The document provides an overview of sunscreen regulations around the world. It discusses regulations in several major markets including the European Union, United States, Canada, Japan, China, South Korea, ASEAN countries, and others. Regulations vary between classifying sunscreens as cosmetics or drugs and differ in allowed active ingredients, testing methods, and labelling requirements like SPF values and UVA protection claims. Harmonization efforts aim to standardize regulations internationally but many differences remain between regions.
Jatin an overview of sunscreen regulations in the world
1. An Overview Of Sunscreen Regulations In The World
SUBMITTED BY – JATIN SINGLA
M.PHARM(PH’CEUTICS)
ISFCOLLEGE OF PHARMACY,MOGA
2. An Overview Of Sunscreen Regulations In The World
Abstract:
Among cosmetics, the category of
sunscreens is certainly a fascinating one
for a cosmetologist (the sort of expert that
supposedly has knowledge of chemistry,
toxicology, dermatology, rheology, and
even marketing, etc.). The development of
sunscreens brings along many technical
and toxicological issues, which stem from
the requirement of having contrasting
ingredients for opposite needs in the same
formula. Good spreadability is in contrast
with water resistance, and the proper level
of filters is in contrast with the quality of
the texture and solvents needed for product
.stability. Once a potential solution is
found for these issues, the development
process of a new product is usually further
complicated by marketing and regulatory
issues. Many useful and practical - and in
fact safe - ingredients cannot be used due
to a bad reputation they have in web-based
blogs and forums or simply because there
has been scare mongering, which leads the
developer to avoid parabens, alumina and
nano ingredients (1). The other side of the
coin is the burden of regulations that
classify sunscreens in very different ways
in different areas of the world.
Keywords:
Sun produces light and warmth but also
Ultraviolet (UV) radiation. UV radiation
cannot be seen or felt.
o It is UV radiation, not the warmth
or brightness of the sun that causes
changes to skin color, damage to
eyes, and other bad health effects.
BENEFIT
• Light
• Photosynthesis
• Outdoor environment for physical
activity
• Production of vitamin D
• Happy & positive feelings; good
mood
• Keeps up warm
• Hepls plants grow
• Makes vitamin D
• Kills germs
3. HARMS
• Suntan
• Sunburn
• Premature aging
• Liver spots
• Loss of elasticity
• Suppression of immune system
• Skin cancer
• Wrinkles
• Eye damage
Introduction:
From the regulatory perspective (2), we
can identify some major geographic areas
to consider, though the European approach
(and this is reasonable due to the
dimension of that market) is paving the
way for many other areas, which have
eventually adopted the same concept and
set of rules. We can broadly identify:
• European Union EEA (Switzerland,
Norway, Iceland)
• USA
• Canada
• Japan
• South Korea
• Brazil
• China
• Taiwan
• ASEAN countries
• MERCOSUR Countries
• RUSSIA
• Australia
• New Zealand
• Middle East/Arabic countries (Turkey,
Emirates, Morocco, Egypt)
• India
• African countries (South Africa, Nigeria,
Tanzania)
• Ecuador
• Others It’s not easy to compare the
different regulations available, largely
because cosmetics are defined in different
ways. Moreover, in the case of sunscreens,
these are classified as “over the Counter”
(OTC) products in the USA (this means
they are regarded as drugs and not as
cosmetics) or according to specific
provisions like in Australia. The
4. classification is not the only critical point
or main hurdle in the development of an
internationally-recognised formula, since
each authority has developed specific lists
of allowed UV filters and their own
systems to calculate, test and label the SPF
factor. It is quite an extensive task to go
into detail for each of the aforesaid world
areas. Therefore, we will provide an
overview of the main markets which
should be interesting for those companies
that are looking to take their products to
the global market. EUROPEAN UNION,
SWITZERLAND, NORWAY AND
ICELAND We can start with the European
Union. The current EU Regulation (3)
EC/1223/09 replaced the previous system
based on Directive 76/768 providing all
member states with the same legal
framework, based on the negative and
positive lists of ingredients. The same
framework is also applied in New Zealand,
some of the Middle East/Arabic countries,
Turkey and ASEAN countries. In these
areas the EU regulation is accepted and
applied as it is or with minor changes. The
main point in this case is to check whether
the local legislative status of some of the
ingredients is updated. According to the
definition given by the Regulation, a
“cosmetic product” means any substance
or mixture which is intended to be placed
in contact with the external parts of the
human body (epidermis, hair system, nails,
lips and external genital organs) or with
the teeth and the mucous membranes of
the oral cavity with the sole purpose of
cleaning them, perfuming them, changing
their appearance, protecting them, keeping
them in good condition or correcting body
odours. Among these functions, the
protection of skin from damage due to sun
exposure is referred to as a cosmetic
action. Therefore, in Europe, sunscreens
are considered as cosmetics. In Europe, the
system is constantly updated as technical
progress evolves, on the basis of the
Scientific Committee on Consumer
Safety’s (SCCS) recommendations on
safety of ingredients. The Committee
provides recommendations on health and
safety risks (chemical, biological,
mechanical and other kinds of physical
risks) of non-food consumer products (e.g.
cosmetic products and their ingredients,
toys, textiles, clothing, personal care and
household products, etc.) and services (e.g.
tattooing, artificial sun tanning, etc.).
These recommendations usually lead to an
update of regulations, whose annexes have
to be considered for formulating a
sunscreen. These are: I Cosmetic product
safety report II List of substances banned
in cosmetic products III List of substances
which cosmetic products must not contain
according to restrictions IV List of
colourants allowed in cosmetic products V
List of preservatives allowed in cosmetic
5. products VI List of UV filters allowed in
cosmetic products The current list has 28
filters listed along with specific limits of
concentration and with some specific
warnings for the labelling of the products.
The testing and labelling is also included
in the Commission Recommendation of
September the 22nd, 2006 on the efficacy
of sunscreens and the claims made relating
thereto. This recommendation sets some
specific guidelines regarding the
UVA/UVB ratio of protection, specific
labelling warnings and the labelled
category of protection starting from low
protection (SPF 6) to very high protection
(SPF 50+).
• Minimum efficacy - lowest allowed
claim SPF 6
• UVA protection must be at least 1/3 of
UVB protection (UVA/UVB ratio)
• Critical wavelength for testing is at least
370 nm
• Precautions and usage instructions –
recommendations for protection must be
shown in labeling
• 4 protection categories (4) (see extract
from recommendation)
• Testing made according to SPF + UVA
method (in vitro systems preferred for
ethical reasons) USA The sunscreens are
classified in the USA as “over the counter”
(OTC) drugs and the main reference
documents are the Final Rule (5) published
in 2011 and the Sunscreens Innovation Act
published in 2014. The classification as
OTC means that all the limits due to the
approval process and strict definition of
labelling have their effect in this category
of products. The Sunscreen Innovation Act
has been approved with the declared
purpose to make some of the new filters
already in use in the EU and in other
countries available to the US market. The
Act has also been developed according to
the “material time and material extent
concept”, meaning that active ingredients
that have been marketed “to a material
extent” and “for a material time” in a
foreign market and are obviously
supported by safety data can be added to
an OTC (therefore to sunscreens) drug
monograph. The decision made in 1970 by
the FDA to place sunscreens products in
the OTC category is actually blocking
some of the new sunscreens available in
Europe. It has been a long time since the
FDA has approved a new sunscreen due to
the lack of safety data, as well as
insufficient funds. The Sunscreen
Innovation Act didn’t change the situation
too much and the prospect of seeing
miloxate, bemotrizinol, bisoctrizole,
drometrizole trisiloxane, ecamsule,
enzacamene, iscotrizinol, and octyl
triazone approved in the US market is still
6. far away. The complex work of developing
sunscreens is certainly not easy due to the
fact that some of the allowed filters are not
particularly useful for the textures being
developed today due to their technical
characteristics. Many of the aspects the
Final Rule deals with are mostly labelling
matters. Label wording is strictly
regulated, such as where and how to write
relevant information like water resistance
or, in the case of sunscreens with a broad
spectrum (SPF >15), which products can
bear the claim: ‘‘if used as directed with
other sun protection measures, (the
product) decreases the risk of skin cancer
and early skin ageing caused by the sun’’.
One part of the regulatory system for
sunscreens is represented by the
monograph, which essentially provides a
standard for active ingredients. If a
monograph has been issued for a product,
all a company has to do to be allowed to
market it is to demonstrate that it has met
the standards of that monograph. This
method allows new formulas to be
introduced to the market and is different
from the aforesaid regulations on new
ingredients. Twenty-four Ingredients are
currently regulated by the FDA through its
various final monographs. Sunscreen
Ingredients Regulated by OTC Monograph
(21 CFR 352.10) (6):
• Aminobenzoic acid (PABA) up to 15%
• Avobenzone up to 3%
• Cinoxate up to 3%
• Dioxybenzone up to 3%
• Homosalate up to 15%
• Menthyl anthranilate up to 5%
• Octocrylene up to 10%
• Octyl methoxycinnamate up to 7.5%
• Octyl salicylate up to 5%
• Oxybenzone up to 6%
• Padimate O up to 8%
• Phenylbenzimidazole sulfonic acid up to
4% • Sulisobenzone up to 10%
• Titanium dioxide up to 25%
• Trolamine salicylate up to 12%
• Zinc oxide up to 25%
• Ensulizole up to 4%
• Homosalate up to 15%
• Meradimate up to 5%
• Octinoxate up to 7.5%
• Octisalate up to 5%
• Octocrylene up to 10%
• Oxybenzone up to 6%
• Padimate O up to 8%
7. A new monograph is underway, but we’ll
have to wait until 2019-2020 to anticipate
solving some of the open questions
relating to sprays and other forms
(powders, wipes), ingredients, high SPF
values, etc. In some cases, single states,
e.g. California, have specific state rules
that make it more complex, such as the
PROPOSITION 65 of the State of
California of January the 1st, 2015,
requiring to print the following warning on
labels of products containing the cancer-
causing chemical benzophenone:
“WARNING: This product contains
benzophenone, a chemical known to the
State of California to cause cancer.”
CANADA Health Canada has issued a
regulatory framework for cosmetics which
is a blend of the EU and US regulations.
Cosmetics are regulated under a
framework that resembles the European
one (e.g. with a hotlist of ingredients),
while sunscreens are classified in different
ways according to the single ingredient
and may fall either under the Natural
Health Product or the Drug Products
regulations. A monograph (last revision
issued on 23/06/2015) entitled “Sunscreen
monograph” collects all the points referred
to this class of products. For the marketing
of a product a Product Licence Application
must be filed. Canada’s monograph
includes sprays and powders. It refers to
all products including those referred to as
secondary sunscreens. In fact, specific
provisions are given for labelling broad
spectrum and UVA protection, whereas
certain claims are not allowed, unless
supported by existing scientific data.
ASEAN As previously stated, the
cosmetic directive for ASEAN (7)
countries is quite the same as the EU
regulatory framework. Differences may
arise due to a delay in adopting the EU
approach and decisions and because of a
specific warning that is mandatory, i.e.
“Do not stay too long in the sun, even
while using a sunscreen” that must be put
onto products sold as primary sunscreens.
The ASEAN scientific committee act like
the SCCS, but the adoption of the directive
is not homogeneous over the Member
Countries. It must be highlighted that no
claim should be made that implies that a
“100% protection against UVA and UVB
radiation” is guaranteed and that
“reapplication of the product is
unnecessary” e.g. whole day protection.
Examples of recommended warnings:
• Do not stay too long in the sun while
using a sunscreen
• Re-apply frequently to maintain
protection, especially after sweating,
swimming or toweling
8. • The use of sunscreens is one way to
reduce the dangers from sun exposure
• Instructions for use to ensure that
sufficient quantity is applied, e.g.
pictogram, illustration, etc
• Over-exposure to the sun is a serious
health threat The following SPF
classifications are recommended
JAPAN The classification of sunscreens
as cosmetics simplifies the process for
these products, as a great part of the
requests are linked to the JCIA self-
regulating standards. The UV filters are
among the ingredients that are regulated.
The minimum SPF may even be as low as
just 2 while the maximum is 50+. The
request to add specific warnings such as
“reapply every 2-3 hours and reapply after
towelling” is still in discussion. Some
attention must be paid to claims like
“prevents wrinkles”, which is not
permitted, while the claim “prevents fine
lines caused by dryness of skin” may be
allowed provided it is substantiated by
testing.
CHINA The rapid change of the
regulatory profile for cosmetics is due to
many aspects: the growing market, the
needs of protection, the request for quality
exports and the change of the governing
body from MOH to the more structured
SFDA. China has approved many changes,
such as the approved ingredients list (now
under further revision) and has identified a
classification as “special use cosmetics”
for sunscreens. This means that
registration of a product with the State
Food and Drug Administration (SFDA)
will check the safety and efficacy of the
product, along with the SPF and other
parameters. The list of permitted filters is
the same as the EU, which is due to the
close exchange between the EU
commission and Chinese authorities
looking for harmonisation of regulations.
The maximum level is SPF 50 while for
UVA the rates are PA +, ++. +++. An
issue which is always in discussion is
China’s request (in general for cosmetics)
for animal testing and, in this case, the in-
vivo UVA mandatory testing.
HONG KONG Surprisingly, it is the
easiest country to register cosmetics in
since no specific rule is in place for
import, and customs normally require the
products to meet the regulations in one of
the “developed countries” e.g. EU, USA,
China, Australia.
KOREA Korea distinguishes different
classes of cosmetics (their system
resembles the Chinese regulations) and
classifies sunscreens as “Functional
Cosmetics” with specific provisions.
Products must be sampled for registration
and reports on test methods for both active
9. ingredients and finished products must be
provided. The dossier must include
information of the origin, development and
final formulation. The maximum allowed
SPF is 50+ and the result of SPF or
efficacy data and testing must be provided
by a test supervisor (similarly to the safety
assessor in EU regulations) with more than
5 years of experience. A specific process is
required for new sunscreen active
ingredients, which need to be supported by
a dossier that must include extensive
safety data. In Korea the manufacturer
must also provide all information on the
fragrance used, including a components
list of the fragrance.
TAIWAN Like many Far East Asian
countries, in Taiwan sunscreens are
classified as medicated cosmetics. This
means registration requires a GMP
certificate. The labelling regulations are
similar to other systems worldwide, with
the SPF numeric value (max 50+) and the
UVA protection grade that can be up to
PA ++++. The list of allowed filters is the
same as in the EU, but with different
allowed concentrations.
AUSTRALIA The sunscreen regulations
in Australia are full of important
requirements that reflect the high level of
attention towards sun protection in
Australia. This specific need is due to the
geographical and meteorological position
of this country. Sunscreens are classified
mainly as therapeutic and cosmetic
sunscreens (8). Therapeutic sunscreens
include:
• primary sunscreens with SPF 4 or more
• secondary sunscreens – except those
regulated as cosmetics
• primary or secondary sunscreens with
SPF 4 or more that contain an insect
repellent
• products containing sunscreen agents
with SPF less than 4 that are currently
defined as listable sunscreens (specific
situation to be checked in detail) Cosmetic
sunscreens are products that contain an
ingredient with sunscreen properties but
the primary purpose of the product is
neither to be a sunscreen nor a therapeutic
molecule. These products are regulated as
cosmetics by the National Industrial
Chemicals Notification & Assessment
Scheme (NICNAS) rather than therapeutic
goods, which are classified by the TGA.
Among the specific rules for Australia, a
norm regulates the allowed filters and their
amount, and there are a number of specific
rules for claims. These are different
between the two categories. Therapeutic
sunscreens with a broad spectrum
protection (SPF of 30 or higher) may have
these indications on the label:
10. • ‘May assist in preventing some skin
cancers.’
• ‘May reduce the risk of some skin
cancers.’
• ‘Can aid in the prevention of solar
keratoses.’
• ‘Can aid in the prevention of sunspots.’
In Australia nano titanium dioxide and
zinc oxide are commonly used in
sunscreens and the labels of therapeutic
sunscreens are not required to declare the
particle sizes of ingredients.
For the labelling of secondary sunscreens,
which limits the SPF to under 15 (and for
make-up up to 50+), a broad spectrum
activity is mandatory and the levels are as
usual - Low, Medium, High, Very High -
but there is a wider range of SPF values in
the low class (4, 6, 8, 10). NEW
ZEALAND In New Zealand sunscreens
are classified as cosmetics and the
standards for cosmetics is clearly linked to
the EU regulation, which is usually applied
(updated) as it is. Otherwise, the
recommendation is to market sunscreens
that comply with the Australian Standard
(AS/NZS 2604).
INDIA The cosmetic regulation in India
dates back to rather old regulations and the
marketing of products must deal with a lot
of bureaucracy (a typical statement you
can hear in India is that “the British
invented bureaucracy, the Indians
perfected it! “), in some cases with
standards and laws that conflict
themselves. Cosmetics in India must be
registered and the claims allowed refer to
water resistance, sunblock, broad spectrum
along with SPF value and the UVA
protection expressed as PA++. A specific
rule (9), recently passed, regards packaged
goods. Packaged goods require cosmetics
to bear a red or brown dot for non
vegetarian products and a green dot for
vegetarian products. The application is still
not very clear as there is no definition of
“vegetarian cosmetics”- this point has to
be checked during the registration process.
RUSSIA The growing market of Russia
has seen the regulations being updated
quite a lot. It has to be noted that there is a
common market known as the Single
Customs Union (10), which includes
Russia, Belarus and Kazakhstan.
Sunscreens are classified as cosmetics
according to the Technical Regulation for
the Safety of Cosmetic Products that
resembles the EU regulation. Registration
is obligatory according to the GOST
standards and allowed filters are in the
annex V of the regulation, which is similar
to the EU annex. Also the labelling has
guidelines similar to the EU regulations,
with a products required to show a
maximum SPF of 50+, the PA +++ and the
11. broad-spectrum feature. Due to the climate
conditions, products needs to be evaluated
for stability.
MERCOSUR As occurs in Europe,
Russia and Asia, South America also has a
Common Market Group. The
MERCOSUR includes Argentina, Brazil,
Paraguay and Uruguay and a technical
regulation establishing labelling and safety
requirements for sunscreens has been in
place since 2012 (even if the application in
some countries, namely Brazil, may be
different). According to regulations, a sun
product is a preparation intended to be in
contact with the skin and lips with the
objective of providing protection against
UVB and UVA radiation by dispersing or
reflecting the radiation. Products that
claim protection against UV radiation as
an added benefit rather than as their main
objective fall under the scope of the
regulation, too. The technical framework is
derived from the 2006 EU
recommendation and requires the sun
protection factor, the water resistance
feature and that UVA protection is at least
1/3 of the UVB. Products must be
registered, while labelling has a separate
set of rules. The sun protection factor is
marked as “FPS” or the words “Factor de
Protección Solar” plus the UVA logo. In
the case of products that have the
sunscreen protection as an added benefit
the minimum SPF must be 2 and FPUVA
also 2, while a specific warning is needed:
“this product is not a sunscreen”. Rules on
claims require that they do not contain
language suggesting total protection from
solar radiation nor can they be labelled
with statements claiming to provide 100
percent protection against UV radiation, or
stating that the product does not need to be
reapplied under any circumstances.
The definition “Broad Protection” is not
accepted. Specific warnings are (refer to
the EU recommendation) that
(1) sunscreens need to be reapplied to
maintain their effectiveness;
(2) they help prevent sunburn;
(3) a doctor should be consulted if applied
to children under six months;
(4) prolonged sun exposure by children
should be avoided; they do not provide any
protection against sunstroke;
(5) they should be applied abundantly
before sun exposure;
(6) they should be re-applied after
sweating profusely, bathing, swimming,
drying oneself with a towel and exposure
to the sun; and
(7) if the applied quantity is not sufficient,
the level of protection will be significantly
reduced.
12. Also the categories are the same of those
in Europe with Low, Medium, High, very
High, with the maximum SPF allowed
being 50+. It must be underlined that in
Brazil the list of allowed sunscreens is
broader than in the EU and in the US and
that for the cosmetic products the age limit
for children is up to 12 years old.
ISRAEL AND THE MIDDLE EAST
Laws in this area have recently undergone
many changes, with the basic structure of
the European regulation EC/1223/09 being
adopted to establish a system of local laws
and technical standards. Yet, due to many
bureaucratic burdens, each country had
previously gone through its own process of
developing regulations. However, the main
aspects related to the allowed filters and
SPF values are now the same.
ECUADOR Recently, this country has
adopted a specific standard that is mainly
based on regulation EC/1223/09, including
the technical part in the annexes.
TESTING Testing of sun care products is
according to local regulations and, due to
historical reasons, it can appear rather
complex. A more detailed description of
each standard would require more space
than this short overview allows.
Sun Protection Factor (UVB) The ISO
24444:2010 is in fact applied in Europe,
Israel, Canada, Mercosur, Mexico, Chile
and Andean, Australia, South Africa,
Korea, Taiwan, Asean and Russia. The US
FDA 2011 is accepted in USA, Canada,
Mercosur, Mexico, Chile and Andean,
Korea, China, Taiwan and ASEAN. China,
Korea and Mercosur have also their own
standards, but also accept others, so
hopefully in the future there will be only
one system. All systems provide a
measurement that can be used to label the
SPF value. With regard to UVA testing,
the situation is almost the same since we
can count on the ISO 24443 (or 24442)
and the corresponding US FDA broad
spectrum test from the 2011 monograph.
As for water resistance testing for
packaging claims (water proof is no longer
accepted), this is more diverse around the
world and mainly reflects the different
approach of each governing body - this
topic has substantial importance as it may
greatly affect the safety of consumers, as it
may offer the illusion of being protected
also while bathin
Cosmetic Sunscreens
Some products contain an ingredient with
sunscreening properties but the primary
purpose of the product is neither
sunscreening nor therapeutic. These
products are regulated as cosmetics by the
National Industrial Chemicals Notification
& Assessment Scheme (NICNAS) rather
than by the TGA as therapeutic goods. In
13. accordance with the Therapeutic Goods
(Excluded Goods) Order No. 1 of 2011,
these products are not regulated under the
Therapeutic Goods legislation and are not
required to be included in the ARTG. For
the purpose of these Guidelines such
products are called ‘cosmetic sunscreens’.
They may also be referred to as ‘excluded’
sunscreens. A cosmetic sunscreen product
must meet the definition of a cosmetic
under the Industrial Chemicals
(Notification and Assessment) Act 1989
and any requirements set out in the current
Cosmetics Standard and NICNAS
Cosmetics Guidelines. Requests for
regulatory information and enquiries about
cosmetic products should be directed to
NICNAS. Industrial Chemicals
(Notification and Assessment) Act 1989
defines
a. cosmetic as follows: ‘Cosmetic means:
a. substance or preparation intended for
placement in contact with any external part
of the human body, including:
i. the mucous membranes of the oral
cavity; and
ii. the teeth; with a view to
iii. altering the odours of the body
iv. changing its appearance
v. cleansing it;
vi. maintaining it in good condition
vii. perfuming it
viii. protecting it; or
b. substance or preparation prescribed by
regulations made for the purposes of this
paragraph; but does not include
c. therapeutic good within the meaning of
the Therapeutic Goods Act 1989
d. a substance or preparation prescribed
by regulations made for the purposes of
this paragraph.
The current Cosmetics Standard and the
associated NICNAS Cosmetics Guidelines
should be consulted for guidance on the
conditions applying to the following
secondary sunscreen products for them to
be regulated as cosmetics rather than
therapeutic goods: a. Make-up products for
the face and nails:
· tinted bases or foundation (liquids, pastes
or powders) with sunscreen
· products (tinted or untinted) intended for
application to the lips with sunscreen. b.
Skin care products:
· some moisturising products with
sunscreen for dermal application,
including antiwrinkle, anti-ageing and skin
whitening products
14. · some sunbathing products (for example,
oils, creams or gels, including products for
tanning without sun and after sun care
products).
The Cosmetics Standard and NICNAS
Cosmetics Guidelines include specific
requirements regarding the presentation
and labelling of cosmetic sunscreen
products. Sponsors are responsible for
ensuring that such products comply with
those requirements. Failure to comply with
those requirements may make the product
concerned a therapeutic good that must be
listed or registered in the ARTG. Other
mandatory requirements applying to the
labelling of all cosmetic products are set
out in Cosmetic & toiletries ingredient
labelling published by the Australian
Competition & Consumer Commission
(ACCC).
Regulatory Categories Of Sunscreens
Most therapeutic sunscreens marketed in
Australia are currently defined as ‘listable’
therapeutic goods which means that they
must be ‘listed’ in the ARTG. Other
sunscreen products must be ‘registered’ in
the ARTG, while others are exempt from
registration or listing (see below). General
information on listing and registration of
therapeutic goods is available on the TGA
Internet site.
Exempt Sunscreens
A therapeutic sunscreen product is
‘exempt’ under Item 8(g) of Schedule 5 of
the Regulations if:
· the SPF established by testing according
to AS/NZS 2604:2012 is less than 4, and ·
the label claims comply with AS/NZS
2604:2012, and
· the product does not have an indication
for the treatment of a serious disease,
condition, ailment or defect . Exempt
therapeutic sunscreens do not require
registration or listing in the ARTG, but are
treated as therapeutic goods in all other
respects and must comply with all relevant
parts of the Therapeutic Goods legislation,
including relevant standards such as the
Labelling Order (Therapeutic Goods Order
No. 69, and amendments) and the
Therapeutic Goods Advertising Code.
Listing Of Therapeutic Sunscreens The
majority of therapeutic sunscreen products
require listing in the ARTG in accordance
with Item 7 of Part 1 of Schedule 4 of the
Regulations. Information on the listing
process using the TGA’s Electronic
Listing Facility (ELF) and details of what
information needs to be provided for listed
products are provided in the Electronic
Listing Facility (ELF) User Guide. Under
Item 7 of Part 1 of Schedule 4 of the
Regulations, sunscreen products are
eligible for listing where they come within
15. the following description: ‘Sunscreen
preparations for dermal application (other
than preparations for the treatment of a
disease, condition, ailment or defect
specified in Part 1 or 2 of Appendix 6 to
the Therapeutic Goods Advertising Code),
if:
a. the claimed sun protection factor has
been established by testing according to
the method described in Standard AS/NZS
2604:2012, as in force from time to time;
and
b. the performance statements and
markings on the label comply with that
Standard; and
c. the sunscreen preparation only contains
ingredients that are specified in a
determination under paragraph 26BB(1) of
the Act; and
d. if a determination under paragraph
26BB(1) of the Act specifies requirements
in relation to ingredients being contained
in the sunscreen preparation—none of the
requirements have been contravened.
The SPF of therapeutic sunscreens must
be determined by testing on human skin in
accordance with the sunscreen standard
AS/NZS 2604:2012 which references the
International Organisation for
Standardisation procedure ISO
24444:2010 Cosmetics – Sun Protection
test methods – In vivo determination of
SPF (Sun Protection Factor). Note that,
where in vivo SPF test results have been
produced using the US FDA static SPF
test procedure described in FDA
Sunscreen Drug Products for OTC Human
Use: Final Monograph, the individual SPF
results may be used to calculate the mean
SPF and the label SPF provided they meet
the statistical criteria set out in ISO
24444:2010 as referenced in AS/NZS
2604:2012. Therapeutic sunscreen
products may only contain active
sunscreening ingredients that are included
in the list of sunscreening agents permitted
as active ingredients in therapeutic
sunscreens and are within the maximum
concentrations stated in the list. Sponsors
should consider the impact of excipients
on the sensitivity of the skin to sunlight
and should ensure that the finished product
is safe for its intended purpose. Sunscreen
products that make therapeutic claims
other than sunscreening (for example,
reduction of free radicals in or below the
skin, or claims relating to reduction of UV
induced immune suppression) and/or
contain active therapeutic ingredients that
are not included in the list of sunscreening
agents permitted as active ingredients (see
subsection 9.1) are not ‘listable sunscreen
preparations’ and must be registered in the
ARTG as OTC or prescription medicines
depending on the active ingredients
16. contained and therapeutic claims made
Subsection 4.1 lists the therapeutic claims
permitted for listed sunscreens. Australian
regulatory
Registration Of Therapeutic Sunscreens
Sunscreens that are not ‘listable’, ‘exempt’
or ‘cosmetic’ (excluded) are evaluated by
the TGA for quality, safety and efficacy as
registered therapeutic goods under section
25 of the Act. Data to support the quality,
safety and efficacy of such products are
required as detailed under the relevant
chapters of the Australian Regulatory
Guidelines for OTC Medicines (ARGOM).
Products in this category include:
products that contain a sunscreen
active ingredient that is not
included in the list of sunscreening
agents permitted as active
ingredients (see subsection 9.1)
products that make any therapeutic
claims other than the sunscreening
claims permitted under section 4
‘Labelling and advertising’, or that
are for the treatment of a disease,
condition, ailment or defect
specified in Part 1 or 2 of
Appendix 6 of the Therapeutic
Goods Advertising Code
products that contain substances
that are scheduled in the SUSMP
products that contain a
sunscreening active ingredient
combined with a claimed
therapeutic active ingredient that is
not a permissible active ingredient
in a listed medicine in accordance
with section 26BB of the Ac
products that are not otherwise
‘listable’, ‘exempt’ or ‘excluded’.
Responsibility Of Sponsors To
Report Adverse Reactions
It is a standard condition of listing
or registration of a medicine that
the sponsor has an appropriate
system of pharmacovigilance and
that the sponsor reports to the TGA
adverse reactions experienced by
users of the sponsor’s products.
This requirement applies to
sponsors of therapeutic sunscreens.
Details of the TGA’s requirements
for pharmacovigilance and the
reporting of adverse reactions can
be found on the TGA Internet site.
Labelling and advertising
The labelling and advertising of
therapeutic sunscreen products
included in the ARTG must
comply with the relevant
requirements of each of the
following:
17. the Labelling Order,
Therapeutic Goods Order No
69 (or any subsequent order
amending or replacing TGO
69)
the Therapeutic Goods
Advertising Code (as updated
from time to time)
the Australian/New Zealand
Standard AS/NZS 2604:2012
Sunscreen products –
Evaluation and classification
the current edition of Required
Advisory Statements for
Medicine Labels (RASML). A
check list is provided at the
end of this document
(Appendix 1) to assist
sponsors in designing their
sunscreen labels in accordance
with the requirements of the
documents listed above.
However, the check list is not
exhaustive and sponsors are
responsible for ensuring that
their labelling complies with
all of the relevant legislative
requirements. TGO 69, the
Therapeutic Goods
Advertising Code and the
RASML do not apply to
cosmetic sunscreens.
General
As required by sections 2 and
3 of the Labelling Order (TGO
69), the label (or labels) must:
· be printed on or firmly and
securely attached to the
container
· be unlikely to become
detached or defaced or
illegible during use
· be positioned so that it will
not be damaged or
removed when the
container is opened
· not be obscured by any
other label or object
· be printed in English
· be printed in lettering that
is clear, distinct and
legible, and the height of
letters with ascenders or
descenders is not less than
1.5 mm (except for the
AUST L or AUST R
number, which may be 1
mm high).
As prohibited by section 4 of
the Therapeutic Goods
Advertising Code, the labelling
must be free from claims,
statements or pictures that: ·
are likely to arouse
unwarranted and unrealistic
18. expectations of the product’s
effectiveness · are false,
unbalanced, unsubstantiated,
misleading or likely to mislead
the user · abuse the trust or
exploit the lack of knowledge
of consumers or contain
language that could bring
about fear or distress ·
encourage or are likely to
encourage inappropriate use ·
indicate or imply that the
product is infallible, unfailing,
magical, miraculous, or
effective in all cases · indicate
or imply that the product
cannot cause harm Australian
regulatory guidelines for
sunscreens V1.1 January 2016
Page 12 of 43 Therapeutic
Goods Administration ·
indicate or imply that other
competitor products are
harmful or ineffectual ·
indicate or imply that the
product is endorsed by any
government agency, hospital
or other facility providing
healthcare services, individual
healthcare professional or
group of healthcare
professionals. Therapeutic
sunscreens that are ‘listable’
are permitted to carry the
following coded indications
provided that the sunscreen
meets the requirements of
AS/NZS 2604:2012 for the
indications designated:
1. A broad spectrum sunscreen
with an SPF of 30 or higher is
permitted to carry the
following indications:
· ‘May assist in preventing
some skin cancers.’
· ‘May reduce the risk of
some skin cancers.’
· ‘Can aid in the prevention
of solar keratoses.’
· ‘Can aid in the prevention
of sunspots.’
2. A broad spectrum sunscreen
with an SPF of 4 or higher is
permitted to carry the
following indication:
· ‘Can aid in the prevention
of premature skin ageing.’
In principle, indications
considered appropriate for
listed sunscreens are those that
can be used safely and
effectively without the
intervention of a healthcare
practitioner. For medicines
generally this includes
diseases, disorders or
conditions that are normally of
19. a benign or selflimiting nature
that the average consumer can
be expected to evaluate or
diagnose accurately. Some
indications that relate to a
serious disease condition,
ailment or defect such as skin
cancer are restricted except
those allowed above which
have been approved by the
TGA for therapeutic
sunscreens. The Act requires
that, at the time of listing a
medicine in the ARTG, a
sponsor must certify that it
holds the information or
evidence to support indications
and claims made in relation to
the product. All indications
and claims must be capable of
substantiation – that is,
evidence held by the sponsor
must adequately demonstrate
all indications and claims
made for the product are true,
valid and not misleading.
Listed medicines are not
subject to pre-market
evaluation for efficacy at the
time of listing. However, data
supporting the indications may
be requested by the TGA for
review after listing of a
medicine. Hence, the TGA
may request copies of labelling
and the results of pre-market
SPF, broad spectrum
performance, water resistance
or stability testing. If
requested, it is expected that
this information will be
available and can be provided
to the TGA within a
reasonable time of the request.
Therapeutic sunscreens may
also carry justified non-
therapeutic claims (for
example, ‘contains Vitamin E’,
‘contains aloe vera’,
‘moisturising’, ‘antioxidant’,
‘free radical barrier’) and
information to support such
claims may be requested by
the TGA for review. If the
certification by the sponsor
that it holds this information or
evidence is incorrect, the TGA
can cancel the listing of the
product from the ARTG. The
labelling may also carry
company logos, other symbols
and consumer information
provided these do not create
confusion for Australian
consumers and they do not
conflict with the requirements
of the Therapeutic Goods
legislation, the Labelling
20. Order, the Sunscreen Standard
or the Advertising Code.
Labelling Of Immediate
Container And Primary
Pack
· As required by subsection
3(2) of the Labelling Order
and section 7 of the
Sunscreen Standard
AS/NZS 2604:2012, the
main label on the container
and the main label of the
primary pack (for example,
carton), if any, must
contain all of the following
information:
· the product name Note:
The use of the term
‘sunblock’ is not
acceptable as part of a
product name (or
elsewhere on the label).
· The term is a misnomer
because sunscreens filter to
varying degrees but do not
completely block the
sunburning radiation.
· the name of the dose form,
for example, ‘cream’ or
‘lotion’
· the sun protection factor
(SPF) of the product
preceded by the expression
‘Sun Protection Factor’ or
‘SPF’ marked in durable
and legible characters and
in such colour or colours as
to afford a distinct contrast
to the background colour
and in letters not less than
1.5mm in height Note: A
category description may
also be given, for example,
‘low / medium or moderate
/ high / very high
protection’.
· [if relevant] the water
resistance of the product
(in hours or in minutes)
established in accordance
with AS/NZS 2604:2012
Note: The use of the terms
‘waterproof’ and ‘sweat
proof’ are not acceptable.
Sunscreens may be water
resistant but none are
completely waterproof, and
even those with a high
water resistance rating will
gradually wash off the skin
when immersed in water
for long enough or through
perspiration.
· the statement ‘broad
spectrum’ in letters not
larger than those used for
the SPF provided that the
21. product meets the criteria
of broad spectrum
protection from UV (or
UVA and UVB) light as
defined and measured by
AS/NZS 2604:2012
· the net quantity of the
goods (by volume in mL or
weight in g) · the ARTG
listing number preceded by
‘AUST L’ or registration
number preceded by
‘AUST R’. Note: If the
container is packed in an
outer carton the listing or
registration number must
be on the main label of that
carton and may be, but is
not required to be, on the
container as well. All of
the following information
must be included either on
the main label or on a rear
or side panel [see
subsection 3(3)(c) of the
Labelling Order]:
· the names of all
sunscreening active
ingredients expressed using
Australian Approved
Names (AAN) Note:
International Nomenclature
of Cosmetic Ingredients
(INCI) names may also be
included in addition to (but
not as a substitute for) the
AANs.
· the proportions of those
ingredients either
expressed as a percentage
in terms of w/w or w/v or
expressed as a weight in a
stated weight or volume of
the product using metric
units of measurement (for
example, mg/g or mg/mL).
All of the following
information must be
included somewhere on the
label(s) or container:
· the recommended storage
conditions ‘store below
25°C’ or ‘store below
30°C’, as applicable
· the batch or lot number of
the product, preceded by
the batch number prefix
using one of the formats
specified in subsection 2(1)
of the Labelling Order
Nanoparticles In
Sunscreens
Nanoparticulate titanium
dioxide and zinc oxide are
commonly used in
sunscreens. The labels of
therapeutic sunscreens are
not required to declare the
22. particle sizes of
ingredients. The TGA’s
policy on the safety of
nanoparticulate ingredients
in sunscreens is available
from the TGA Internet site
Reproducibility Of SPF
Test Results
The in vivo testing of the
SPF of a sunscreen product
according to the procedure
in ISO 24444:2010 and
AS/NZS 2604:2012
produces a reasonable
estimate, but not a highly
accurate and precise
measure, of the true SPF of
the product applied to the
skin at a rate of 2 mg/cm2.
The test data exhibit a
considerable inherent
variance which needs to be
taken into account when
interpreting the test results
and labelling of the
product, and also needs to
be taken into account when
interpreting the results of
any subsequent retesting of
the product. The test
procedure in ISO
24444:2010 and referenced
by AS/NZS 2604:2012
requires the product to be
tested on a minimum of 10
subjects and for the
arithmetic mean, standard
deviation and 95%
confidence interval (95%
CI) for the mean to be
calculated using the
formula 95% CI = m ±
t.s/√n, where
‘n’ is the number of
individual SPF data,
‘m’ is the arithmetic mean
of those data,
‘t’ is the value of Student’s
t for n-1 degrees of
freedom and p=0.05
(double sided), and
‘s’ is the standard
deviation of the test data.
There is a 95% probability
that the true SPF of the
product lies somewhere
within the 95% CI.
For the test to be
considered valid, the 95%
CI must fit within ± 17%
of the mean and, if not, the
product must be tested on
further subjects (up to a
maximum of 20) until the
95% CI based on the data
for all subjects does fit
within ± 17% of the mean.
If testing on 20 subjects
23. does not bring the 95% CI
within ± 17% of the mean
the whole test must be
rejected. In practice, use of
more than 10 subjects
would be necessary only if
the coefficient of variation
(CV = s/m) is greater than
24%, and testing on 20
subjects would only fail if
the CV was greater than
37%. Statistical analysis of
the SPF test data submitted
to the TGA over recent
years in support of SPF
claims made for a large
range of sunscreen
products has shown that
the data typically exhibit a
relative standard deviation
(RSD) or coefficient of
variation (CV) in the range
5–20%. Only rarely is the
CV less than 5% or greater
than 20%. Thus, in the
majority of cases, testing
on 10 subjects would yield
a 95% CI well within the
±17% limits and testing on
additional subjects would
not be required.
Subsequent retesting of a
sunscreen is likely to yield
a mean SPF anywhere
within the 95% CI from the
original testing of the
product or even a few SPF
units beyond either end of
that 95% CI.
Consequently, if the
original test result was
close to the lower limit for
a particular SPF claim
allowed by the Standard,
the retest result could be
lower than that lower limit
and appear to cast doubt on
the validity of the labelled
SPF claim. However, it
would be necessary to
retest the product several
times and obtain
consistently low mean
results before any
conclusion could be drawn
about the labelled SPF
being unjustified.
Stability Test
Requirements
Therapeutic sunscreens
marketed in Australia must
be labelled with an ‘expiry’
or ‘use by’ date. That date
must be supported by
experimental data that
support the shelf life of the
sunscreen product in the
container intended for
24. marketing (or at least a
container made of the same
materials and with similar
shape, size and wall
thickness to that of the
market container) under
the recommended storage
conditions (that is, ‘Store
below 25°C’ for product to
be stored in airconditioned
premises or ‘Store below
30°C’ for product to be
stored at room
temperature). The data
must substantiate the
physical, chemical and
microbiological stability of
the product for at least the
claimed shelf life.
Sponsors of all therapeutic
sunscreen products are
expected to have
performed stability testing
on each product to at least
the standard set out in
these Guidelines. The
claimed shelf life and
storage conditions for each
product should be derived
from the results of the
stability testing on that
product. Generation of
adequate stability data to
support the assigned shelf
life for a therapeutic
sunscreen is the
responsibility of the
sponsor. While the stability
data supporting the shelf
life of a sunscreen product
are not required to be
submitted to the TGA at
the time of listing, they
may be requested for
review by the TGA at any
time. Sponsors should,
therefore, ensure that the
data are available in a form
suitable for submission to
the TGA if and when
requested. Stability testing
guidelines for sunscreens,
Guidelines for Stability
Testing of Sunscreens
April 1994, were
developed by the
Australian industry peak
bodies and accepted by the
TGA. They are now
incorporated below with
some minor amendments
to improve clarity and
consistency with the
stability guidelines for
medicines adopted by the
TGA (see ARGOM
chapter on Quality). This
section (7) now supersedes
25. the Guidelines for Stability
Testing of Sunscreens
April 1994.
Shelf Life Determination
For a product exhibiting no
discernable changes or
trends, a 2-year shelf life
for storage conditions of
‘store below 30°C’ (that is,
storage at room
temperature in Australia)
may be supported by
stability data covering 6
months storage at 40°C,
and a 3-year shelf life for
storage conditions of ‘store
below 30°C’ may be
supported by data covering
either 9 months at 40°C or
6 months at 45°C. A shelf
life of greater than 3 years
should be supported by
data from storage at 40°C
covering at least half of the
shelf life (for example, 2.5
years accelerated data
would be required to
support a 5-year shelf life).
For a product exhibiting no
discernable changes or
trends, a 2-year shelf life for
storage conditions of ‘store
below 25°C’ (that is, the
product should be stored in
air-conditioned premises)
may be supportedbystability
data covering 6 months
storage at 35°C, and a 3-year
shelf life for storage
conditions of ‘store below
25°C’ may be supported by
data covering either 9
months at 35°C or 6 months
at 40°C. A shelf life of greater
than 3 years should be
supported by data from
storage at 35°C covering at
least half of the shelf life.
Generally, the maximum
shelf life permitted for any
therapeutic good is 5 years.
26. CONCLUSION
As stated above, it’s not possible to
provide detailed information on sunscreens
regulations in a few pages, as each
geographic area has its peculiarities. In the
case of sunscreens, regulatory departments
and the R&D must cooperate at a very
early stage of the project for a new product
(this is recommended anyway) in order to
clearly identify the boundaries, potential
problems and solutions. Given the variety
of situations, it’s certainly not easy to
claim to have an internationally-accepted
formula and it may be better to have a
framework structure with a standard set of
filters one can adapt to each situation.
R&D must maintain enough flexibility
during development to adapt the formula
in case of changes to rules and the
regulatory affairs department should be
able to spot changes to laws as soon as
they are enforced. Certainly, the ability of
a company to develop a sunscreen that is
successful when placed on the global
market is a difficult task and, when
achieved, shows the skills of the people
that work there.
REFERENCES AND NOTES
1. The list is wide and the citations are
only given as an example, every ingredient
you can search on Google may have some
issue, simply check the www.ewg.org
2. Giulio Pirotta - How to classify
cosmetics - A complete guide to classify
Temperature above
labeled storage
conditions
Time period Test time
points
Possible shelf life prediction
+10°C 6 months 0, (1 or 2), (3 or
4), 6 months
2 years
+10°C 9 months 6,9 months 3years
+15°C 6 months 6 months 3years
27. and description of cosmetic products – in
press
3. REGULATION (EC) No 1223/2009 OF
THE EUROPEAN PARLIAMENT AND
OF THE COUNCIL of 30 November 2009
on cosmetic products
4. COMMISSION RECOMMENDATION
of 22 September 2006 on the efficacy of
sunscreen products and the claims made
relating thereto (2006/647/EC)
5. 21 CFR Parts 201 and 310 Labeling and
Effectiveness Testing; Sunscreen Drug
Products for Over-the- Counter Human
Use Federal Register/ Vol. 7
6, No. 117 / Friday, June 17, 2011 / Rules
and Regulations 6.
http://www.accessdata.fda.gov/scripts/cdrh
/cfdocs/cfcfr/
CFRSearch.cfm?CFRPart=352
7. Brunei, Cambodia, Indonesia, Laos,
Malaysia, Myanmar, Philippines,
Singapore, Thailand, Viet Nam
8. Version 1.0 13 November 2012 The
Australian regulatory guidelines for
sunscreens (ARGS)
9. GSR 137 of 17 June 2014
10. The Customs Union Commission
(Decree No. 526 of 28.01.2011)