Dept of Pharmaceutics 1st yr Dept of pharmaceutics PDF/PPT

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Dept of Pharmaceutics
1st yr

Dept of pharmaceutics 1


 When making and distributing cosmetic
products, it is important to follow marking
and labelling regulations.

 This involves including important information
about the manufacture of the items as well as
their ingredients.

The following are some important labelling
regulations to keep in mind when shaping
cosmetic items for sale. 2


 All packaging needs to include a list of the
items’ ingredients used to make the cosmetic

 This piece of the label should include a
header titled Ingredients. All of the
ingredients should be listed in descending
order of their weight.

 This is identified when the items are added to
the products 3


 Impurities in any used raw materials do not need
to be listed.

 Additionally, any items used to preparation the
products but not in the final item do not need to
be listed. Solvents used perfumes are also an

 Any ingredient with less than1% concentration
can be listed in any order (after, of course,
ingredients with 1% or more concentration).

 Any colouring items can then be listed after the
other ingredients. 4


 The actual ingredients listed should follow
those located in the International
Nomenclature of Cosmetic Ingredients(INCI)

➢ If no name is included, manufacturers
should include: the chemical name, CTFA
name, European Pharmacopoeia title,
International Non-proprietary Name (INN),
EINECS ID, or colour index number. 5


 All cosmetic labeling should include the
official name of the manufacturer or the EX

 Additionally, regulations state that the full
address of such groups should be listed on
the labels.

 This could be the registered office address
for the manufacturer. 6


 Customers should know what they are

 Thus, regulations state that the function of
the product needs to be clearly expressed on
the labeling.

 If the function of the product is not clear
from the item’s packaging or its design, then
it should be clearly stated. 7


 For documentation’s sake, information about
the item’s production batch needs to be

 This can mean a code is assigned to the
product along with a date, or the company
can include more information. 8


 It is important that cosmetic products are
clearly labelled with Best Before date.

 For example, after 30 months, an item’s
quality may deteriorate. This could mean that
the product no longer meets safety
regulations and should not be used.

 Thus, companies need to mark products with
a specific Best Before date that states when
the product is no longer good to use 9


 The formatting of this date is as follows: Best
Before (date).

 Any information about caring for the product
that affects shelf life should be stated on the

 Some items have a shelf life of more than 30
months but will deteriorate quicker if the
product is opened.

 Regulations today have a visual symbol to
signal this. This image looks like a can with
its lid open 10


 Additional information about added
preservatives and UV filters should be listed
on the labelling.

 This content helps customers make educated
decisions about which cosmetic items to
invest in.

 More information about this is listed in
Schedules 4,6, and 7 of the Official Cosmetics
Labelling Regulations 11


 All labeling needs to be easily legible and
clear. The ingredients list must be in a
language well-suited to the consumer.

 This ingredients list should be on the
packaging or directly on the product’s

 If this isn’t possible, such an ingredients list
can be included on enclosed cards, tags, or
labels. 12


 All other information included on the product should
be in English as well as other languages. The
manufacturer or supplier’s name, batch code and
contact information plus the Best Before date should
be included on the product container and its

 If the cosmetics item is small in size, it is appropriate
for the batch code to be printed only on the

 Customers should be referred to other information on
the container, packaging, or enclosed items. 13


 Cosmetic items made in the UK should have a person
responsible or point person to maintain appropriate
information about the products.

 Such content should be at the registered address
listed on the product and should be easily accessible.

 This information can be requested by a number of
organizations, authorities or in the event of a medical

 Such information should be written in English or the
language understood by the responsible person.

: 14


A responsible person is defined as one of the

 Manufacturer of the cosmetic item
 Manufacturer’s agent
 Individual or group who ordered the

product’s manufacture: i.e. Store brand is
often made by third-party manufacturers

 Individual who supplies the product in the UK
(i.e. if the above list is located outside of the
EC). 15


 Information about the composition of the product
should be on hand. This includes both quantitative
and qualitative information. This is especially
important for any dangerous substances. Information
for perfume compositions should include the name of
such items, supplier name and code number.

 Information about physico-chemical and
microbiological specifications in the product: from
raw materials to the cosmetic item.

 Criteria about the criteria and regulations for purity
and microbiological control Method or procedure for
the manufacture of the cosmetic items. 16


 Safety assessment of health effects of the finished
cosmetic products. Items put on the market after 11th

September 2004 should include additional
information about whether or not children under the
age of three can use the product.

 Title, name, and qualifications of the person who
administered any and all testing and assessments of
the cosmetic products

 Any data that relates to negative effects of a product
on a user’s health. Such information should be easy
to access not only by government groups and the
industry but also by the general public. 17


 Specific evidence that proves a product’s
claims affecting health, beauty, etc.

 All items made and sold after 11th September
2004 should include information animal
testing of any item’s safety, development or
use 18 19