND EQUIPMENT.
The following equipment, area and other requirements are recommended for the manufacture of
A) Powders. -- Face-powder, cake make-up, compacts, face-packs, masks and rouges etc.
1. Eauipments :
a) Powder mixer of suitable type provided with a dust collector.
b) Perfume and colour blender.
c) Sifter with sieves of suitable mesh size.
d) Ball mill of suitable grinder.
e) Tryas and scoops (stainless steel).
f) Filling and sealing equipments provided with dust extractor.
g) For compacts :--
(i) a separate mixer, (ii) compact pressing machine.
h) Weighing and measuring devices.
i) Storage tanks.
An area of 15 square metres is recommended. The section is to be provided with adequate exhaust fans.
B) Creams. lotions, emulsions, pastes, cleansing milks, shampoos, pomade, brilliantne, shaving-creams and hair-oils, etc.
a) Mixing and storage tanks of suitable materials.
b) Heating kettle -- steam, gas or electrically heated.
c) Suitable agitator.
d) Colloidal mill or homogeniser (wherever necessary).
e) Triple roller mill (wherever necessary).
f) Filling and sealing equipments.
g) Weighing and measuring devices.
An area of 25 square metres is recommended.
C) Nail Polishes and Nail Lacquers.
1. Equipment :
(a) A suitable mixer.
(b) Storage tanks.
(c) Filling machine - hand operated of power driven.
(d) Weighing and Measuring devices.
An area of 15 square metres is recommended. The section shall be provided with flame proof exhause system.
2. Premises :-- The following are the special requirements related to Nail Polishes and Nail Lacquers.
(a) It shall be situated in an industrial area.
(b) It shall be separate from other cosmetic-manufacturing area by metal/brick parition up to ceiling.
(c) Floors, walls, cellings and doors shall be fireproof.
(d) Smoking, cooking and dwelling shall not be permitted and no naked flame shall be brought in the premises.
(e) All electrical wiring and connections shall be concealed and main electric switch shall be outside the manufacturing area.
(f) All equipment, furniture and light fittings in the section shall be flameproof.
(g) Fire extinguisher like foam and dry powder and sufficient number of buckets containing sand shall be provided.
(h) All doors of the section shall open outwards.
3. Storage. -- All explosive solvents and ingredients shall be stored in metal cupboards or in a separate enclosed area.
4. Manufacture.
(a) Manufacture of lacquer shall not be undertaken unless the above conditions are complied with.
(b) Workers shall be asked to wear shoes with rubber soles in the section.
5. Other requirements :-- No objection certificate from local Fire Brigade Authorities shall be furnished.
D. Lipsticks and Lipgloss, etc.
1. Equipment :
(a) Vertical mixer.
(b) Jacketted kettle -- steam, gas or electrically heated ( )
(c) Mixing vessels (stainless steel).
(d) Triple roller mill/Ball mill.
(e) Moulds with refrigeration facility.
(f) Weighing and measuring devices.
An area of 15 square metres is recommended.
E. Depilatories :
1. Equipment :
(a) Mixing tanks.
(b) Mixer.
(c) Triple roller mill or homogeniser (where necessary).
(d) Filling and sealing equipment.
(e) Weighing and measuring devices.
(f) Moulds (where necessary).
An area of 10 square metres is recommended.
F. Preparations used for Eyes :-- Such preparations shall be manufactured under strict hygienic conditions to ensure that these are safe for use.
1. Eyebrows, Eyelashes, Eyeliners, etc.
1. Equipments :
(a) Mixing tanks.
(b) A suitable mixer.
(c) Homogeniser (where necessary).
(d) Filling and sealing equipment.
(e) Weighing and measuring devices.
An area of 10 square metres is recommended.
2. Kajal and surma.
1. Equipment :
(a) Base steriliser.
(b) Powder steriliser (dry heat oven).
(c) Stainless steel tanks.
(d) A suitable Mixer.
(e) Stainless steel sieves.
(f) Filling and sealing arrangements.
(g) Weighing and measuring devices.
(h) Homogeniser (where necessary).
(i) Pestle and Mortar (for Surma).
An area of 10 square metres with a separate area of 5 square metres for base sterilization is recommended.
Other requirements for 1 and 2 :
(a) False ceiling shall be provided wherever required.
(b) Manufacturing area shall be made flypoof. An airlock or an aircurtain shall be provided.
(c) Base used for Kajal shall be sterilised by heating the bast at 150 degree C for required time in a separate enclosed area.
(d) The vegetable carbon black powder shall be sterilised in a drying oven at 120 degree C for required time.
(e) All utensils used for manufacture shall be of stainless steel and shall be washed with detergent water, antiseptic liquid and again with distilled water.
(f) Containers employed for "Kajal" shall be cleaned properly with bactericidal solution and dried.
(g) Workers shall put on clean overalls and use handgloves wherever necessary.
G. Aerosol :
1. Equipment :
(a) Air-compressor (wherever necessary).
(b) Mixing tanks.
(c) Suitable poprllan filling and crimping equipments.
(d) Liquid filling unit.
(e) Leak testing equipment.
(f) Fire extinguisher (wherever necessary).
(g) Suitable filtration equipment.
(h) Weighing and measuring devices.
An area of 15 square metres is recommended.
2. Other requirements : -- No objection certificate from the Local Fire Brigade Authorities shall be furnished.
H. Alcoholic Fragrance solutions.
Equipment :
(a) Mixing tanks with stirrer.
(b) Filtering equipment.
(c) Filling and sealing equipment.
(d) Weighing and measuring devices.
An area of 15 square metres is recommended.
I. Hair Dyes :
Equipment :
(a) Stainless steel tanks.
(b) Mixer.
(c) Filling unit
(d) Weighing and measuring devices.
(e) Masks, gloves and goggles.
An area of 15 square metres with proper exhaust is recommended.
J. Tooth-powders and toothpastes, etc.
1. Tooth-powder in General.
Equipment :
(a) Weighing and measuring devices.
(b) Dry mixer (powder blender).
(c) Stainless steel sieves.
(d) Powder filling and sealing equipments.
An area of 15 square metres with proper exhaust is recommended.
2. Toothpaste's.
Equipment :
(a) Weighing and measuring devices.
(b) Kettle--steam, gas or electrically heated (where necessary).
(c) Planetary mixer with deaerator system.
(d) Stainless steel tanks.
(e) Tube filling equipment.
(f) Crimping machine.
An additional area of 15 square metres with proper exhaust is recommended.
3. Tooth -- Powder (Black).
Equipment :
(a) Weighing and measuring devices.
(b) Dry mixer powder blender.
(c) Stainless steel sieves.
(d) Powder filling arrangements.
An area of 15 square metres with proper exhaust is recommended. Areas for manufacturing
"Black" and "White" tooth-powders should be separate.
K. Toilet Soaps.
Equipment :
(a) Kettles/pans for saponification.
(b) Boiler or any other suitable heating arrangement.
(c) Suitable stirring arrangement.
(d) Storage tanks or trays.
(e) Driers.
(f) Amalgamator/chipping machine.
(g) Mixer.
(h) Triple roller mill.
(i) Granulator.
(j) Plodder.
(k) Cutter.
(l) Pressing stamping and embossing machine.
(m) Weighing and measuring devices.
A minimum area of 100 square metres is recommended for the small-scale manufacture of toilet soaps.
The area recommended above are for basic manufacturing of different categories of cosmetics. In addition to that separate adequate space for storage of raw materials, finished products, packing materials shall be provided in factory premised. 21aa [ * * * ]
Note No. I : The above requirements of the Schedule are made subject to the modification at the discretion of the Licensing Authority, if he is of the opinion that having regard to the nature and extent of the manufacturing operations it is necessary to relax or alter them in the circumstances of a particular case.
Note No.II : The above requirements do not include requirements of machinery, equipments and premised required for preparation of containers and closures of different categories of cosmetics. The Licensing Authority shall have the discretion to examine the suitability and adequacy of the machinery, equipments and premises for the purpose taking into consideration the requirements of the licensee.
Note No. III : Schedule M-II specifies equipments and space required for certain categories of cosmetics only. There are other cosmetics items, viz. Attars, prefumes,etc., which are not covered in the above categories. The Licensing Authority shall,in respect of such items or categories of cosmetics, have the discretion to examine the adequacy of factory premises, space, plant and machinery and other requisites having regard to the nature and extent of the manufacturing operations involved and direct the license to carry on necessary modification in them.]
SCHEDULE U ( I )
[See Rules 142 and 142-B]
I. PARTICULARS TO BE SHOWN IN THE MANUFACTURING RECORDS.
1. Serial number.
2. Name of the product.
3. Lot/Batch size.
4. Lot/Batch number.
5. Date of commencement of manufacture and date when manufacture was completed.
6. Names of all ingredients, quantities required for the lot/batch size, quantities actually used.
7. Control reference numbers in respect of raw materials used in formulation.
8. Reference to analytical repot number.
9. Actual production and packing particulats indicating thesize and quantityof finished packings.
10. Date of release of finished packing for distribution or sale.
11. Signature of the expert staff responsible for the manufacture.
II. RECORDS OF RAW MATERIALS
Records in respecr of each raw materials shall be maitained indicating the quantity received, control reference number, the quantity issued from time to time, the names and batch numbers of the products for the manufacture of wich the said quantity of raw material has been issued and the particulars relating to the proper disposal of the stocks.
Notes:-(1) the Licensing Authority may permit the licensee to maintain in such manner as is considered satisfactory, provided the basic requirements laid down above are complied with.
(2) The Licensing Authority may direct the license to maintain records for such additional particulars as it may consider necessary in the circumstances of a particulars case.)
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