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Monographic special issue: Sun care - H&PC Today - Household and Personal Care Today - vol. 10(4) - July/August 2015
GIULIO PIROTTA
Senior Consultant, Neovita, Uboldo, VA, Italy
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.
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 and 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 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
An overview of sunscreen regulations
in the world
Giulio Pirotta
REVIEW
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Monographic special issue: Sun care - H&PC Today - Household and Personal Care Today - vol. 10(4) - July/August 2015
and octyl triazone approved in the US market is still 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%
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.”
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 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 labelling
• 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,
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Monographic special issue: Sun care - H&PC Today - Household and Personal Care Today - vol. 10(4) - July/August 2015
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 towelling
• 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
The typical label for a sunscreen is depicted in Figure 1.
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
Figure 1. Drug Facts labeling
Table 1. NHP
Medicinal
Ingredients,
Source
Ingredients and
Concentrations
Table 2. Drug Medicinal Ingredients, Synonyms and Concentrations
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:
• ‘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).
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 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
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Monographic special issue: Sun care - H&PC Today - Household and Personal Care Today - vol. 10(4) - July/August 2015
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 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.
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
Table 3. Permitted active ingredients for therapeutic sunscreens.
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Monographic special issue: Sun care - H&PC Today - Household and Personal Care Today - vol. 10(4) - July/August 2015
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 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.
76, 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)
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; (4) 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.
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 bathing.
Table 4. Summary table of SPF labels.
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