COSMETIC

PACKAGING I
Safety and Compliance
 Safety and Compliance in
Cosmetic Packaging

FOREWORD

Cosmetics represent an exciting business opportunity, due to

minimal regulations and an increasing demand in beauty
product. It's an industry that taps into a wide open terrain of
possibilities for global entrepreneurs. So many businesses
are strangled by regulations that cut against profit. Pierre Gachot, CEO, Desjardin SAS.
Like Beauty and the Beast, cosmetics and regulators live
harmoniously in a stress-free relationship.

Desjardin focuses on quality, safety and compliance while enjoying the latitude for creative and sensible
packaging. As a long time player in the market, the company has helped pave the way for the industry's
constantly evolving development.

A Refreshing Way To Help Society

Safety is one of the most treasured concerns in cosmetics, as it is the manufacturer's responsibility to ensure
that mass produced products do not cause harm to society. Packaging is another crucial part of the
cosmetics industry, since the quality of products must be preserved to avoid degradation, while not posing
risks to consumers.
From the consumer's perspective, cosmetics bring them happiness by making them feel better about their
appearance. Ultimately, offering innovative cosmetics spreads joy to people and their circle of friends. It has a
magical quality like music: it enhances lifestyle and self-esteem.

Quality and Reliability

In order to bring the most value to customers, cosmetic products must deliver both utility and an attractive
appearance. Consumers often consider the package to be part of the product, which is why it needs to be
artistic and pleasing to the eye. The reliability of the product equates with a combination of safety, durability,
sustainability and meeting customer expectations.
Cosmetic products must meet international industry standards, as set by ISO, so that they can consumed
safely. One of the most essential standards to ensure safety is for packaging to preserve freshness. This goal
is accomplished by using air tight packaging and containers that prevent corrosion and exposure to
environmental elements such as mold, heat, chemical reactions and radiation.
In the 21st century, sustainability has expanded the definition of cosmetic quality, since a growing number of
consumers seek eco-friendly solutions. That's why innovative companies often use materials for containers
that can be recycled, such as aluminum and tin.

www.desjardin.fr
Regulatory Compliance

The manufacturing and packaging of cosmetics must be compliant with FDA regulations in the United States
and EU regulations in Europe. It's important for the company to disclose the ingredients on the package and
other vital information about how the product should and shouldn't be used. Other crucial facts that
consumers need to know on the package so that they can make informed decisions include product
identification, contact information, function, storage conditions, weight and expiration date.
Transparency is a huge part of compliance, as every cosmetics company must represent its products
appropriately. The labelling must be easy to read, in plain sight and make sense to the consumer.
Consumers must understand that while pharmaceutical drugs are classified by the FDA as medicine,
cosmetics are not. Regulations that apply to cosmetics mainly relate to packaging and listing of color
additives. Personal care products such as soap are not considered cosmetics. A manufacturer must always
be prepared to allow for FDA inspections and be able to show that its products are safe for human
consumption.

Walking the Road to Success - Together

Desjardin has produced millions of tins over the years, giving the company a deep understanding of
appropriate packaging.
Venturing into cosmetics is for entrepreneurs who believe that beauty adds a spark of optimism to the world.
Like the entertainment industry, it's a way to bring people together by giving them the tools of attraction.
Above all, beauty products inspire sensations that only a handful of industries can deliver.

"Enjoy reading and do not hesitate to contact as, when you

have further ideas, questions or thoughts."
-Pierre Gachot, CEO

www.desjardin.fr
1 Suitable Materials for Cosmetic Containers

2 What Companies should know before launching a

product

3 Cosmetic packaging compliant to ISO 22715

4 Is the Standard ISO 22715 on Cosmetic Packaging

legally binding?

5 What you should know when packaging cosmetics

compliant to EU regulations

6 EC Regulation 1223/2009 on cosmetics

7 What you should know when packaging cosmetics

compliant to FDA regulations

8 Important legal requirements to Cosmetics in the

US-Market

9 Metal packaging of food or cosmetics in the USA -

what is generally recognized as safe?

10 Fair Cosmetic Packaging and Labelling

Suitable Materials for Cosmetic Containers
The cosmetics industry uses a variety of materials in its packaging,
including plastics and metals, with glass being among the oldest
packaging materials. The following information provides details on
material used for cosmetic packaging.

The industrial revolution expanded the use of plastics and metals for
making cosmetic containers such as cans and tubes.
Glass Containers
Sand known as silica is the main ingredient of glass, mixed
with metal oxides, sodium carbonate and other trace ele-
ments. Jars made of glass are popular for packaging emul-
sions, since they provide ease for removal of the product
with the fingers. A key benefit of glass is that it has a
decorative and clean look. The three main types of glass
are borosilicate, treated soda-lime and regular soda-lime.
Each one has unique chemical properties.
Borosilicate glass is more chemically inert than soda-lime
glass, as it contains boron and/or aluminum and zinc. This
glass contains sodium hydroxide, which along with other in-
gredients, trace particles can mix into distilled water within
the glass container after a year of storage. Treated
soda-lime is useful for long periods or storage while regular
soda-lime is more chemical resistant, which is appropriate
for general purpose packaging.
Small thick wall glass jars are used for eye shadow, lip
gloss and cream products. Larger glass jars are used for
foundations, makeup removers, creams and powders.
Amber glass jars are designed for bath and body products
that don't have clear colors. When sodium ions are
reduced, glass becomes a more chemical resistant form of
cosmetic packaging.
Plastic Containers
A wide variety of cosmetic packaging is made from plastic,
due to its convenience and hygienic qualities. Unfortunately,
plastic tends to contribute to a large amount of waste and
once it is opened, products usually must be consumed
immediately. One of the main reasons plastic is such a
popular material is due to its low cost. It's also lightweight,
flexible, unbreakable and durable. On top of that, it's
odorless and has a pleasant appearance.
The main disadvantage to plastic is its physical stability,
making it susceptible to absorption, stress cracking and craz-
ing. Resistance to ink and other chemical substances can
limit its use for certain types of packaging.
The most common type of plastic used in cosmetic
packaging is PP. Other plastics include PET and acrylic
ingredients. Acrylic plastic has the appearance of glass but
doesn't break like glass. From an aesthetic perspective,
plastics can be made in various colors or tints, depending
on the material.
Metal Containers
Cans and tubes are commonly made of metals such as
aluminum or tin. Aluminum protects against germs and is
one of the most recycled materials on the planet. Most
collapsible tubes are made of aluminum, while tin and lead
also make up significant percentages in cosmetic
packaging.
Metals work as unbreakable packaging for the strongest
possible protection of products. They can also protect
products by guarding against moisture or high
temperature. For companies trying to convey an
environmentally-friendly image, metals are highly
recyclable. Another key advantage is that metals can be
made in a variety of shapes and sizes to avoid waste.
Overall, metals are a cost efficient, durable and
sustainable solution. In combination with plastics for
example, metal cosmetic containers offer marketers ex-
clusive design options to target the upper price segment.
Choice of Material
Structural and material decisions determine the most ap-
propriate packaging. The volume of the product affects
size and weight, which affects shipping, storage and cost.
Products that oxidize quickly need air-tight containers.
Material selection is based on the following important
factors:
● type of substance within the container
considerations for decoration, color, capacity
lifespan of the product
● size and weight of the product ability to resist
heat
● physical, chemical and biological aspects of the
product
● type of closure (screw on, crimp on, press on,
roll on, friction)
Conclusion
Packaging embodies the brand's identity and
memorability. Often, the package is already considered
part of the prod- uct by the consumer. Consider the
purposes, advantages and disadvantages of certain
materials. Take into account material performance, such
as durability and sustainability, and how it relates to retail
conditions. Cosmetic products need both attractive and
practical packaging to be successful
What Companies should know before launching a product

Packaging and labelling are two extremely important components to

cosmetic marketing. Not only must manufacturers, marketers and supply
chain vendors all come together to agree on the most efficient type of
containers, they must also be very conscious of government regulations and
industry standards. Here's a simplified summary of what cosmetic startups
can expect.
For a startup in the cosmetics industry, it is vital to be able to sell a product
on a worldwide scale to be able to materialize on on initial investment and
product development cost. Also to benefit from the economies of scale, a
global focus increases the possibility to amortize investments and to reduce
costs per unit.
Meeting Standards and Regulations
Commercial standards are set by the International
Organization for Standardization (ISO). It is advantageous
that commercial cosmetic products, whether they are free
samples or for sale, conform to ISO 22715, which relates to
packaging and labelling. While ISO 22715 is not legally
binding, it is however, the common denominator of most of
the national regulations that apply to the packaging and
labeling of cosmetic products. Country regulators refer to
ISO standards as guidelines to best practices for the
various sectors for which they apply. Often, in order to
comply with a local regulation, an individual, business or
manufacturer must comply with the applicable ISO
standard(s).
In many cases national regulations are more strict than
international standards. Toothpastes and oral rinses,
however, should also comply with ISO 11609 and ISO
16408 in addition to ISO 22715 compliance.
To get a deeper understanding of the legal requirements in
USA and the European Union, please read:
● For the EU: What you should know when
packaging cosmetics compliant to EU regulations
and
● For the USA: What you should know when
packaging cosmetics compliant to FDA regulations
Some requirements apply to primary packaging, while
others apply to secondary packaging. Products must
position required information on their primary and
secondary packaging in an indelible, easy-to-read
language appropriate for the country where it is available
for sale or free distribution. Pre-cautions and warnings must
be printed on primary and secondary packaging.
Role of Cosmetic Containers
● storage of the product
● protection of the product against damage or
deterioration from marketing through consumption
stages
● labelling that describes the function of the product
unless presentation is clear
● listing of nominal content at the time of packaging
according to weight and volume
● tracking of manufacture batch number, date, or any
identifying reference
● precautions and warning statements, when
appropriate
● instructions for how to use, when appropriate
Information Required on Packaging
Cosmetics packaging - what startups should know
before launching a product Essentially, labels must
contain a wide variety of content and safety
disclosures so that consumers know what they are
buying. Anytime packaging obscures product visibility
- whether the package is too small for text to be read
or the product isn't obviously seen - a tag or leaflet
must be added with the appropriate information.
Otherwise, the ingredients of the product, along with
instructions, warnings and contact information must
be clearly displayed on the package. Here is
essential information required to be listed on
packaging:
● name and address of the person responsible
for placing the product on the market
● ingredients over 1% must be listed first in de-
scending order of weight
● ingredients under or equal to 1% must follow
in any order
● perfumes and aromatic compositions can be
listed as one ingredient
● number of units in the pack unless visible to
the consumer
● products containing several color shades
must
Requirements for Primary Packages
Ingredients must be visible to the consumer at the
point of sale. Whenever the lack of this information is
confusing and may lead to inadvertent misuse, it must
be indicated on the primary packaging. Otherwise,
these elements can appear on secondary packaging.
Information that identifies the product may be
indicated on the primary packaging if it is visible
before opening the secondary packaging.
Requirements for Secondary Packages
Secondary packaging contains one or more primary
packages that include any protective materials. The
outermost packaging is considered to be the second-
ary packaging that holds or contains the package at
the point of sale. Ingredients, precautions, warnings,
storage conditions and function of the product all need to
appear only on secondary packaging, unless the
information requires more clarity, which requires a listing on
the primary package.

Business contact information including the person

responsible for putting the product on the market, nominal
content at the time packaging and instructions can appear
on the secondary packaging only. Products in packages of
10 g or 10 ml and below do not require nominal content
information.

Free Samples

Often, opening the cosmetics market for a startup is

related with the distribution free samples to attract initial
customers. Those free samples are also a means for
stores to test whether a product finds positive feedback
among their customer base and consequently, whether the
products are worth distributing.

Free samples have slightly less strict requirements than

the normal for-sales product. Their packaging should at
least inform about name of the person or entity which
distributes the product in the concerned market and
information on the market precautions and risks,
appropriate use (if these instructions are appropriate).

In any case, manufacturers or distributors, placing

samples in the European Union to test out the market
must not forget to give notification of their cosmetic
products via the EU Cosmetic Products Notification Portal
(CPNP)

Conclusion

In addition to the ISO, location-specific regulations may

apply, depending on FDA rules or the corresponding EU
standard. In these regulations, additional requirements are
prescribed which mainly concern health and safety issues.
Other requirements to meet industry standards may apply
to certain packages, depending on size. Information on
product durability should be listed when appropriate. But
following the ISO 22715 will allow to streamline packaging
and labelling activities and thus to reduce effort, cost and
time to market.
Cosmetic packaging compliant to ISO 22715
The ISO 22715 is an international standard for cosmetic packaging.
This post explains why marketers should follow the packaging and
labelling requirements and outlines the important specifications for
cosmetic containers.
Why is the ISO 22715 important
While ISO 22715 is not legally binding, it is however, the
common denominator of most of the national regulations
that apply to the packaging and labeling of cosmetic
products. Country regulators refer to ISO standards as
guidelines to best practices for the various sectors for
which they apply. Often, in order to comply with a local
regulation, an individual, business or manufacturer must
comply with the applicable ISO standard(s).
The following sections shed light on the important points
that need to be considered, when packaging cosmetics
compliant to the ISO 22715.
Primary and Secondary Packaging
Information about the contents within a package need to be
visible to the consumer. The outermost package is consid-
ered secondary packaging. In general, packaging must be
designed to protect the product against damage and
deterioration while it is stored or moved.
Required information On Packaging
● name and address of the entity responsible for
marketing the product
● list of ingredients (1% or more listed first in
descending order, 1% if less listed next in any
order)
● function of the product
● storage conditions, except when clear in
presentation
● nominal content by weight and volume at the
time of packaging
● numbers that identify the product, including
manufacturing date
● instructions on how to use, if appropriate
The information on the primary and secondary packaging
must be positioned to be clearly visible and easy to read. It
lettering must correspond with the country where the
product is distributed. Certain information may only need
to appear on the secondary packaging as long as it's
visible to the consumer at the time of purchase.
The only time it's necessary to make sure information
on how to use the product is on the primary packaging
is when it may not be clear from simple instructions.
Names and addresses may be abbreviated in ways
that are clear what they stand for. In some cases,
durability of the product should be listed.
Size and Weight
Small packages less than 15 grams or more than 10
grams need to carry certain information. It must
include the name and address of the manufacturer. It
must also include storage conditions, if appropriate, in
weight or volume. In some cases, units may be used,
if justified. Precautions, warnings and instructions
must also be listed, if appropriate. This information,
except for function of the product (which can be listed
only on secondary packaging), must be listed on the
primary and secondary packaging.
Packages that weigh 10 grams and under do not need
this information. Other exceptions are when labelling is
impracticable due to small size. In such cases the infor-
mation must be included on an attachment, such as a
tag or leaflet. Single packs may also meet this
standard.
Product Use
Some products, due to being on the market for de-
cades, do not require much explanation on how to use
it. In cases where misuse can cause harm to the con-
sumer, however, information must be stated on
packaging. It should also give instructions on steps to
take if by chance the product is misused.
New products that are not widely known need clear in-
structions that eliminate confusion. The marketer must
alert consumers about any possible risks a product
may present.
Conclusion
Cosmetic manufacturers and marketers must have a
clear and thorough understanding of international
standards set in ISO 22715 as a first step towards
compliance with national regulations. In many cases,
product information must be legible and clearly
displayed on both primary and second packaging,
although there are certain exceptions. In general,
labels must identify the ingredients of the product and
where the company is based.

The purpose of setting these standards is to make sure

products are safe before they appear on the market.
Product labels must also conform to standards that
make it clear how to contact the marketer if someone
has an issue with the product. It should also be
obvious for the labelling what constitutes normal use.
Is the Standard ISO 22715 on Cosmetic Packaging
legally binding?

There is a need to maintain a certain level of standards in regards to the

manufacturing and packaging of many products that are used in the home or
for business. The ISO 22715 standardizes the packaging of cosmetics on a
worldwide scale.

The International Organization for Standardization (ISO) formed in 1947, is a

non-governmental organization based in Geneva that continually creates
new standards and updates older ones as needed. This organization has
162 members and represents the interest of international standards in 196
countries thus covering approximately 97 percent of the world’s population.
Since May 2016, there are currently over 21,500 ISO standards in existence.

ISO standards are used to help form public policies and business objectives
that benefit the public. The organization develops new standards as
requested when sectors and their stakeholders determine that a need exists.
ISO oversees technical committees consisting of other NGOs,
representatives from government agencies, consumer organizations, testing
laboratories, and academics. The ISO maintains copyright to the standards
that are developed by these technical committees. The organization also
maintains an interest in intellectual property protection.
What is Standard ISO 22715?
Is the standard ISO 22715 on cosmetic packaging legally
binding?ISO 22715 provides specifications for the
packaging and labeling of all cosmetic products that are
sold or distributed at no charge; i.e. free samples. What is
considered a cosmetic product is regulated through
national regulations. In some cases, national regulations
regarding cosmetic products can be stricter than those
laid out in ISO 22715.
According to ISO 22715, packaging for cosmetics must
be designed according to the specifications provided by
the manufacturer to product the product from damage
during storage, transport and handling. The packaging
should also protect the product from deterioration and
other conditions that could cause an adverse effect on it.
Specifications for labeling cosmetic packaging are also
provided with ISO 22715. These specifications include:
● What information should appear on the
packaging, such as:
➢ Product manufacturer’s name and
address
➢ List of ingredients in descending order
according to their percentage, if over
one percent that are present in the
product and are followed by the list of
the coloring agents used in the product
➢ An explanation of what the product’s
function is
➢ Directions for storing the product, when
applicable
➢ Instructions for using the product, when
applicable
➢ Precaution or warning statements, when
applicable
➢ Weight at time of packaging
● How the information should appear on the
packaging
● Requirements for primary packaging and
secondary packaging if applicable
● Manufacture date or batch number that can
be used to identify the product
Legal Relevance of ISO 22715
While ISO 22715 is not legally binding, it is however,
the common denominator of most of the national
regulations that apply to the packaging and labeling of
cosmetic products. Country regulators refer to ISO
standards as guidelines to best practices for the various
sectors for which they apply. Often, in order to comply
with a local regulation, an individual, business or
manufacturer must comply with the applicable ISO
standard(s).
As ISO maintains the copyrights for its standards, the
organization is able to better distribute their standards
and update as needed. The organization updates their
standards every five to seven years in order to keep up
with new technologies.
For the cosmetic sector there are 26 published
standards, including ISO 22715 that are overseen by
ISO’s cosmetic product technical committee, which was
created in 1998. The committee includes
standardization bodies from major markets, including
leading ASEAN countries, the United States as
represented by ANSI and most European countries.
Currently there are 39 countries that participate in the
standardization of cosmetic products and 27 observing
countries with the committee.
The Deviation between Local Regulations and the ISO
There are two main reasons why local regulations and
the ISO deviate:
1. The national standardization institutes need to
find a common denominator. This is not
necessarily a bad thing being that this creates
a common ground in which to start. Local
legislation may exceed the requirements that
are specified within the ISO standard. It is
very rare that local legislation will contradict
the ISO standard.
2. The national standardization bodies
represented in the ISO committee and the
regulatory bodies in the corresponding
countries are not the same. For example, in
the United States, the Food & Drug
Administration (FDA) regulates cosmetic
packaging. However, the standards that are
used come from the American National
Standardization Institute (ANSI). The FDA is a
dues-paying member of ANSI. The level of
cooperation between organizations plays a
major part is the coherence of standards and
regulations.
When developing standards, it is suggested to
base the conception on the coinciding ISO. Local
regulations may exceed the requirements but it is
the best starting point for international compliance
with regulations.
What you should know when packaging cosmetics
compliant to EU regulations

In Europe cosmetics manufacturers and marketers must comply with

the Regulation (EC) No. 1223/2009 of the European Parliament and of
the Council on cosmetic products (November 30, 2009). This regulatory
framework strengthens safety standards and simplifies procedures for
cosmetic products sold in the EU.
Regulation Background
The EU cosmetic directive adopted in 1976 known as
"Directive 76/768/EC" was superseded by the 2009
regulation.
In contrast to a directive, a regulation is automatically
legally binding in all EU member states and does not
need to pass the local parliaments. This is in fact
advantageous for cosmetics manufacturers, as a
European regulation allows for a coherent approach in all
Europe, instead of searching compliance with all EU
member state regulations individually.
The new rules maintain original product safety standards
while incorporating new technological developments.
While keeping the ban on animals test in place, the
revision now also addresses the use of nanomaterials.
Key Points in the Regulation
● manufacturers must meet specific requirements
when preparing a product safety report before it
can be put on the market
● defines a "responsible person" as a legal and
natural person and their obligations in regards to
who can market cosmetic products
● manufacturers must give notification of their
cosmetic products via the EU Cosmetic Products
Notification Portal (CPNP)
● a responsible person is required to disclose
serious undesirable effects (SUE) to EU
members and national authorities, who compile
feedback from users, health professionals and
others
● colorants, preservatives and UV-filters (including
those comprising nanomaterials) must be
approved
● when products include nanomaterials the
ingredients must be labeled with the word "nano"
in brackets after the name of the substance,
such as "titanium dioxide (nano)"
Product Safety
All cosmetic products marketed to the public must be
safe for human health under normal use with the
following factors taken into consideration:
● presentation that conforms with Directive
87/357/EEC (avoiding resemblence with
food to enhance child safety)
● labelling
● instructions for use and disposal
● any other indication or information provided
by the responsible person, as defined in
Article 4
For cosmetic products sold outside the Community
without being exported then imported, the manufacturer
must designate in writing a responsible person within the
Community. For imported cosmetic products, importers
act as the responsible person, unless they designate in
writing a responsible person within the Community. The
same is true of distributors that place cosmetic products
or modifications on the market under their name or
trademark.
Labelling
Labels on cosmetic products must be easy to read,
although information can be abbreviated. In the
case of multiple addresses, the one where the
responsible person is most readily available must be
highlighted.
According to Article 19 in the Regulation the label
must include:
● name, registered name and address from
responsible person
● country of origin
● nominal content at the time of packaging
measured by weight or volume with some
exceptions
● expiration data for storing under
appropriate conditions
● must say "best used before the end of" or the
symbol shown in Annex VII point 3, followed by
the date or details
● date of minimum durability must be clearly
visible and consist of either the month and year
or the day, month and year
● when appropriate, an indication of conditions
that must be satisfied to ensure stated
durability
When minimum durability is over 30 months, it is not
necessary to indicate a date of minimum durability.
Such products, however, must list how long a product
is safe after opening.
Point 2 of Annex VII followed by the time period in
months or years explains how this information must
be indicated, which must include:
● manufacturer batch number or reference that
identifies the product
● precautions taken for observation or product
use, with respect to Annexes III or VI
● the term "ingredients" on the packaging
followed by a list
Definition and Listing of Ingredients
An ingredient, as determined by this regulation,
means any substance or mixture in the
manufacturing process that is an intentional part of
the product. Items that do not fit the definition of
ingredients include impurities in the raw materials
used and subsidiary technical materials used in the
mixture that do not end up in the final product.
Perfumes and their raw materials must be referred
to as "parfum," while aromatic compositions and
raw materials must be called "aroma." Any other
substances defined as "Other" in Annex III must be
listed.
The list of ingredients must appear in descending
order of weight when the items were
added to the product. However, ingredients that
account for less than 1% of the product may be
listed in any order following those about 1%.
Colorants, except those in hair dyes, may be
listed in any order following the cosmetic
ingredients. In the case of colour shades,
colorants not mean for hair may be listed, using
language such as "may contain" or the symbol
"+/-." The CI (Colour Index) nomenclature must
be used when appropriate.
Other Required Listings
● function of the cosmetic product, unless it
is obvious, listed on an attachment
● small products with containers too small
to have readable text must be displayed
on a notice in immediate proximity where
the product is sold
● listings for products that aren't
pre-packaged, packaged at the point of
sale or prepackaged for immediate use
will be determined by Member States
Product Claims
Labelling must be clear so that consumers are not
misled by any of its characteristics, which include
text, names, trademarks, pictures and figurative or
other signs.
EC Regulation 1223/2009 on cosmetics
The objective of Regulation (EC) No 1223/2009 of the European
Parliament and of the Council of 30 November 2009 is to establish
standards for cosmetic products that are available on the market.
Compliance to these standards help ensure the functioning of the
internal market, but more importantly, a high-level of protection for the
health and safety of citizens of the European Union.

Regulation (EC) No 1223/2009 supersedes previous Directives that

applied to cosmetic manufacturers. All member states are required to
abide by the guidelines set by the Regulation as of its effective date.
Safety and Responsibility
Article 3 of EC No 1223/2009 states that before
releasing a cosmetic product on the market, the
cosmetic product must be safe for human health
during its intended use or what would be
considered reasonably foreseeable conditions of its
use. Factors that would support the safety of the
product would include its presentation in regards to
Directive 87/357/EEC, its labelling, and its
instructions for use and disposal. Furthermore,
information that is supplied through the named
manufacturer’s representative, referred to as the
“responsible person” under Article 4 of the
Regulation is also taken into consideration.
The responsible person is charged with the
obligation of ensuring that the cosmetic product is
in compliance with the standards laid out in EC No
1223/2009. If for any reason a cosmetic product is
found to present a threat to human health, the
responsible person must immediately notify
competent national authorities within each of the
Member States where the product has been made
available. Included in this notification would be the
details of the risks of using the product, issues of
non-compliance to the Regulation, and what
corrective measures will be taken.
Before placing a cosmetic product on the market,
the responsible person must demonstrate
compliance with Article 3. This is accomplished
through the performance of a safety assessment
that is based on the product’s relevant information
and providing a cosmetic product safety report that
is in accordance with Annex I of the EC No
1223/2009.
Maintaining a Product Information File
Article 11 of the Regulation stipulates that the
responsible person must keep a product
information file for each cosmetic product that is
placed on the market. This file must be kept on file
for at least 10 years after the last batch of the
cosmetic product was put on the market. The
product information file shall consider of information
and data regarding the:
● Description of the cosmetic product
● Safety report for the cosmetic product
● Proof of the effect that the cosmetic product
claims to do
● Data on animal testing that has been
performed by the manufacturer or any agents
or suppliers
Access to the product information file must be
made readily accessible by the responsible person
in electronic or other formats via the address
provided on the product’s label to the authority of
the Member State where the file is stored.
Sampling and Analysis of Cosmetic Products
Article 12 of Regulation 1223/2009 stipulates that
cosmetics be sampled and analyzed in manner that
is reliable and reproducible. When local Community
legislation regarding sampling and analysis is
non-existent, it will be presumed that the
manufacturer will use methods of harmonized
standards that have been published in the Official
Journal of the European Union.
Notification of the EU Commission
Before a cosmetic product can be placed on the
market, the responsible person must follow the
guidelines given under Article 13 of Regulation
1223/2009 for supplying information to the
Commission including:
● Identifiable name and category of the product
● Name and address of the responsible person who
can provide the product’s information file
● Country of origin if the cosmetic product is
imported
● Member State(s) where the product will be placed
on the market
● Contact information for a physical person in the
event contact is necessary
● Ingredient information, including presence on
nanomaterials and information pertaining to
Chemicals Abstracts Service (CAS) for
ingredients classified as carcinogenic or toxic.
Restrictions for Certain Substances
Chapter IV of Regulation 1223/2009 states that
cosmetic products shall not contain:
● Prohibited substances that are listed in Annex II
● Restricted substances listed in Annex III
● Any colorants than those listed in Annex IV
● Preservatives other than those listed in Annex V
● UV-filters other than listed in Annex VI
Chapter V refers to the prohibition of animal testing
of the final formulation of cosmetics to be placed on
the market using methods other than alternative
methods that have been validated and adopted by
the EU community.
Requirement for Labelling Cosmetic Products
Cosmetic products may only be made available on
the market if their container and packaging meet
the guidelines for providing information to the
consumer. The law of the Member States where the
cosmetic product is made available to consumers
will determine the language that the required
labeling information will need to be provided in.
The following information must be presented in a
legible format, with visible lettering and of an
indelible nature:
● Name and address of the responsible person
and country of origin for imported products
● Weight or volume of cosmetics at time of
packaging
● Expiration date of product when stored under
appropriate conditions
● Precautions to be followed in the use of the
cosmetic product
● Identifying batch number for the manufacture of
the product
● Explanation of the function of the cosmetic
product if its use is unclear
● Ingredients listed in descending order of the
weight of each when added to the product;
When it is impractical or impossible to print this
required information on the container or packaging
of the cosmetic product, the information may be
supplied via attached leaflet, tag, card or label. In
instances, such as with soaps, bath balls or other
small cosmetics, this information is required to
appear on a notice on or in immediate proximity to
the container where said cosmetics are presented
for sale.
Consequences of Non-Compliance
The named responsible person is charged with the
responsibility of taking all appropriate measures to
ensure that the cosmetic product complies with the
standards provided under Regulation 1223/2009.
When a product has been found to be in
non-compliance, the competent authorities will
require the responsible person to take corrective
actions to bring the cosmetic product to conformity,
withdraw the product from the market, or recall the
product within a prescribed time limit that will
commensurate with level of risk to the health and
safety of the public. The responsible person is
required to report the measures that he or she has
taken in efforts to remedy non-compliance issues.
In circumstances where non-compliance is not
remedied, the competent authority shall inform the
competent authority of the Member State from
which the responsible person is established. If the
competent authority has reasonable grounds for
concern or ascertains that a cosmetic product is a
serious risk to human health, they shall move
forward instituting appropriate provisional measures
to withdraw, recall or restrict the availability of the
product.
What you should know when packaging cosmetics
compliant to FDA regulations

The cosmetics industry, unlike the food or pharmaceutical industries,

does not have to deal with stringent regulations by comparison.
Cosmetic companies, however, still must follow rules under the Federal
Food, Drug and Cosmetic Act and other consumer laws, but are not
required to register or license products. In other words, they still must
market safe products. Here are deeper details on regulations that
shape cosmetic packaging.
FDA Attitude on Cosmetic Ingredients
FDA approval is not necessary to put a cosmetic
product on the market. But manufacturers and
marketers still have a responsibility to make sure
they are unleashing safe products on the public.
Disregard for safety can lead to major penalties.
Even though the FDA does not require specific
safety testing, it still oversees the cosmetics
industry and sometimes makes recommendations
for recalls, if products are found to be dangerous.
The government, for the most part, does not have
specific requirements regarding ingredients of
cosmetic products, other than respect to chemicals
that affect colors. Other than most hair dyes, color
additives must meet certain FDA requirements. The
FDA may still inspect manufacturing facilities to
make sure that proper controls and practices are in
compliance with applicable laws.
The FDA might periodically purchase cosmetic
products to analyze them for potential hazards or
other issues. If problems arise associated with
ingredients, the agency may issue consumer alerts
through mass media press releases. The agency,
however, does not have the available resources to
monitor every cosmetic product on the market.
Independent researchers, however, such as the
Cosmetic Ingredient Review (CIR) panel, may notify
the FDA on safety issues that affect consumer
safety. Health care providers also play a role in
working with the FDA to keep commercial cosmetic
products safe.
FDA Action
For the most part, the FDA allows cosmetic
manufacturers and marketers to voluntarily
monitor safety of their products through its
Voluntary Cosmetic Registration Program. In
addition to requesting a product recall, here are
key activities in which the FDA does get involved
when a product fails to meet minimum standards:
● request for injunction through a federal court
● request for seizure of products by U.S.
marshals
● initiation of criminal litigation
● deny cosmetic imports
Preserving Product Quality
Cosmetic packaging must be designed to preserve
the product quality. The FDA requires that
packaging will protect the product against the
following potential types of damage once it leaves
the factory:
● mechanical
● thermal
● biological
● chemical
● by radiation (e.g.,
UV light)
● malicious human
tampering
● electric
● compression
Environmental conditions must be taken into
account each step of the distribution and
marketing process from transport to storage to
display. The product must be resistant to
temperature, radiation and bacteria, as well as
withstand damage from inadequate storage.
Label Transparency
It is of monumental importance that labels contain
accurate information. So the key concept to
remember is that information on labels must not
be deceptive. The FDA does allow various
chemicals to be summarized under the umbrella
term "fragrance." The agency may conclude that a
product is misbranded if the following violations
occur:
● false or misleading labeling Conclusion
● label omits name and address of the
manufacturer, packer or distributor While the FDA does not order recalls for
● net quantity of contents is not listed cosmetic products, it still conducts research
● the labeling fails to be conspicuous for and may request a marketer to pull a product.
consumers to read
The FDA may impose penalties due to lack of
● misleading container or fill
compliance with basic laws under the FD&C
Act, but its oversight is minimal compared with
The intended use of the product must also be how it monitors food and drug items.
specifically stated, along with the Packaging is key to cosmetic products
consequences that result from unintended meeting basic requirements of the law and
usage. The legal definition of the term should not be taken for granted.
"intended" specifically corresponds with
package labeling. Courts usually depend on
consumer perceptions of label meanings and
not so much on the company's interpretation.
In other words, the intended use must be
stated clearly.

The legal definition of a cosmetic crosses over

into the drug category when the intended use
is associated with cleansing, beautification,
promotion of attractiveness, disease
prevention or other issues that affect the
structure or function of the human body. A
cosmetic also is classified as a drug when
intended use is associated with exerting
physical or psychological effects.

The term "package" is defined as the outer

container of a product, such as a box, jar,
bottle or carton. It is also defined as the
container of the product substance even if it is
not displayed in the outer packaging. The
term "label" carries the definition of "written,
printed or graphic matter affixed to any
consumer commodity or affixed to or
appearing upon a package" for any consumer
item. These definitions appear in the FD&C
Act.
Important legal requirements to Cosmetics in the
US-Market
The Federal Food, Drug and Cosmetic Act (FD&C Act, FFDCA or
FDCA) of 1938 established the parameters for cosmetics marketing in
the United States. The following explains how the FDA regulates
cosmetic products.

This law in section 201(i) defines cosmetics as "articles intended to be

rubbed, poured, sprinkled or sprayed on, introduced into or otherwise
applied to the human body ... for cleansing, beautifying, promoting
attractiveness or altering the appearance."
Cosmetic Examples
No registration is required to market cosmetics.
● skin moisturizer However, the FDA at times may inspect the
● perfume facilities of cosmetic manufacturers. In the event a
● lipstick cosmetic product is found to be dangerous to the
● fingernail polish public, it is up to the manufacturer or distributor to
● eye and facial makeup take voluntary action to resolve the issue. While
● cleansing shampoo the FDA does not have the authority to recall a
● deodorant cosmetic product, the agency still monitors the
industry and sometimes requests companies to
recall their own products. The FDA does monitor
imports.
Hair colors and permanent waves also fit the legal
definition of cosmetics, along with other
Reasons for voluntary recall include:
substances. Soap, however, is not considered a
cosmetic product. When marketing involves
● deceptive marketing
interstate commerce, cosmetic products may not
● defective products
contain poisonous, contaminated or decomposed
● safety hazards
substances and must be branded properly.

Here are examples of misbranding:

● labels with false or misleading information
● not all ingredients or required information are
listed on the label
● required information is not conspicuous
● misleading containers
● failure to list material facts involving safe use
and warnings
● color additives besides hair dye do not meet
applicable regulations if FD&C Act section
721
● packaging or labeling violates the Poison
Prevention Packaging Act of 1970, section
602
Safety of Cosmetics
Conclusion
The FDA states: "The safety of a product can be
adequately substantiated through (a) reliance on
already available toxicological test data on
individual ingredients and on product formulations
that are similar in composition to the particular
cosmetic and (b) performance of any additional
toxicological and other tests are appropriate in
light of such existing data and information."
Compared with the food and drug industries,
cosmetic manufacturers and distributors face
limited government oversight. Companies must
still take responsibility for ensuring that their
products are safe.

Manufacturers and marketers of cosmetics are

legally responsible for meeting government
regulations of products, even though safety tests
are not required. Furthermore, companies are not
required to share any safety information with the
FDA. In other words, it's up to cosmetics companies
to conduct their own testing to make sure toxic
products are kept off the market. Companies don't
even have to disclose safety information to the
FDA.
Metal packaging of food or cosmetics in the USA -
what is generally recognized as safe?

The United States Congress passed a set of laws known as the Federal
Food, Drug and Cosmetic Act (FD&C) in 1938. FD&C gave the Food
and Drug Administration (FDA) the authority to oversee the safety of
food, drugs and cosmetic products. The impetus behind passing the
FD&C Act was to prevent tragedies, such as the instance of more than
100 patients dying as a result of using diethylene glycol to dissolve a
sulfanilamide medication to be used in a liquid form from reoccurring.

Over the years, the FD&C Act has been updated numerous times to
reflect new findings about the safety of various ingredients and
effectiveness of previously marketed pharmaceuticals. Updates to the
FD&C also ensure that manufacturers must properly use packaging that
is suitable for food contact and use packaging techniques to keep the
public safe. Included in the FD&C are guidelines for FCS and GRAS
substances that come into contact with food. These guidelines are
followed when creating coatings that are used inside metal packaging,
including those made of tin or aluminum.
What is a Food Contact Substance (FCS)?
While the ingredients that are used in the process
of creating a food that will require packaging,
exposure to certain materials may make it
dangerous to eat. Thus, there is a need for
oversight on what substances can come into
contact with food to protect the public.
Under the FD&C Act, Section 409 defines a Food
Contact Substance (FCS) “as any substance that is
intended for use as a component of materials used
in manufacturing, packing, packaging, transporting,
or holding food if such use of the substance is not
intended to have any technical effect in such food.”
According to the FD&C, there is a hierarchy that
applies to FCS:
● A Food Contact Substance is a singular
substance, for example a polymer or a
polymer that contains an antioxidant. This
substance is considered as a pure substance
under the Chemist’s definition of what a
substance is. While several monomers might
be used to compose a polymer, the
composition is still well-defined.
● Food Contact Material (FCM) is produced with
the FCS and often, additional substances. It
can be a mixture that varies in composition,
for example, a polymer that contains an
antioxidant.
● From the Food Contact Material (FCA), the
finished item that will come into contact with
the food item is fabricated. That finished item
is referred to as a Food Contact Article and
could be a dough hook, finished film, tray,
bottle or other type of item that has been
made from the FCM.
What Does the Term GRAS Refer To?
The term GRAS is an acronym for “Generally
Recognized As Safe.” Sections 201(s) and 409 of
the FD&C Act defines a GRAS as:
Any substance that is intentionally added to food
is a food additive, that is subject to premarket
review and approval by FDA, unless the
substance is generally recognized, among
qualified experts, as having been adequately
shown to be safe under the conditions of its
intended use, or unless the use of the substance
is otherwise excluded from the definition of a food
additive.
These substances are differentiated from food
additives by way of the information given to
support the determination of being GRAS. This
information would be generally accepted by the
scientific community and would need to be made
available to the public. Additionally, the
information should be of the same caliber of
information that would normally be given to
support the safety of a food additive.
Metal Packaging Safety
Over two centuries ago, tinplate was introduced as
material for making food containers. However,
food poisoning from ingesting excessive amounts
of metals became a common occurrence from
foods that were packaged in those containers.
Because of this issue, a group of physicians in
Germany recommended that the use of tinplate
should not be used in making containers for food.
Today, with improved technology, the quality of
tinplate that is used in the making of containers
has improved dramatically. Additionally, foods,
such as those that are acidic in nature that would
normally eat away at tin are packaged in
enameled coated tinplate containers. Unlike other
elements, such as copper or iron, tin has not been
found to be an essential element that is needed
the human diet. However, the medical community
has concluded that there are no long-term health
effects related to the ingestion of trace amounts of
tin that might be found in beverages or solid foods
packaged in tin containers.
Aluminum is also a nonessential metal in the
human diet and has a history of being suitable
for food contact. The U.S. FDA has determined
aluminum to be GRAS and it can often be
found in food ingredients that are used to
preserve, color or leaven various foodstuffs.
However, aluminum is not used in its pure form
as a packaging material, because of the risk of
corrosion from certain foods. Instead, to
strengthen and reduce corrosion resistance,
copper, zinc, iron, chromium or manganese are
added to aluminum. Similar to tinplated
containers, food-grade aluminum containers
are also coated with an enamel on their inner
surface to prevent acidic foods or beverages
from corroding the metal.

When manufacturing tin and aluminum plates

suitable for food contact, Desjardin uses a
transparent “food varnish” to prevent any
reactions with food ingredients. This varnish
has been explicitly approved by the FDA and
the EU. In addition, every ingredient needs to
be tested before serial production on any
possible and unwanted reactivity (e.g., through
acidity of the inserted substance).
Fair Cosmetic Packaging and Labelling
Product information is required on packaging for identification purposes
to help both professionals and consumers understand product contents
and who to contact for more information. The Fair Packaging and
Labelling Act took effect in 1967 after it was passed by Congress the
previous year. This federal law supersedes all state laws. Here are
details on how this law applies to fair cosmetic packaging.
Basic Labeling Requirements
1. product identity
2. contact information for the manufacturer and
packer/distributor
3. net quantity of package contents in both metric
and US customary units
Purpose of Fair Cosmetic Packaging Regulations
Congress wanted to make sure consumers have the
opportunity to research accurate information about
packaged commodities in various industries before
making purchasing decisions. Usually this type of
legislation is a result of too many complaints about
marketers taking advantage of consumer ignorance
through false or misleading advertising. Despite the
regulation, however, some vendors still try to get away
with exploiting society's lack of scientific knowledge
regarding raw materials and measurements. Sometimes
the problem gets deeper with products made of
dangerous substances disguised as more generic or
vague ingredients.
By passing this consumer protection law, federal
authorities hold cosmetic manufacturers and distributors
to higher standards than the early days of the industrial
revolution. Although regulations are fairly straightforward
and relatively not as comprehensive as other laws,
cosmetic makers must be in compliance in order to avoid
penalties and play a high profile role in the industry.
Failing to meet these basic requirements could result in
fines or recalls.
Chapter 39 of the Fair Packaging and Labelling Program
specifically prohibits distributors to engage in unfair and
deceptive packaging. Exemptions, however, are made
for wholesalers or retail distributors, who are not bound
to participate in the packaging or labelling requirements
of commodities, as defined by the Federal Food, Drug
and Cosmetic Act.
Product Identity
The commodity must include a label that identifies the
product, which is typically its usual brand name. In
other words, the name should not confuse the
consumer with a similar product or a more popular
competitor.
Small companies that try to exploit the names of more
well known brands with misleading names are in
violation of this regulation.
Contact Information
The label must contain the name and place of
business of the manufacturer, packer or
distributor. Typically this means the physical
address of these entities. While the law does not
specify that a phone number must be given, many
companies provide a contact number to show that
they have an open door policy to communicate
with customers, trade professionals and
authorities.
Package Contents
Although the manufacturer is not required to
divulge trade secrets on the packaging, the firm
must list ingredients in the order of decreasing
predominance on the label if the product contains
two or more ingredients. The packager must
prevent containers from housing misleading
"nonfunctional slack-fill" (the difference between
container capacity and the product). In order
words, the company cannot try to cheat the
consumer with too much empty space in a
package.
Fair cosmetic packaging means that the package
content must match the information that is listed
on the label in terms of ingredients and net
quantity. Consumers must be able to make fair
value comparisons with other competing retail
products.
Net Quantity
The net quantity of product contents, as measured
by amounts that describe weight or mass, must be
included on the label as well. Alternatively, the
number of units within the package may be listed
instead. Measurement based on size must include
both inches/pounds, depending on appropriate
terminology, as well as metric units. In other
words, for some cosmetic products, quantity will
be measured in weight, while others will be
measured in area or number of units.
In the case of liquids, the measurement can be Conclusion
listed as whatever best represents the most
appropriate largest whole unit, such as quarts or The cosmetic industry is one of the least regulated
pints. Decimal fractions may be used for precision. industries in America, but it must still comply with
For products that occupy area, appropriate the Fair Cosmetic Packaging and Labelling Act, as
measurement units may be in square inches or well as the Federal, Food, Drug and Cosmetic Act
square feet. and other consumer laws. Entities that oversee
these regulations include the FDA and the FTC.
Government Enforcement of Regulations The requirements mainly involve publishing
accurate company and product information on
As per section 1456, enforcement of fair cosmetic labels.
packaging regulations includes government
oversight of (a) misbranded consumer
commodities, (b) unfair or deceptive acts or
practices in commerce and (c) imports.
Misbranded consumer commodities are defined by
the Federal Food, Drug and Cosmetic Act.
Examples of misbranding on the label include:

● false or misleading information

● omission of the name and address of the
manufacturer, packer or distributor
● unlisted net quantity of contents
● information that is inconspicuous or difficult
to read
● misleading nonfunctional slack-fill

The label must clearly state the intended use of

the product and the potential risks from misuse of
the product. Courts typically rely on consumer
interpretations of label meanings instead of the
company's intended definition. Cosmetic entities
essentially must avoid disguising ingredients that
are designed to cut corners on quality, quantity or
cost in such a way that deceives the consumer. All
imports into the United States must comply with
regulations of the Federal Food, Drug and
Cosmetic Act.
References and Further Reading
• More posts on Cosmetic Packaging, by Alex Cosper and Dawn M.
Turner

• Is It a Cosmetic, a Drug, or Both? (2016), by the U.S. Food and Drug

Administration

• Regulation (EC) No ´1223/2009 on Cosmetic Products (2009), The

European Parliament the the European Council

• ISO 22715:2006: Cosmetics -- Packaging and labelling (2006),

International Organization for Standardization

• 4 Tips for Researching and Finding Wholesale Suppliers (2012), US

Small Business Association

• 13 Tips for Negotiating with Suppliers (2012), Inc

• Supplier Selection (2009), Damian Bell

• Fair Packaging and Labelling Act (1967), by Federal Trade Commission,

USA

Images Source

● "FDA Cleared", Courtesy of John Fischer, Flickr, (CC BY 2.0)

● "Laboratory of Noses", Courtesy of M. Hagemann, Flickr, (CC BY-SA
2.0)