Commission Recommendation of 22 September 2006 on the efficacy of sunscreen products and the claims made relating thereto (notified under document number C(2006) 4089)   (Text with EEA relevance)
Date: 2006-09-22
Institutions: European Commission
Subjects: consumer information, consumer protection, cosmetic product, health risk, labelling

26.9.2006

EN

Official Journal of the European Union

L 265/39

COMMISSION RECOMMENDATION

of 22 September 2006

on the efficacy of sunscreen products and the claims made relating thereto

(notified under document number C(2006) 4089)

(Text with EEA relevance)

(2006/647/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

cations of the provisions laid down in Article 6(3) of
Directive 76/768/EEC for claims made in respect of the
efficacy of sunscreen products.

establishing the European
Having regard to the Treaty
Community, and in particular the second indent of Article
211 thereof,

Whereas:

(1)

(2)

(3)

(4)

of Article

Sunscreen products are cosmetic products within the
meaning
Council Directive
1(1)
76/768/EEC of 27 July 1976 on the approximation of
the laws of
the Member States relating to cosmetic
products (1).

of

cosmetic

the first paragraph of Article 2 of Directive
Under
76/768/EEC,
the
products
Community market must not cause damage to human
health when applied under normal or reasonably fore-
seeable conditions of use, taking account, in particular, of
the product’s presentation,
any
instructions for its use.

labelling

placed

and

on

its

Article 6(3) of Directive 76/768/EEC obliges Member
States to take all measures necessary to ensure that, in
the labelling, putting up for sale and advertising of
cosmetic products,
trade marks, pictures
and figurative or other signs are not used to imply that
these products have characteristics which they do not
have.

text, names,

is manufactured or

Moreover, under Article 7a of Directive 76/768/EEC, the
manufacturer or his agent or the person to whose order
a cosmetic product
the person
responsible for placing an imported cosmetic product
on the Community market must, for control purposes,
keep information on the proof of the effect claimed for
the cosmetic product, where justified by the nature of the
effect or product, readily accessible to the competent
authorities of the Member State concerned.

(5)

In order
to contribute to a high level of health
protection, guidance should be given as to the impli-

(1) OJ L 262, 27.9.1976, p. 169. Directive as last amended by
Commission Directive 2006/65/EC (OJ L 198, 20.7.2006, p. 11).

(6) While industry has already made certain efforts in this
respect, it is appropriate to set out examples of claims
which should not be made in relation to sunscreen
should be observed, and
products, precautions
usage instructions
should be recommended for
some of the characteristics claimed.

that

that

(7)

(8)

(9)

(10)

It is also appropriate to address certain other aspects
relating to claims made for sunscreen products and the
efficacy of such products, namely the minimum efficacy
of a sunscreen product in order to ensure a high level of
protection of public health and how the labelling of
sunscreen products can be kept simple and compre-
hensible in order to assist the consumer in choosing
the appropriate product.

Sun radiation consists inter alia of (shorter) ultraviolet B
radiation (‘UVB radiation’) and of (longer) ultraviolet A
radiation (‘UVA radiation’). The inflammation of the skin
(‘sun burn’) and the resulting reddening of
the skin
(erythema) is mainly caused by UVB radiation. As to the
cancer
the main
although UVB radiation is
contributor, the risk generated through UVA radiation
cannot be neglected. Furthermore, UVA radiation is
cause of premature ageing of the skin. Research also
suggests that excessive exposure to UVB radiation as
well as UVA radiation impacts on the body's immune
system.

risk,

can be

effective

Sunscreen products
in preventing
sunburn. Scientific findings also suggest that sunscreen
products can prevent the damage linked to photo-ageing
and that
induced photo-
immunosuppression. Epidemiological studies show that
the use of sunscreen products may prevent some types
of skin carcinoma.

they can protect against

to have

these preventive

In order
characteristics,
sunscreen products need to protect against both UVB
and UVA radiation. Therefore,
sun
protection factor refers only to protection against the
radiation which causes erythema (mainly UVB radiation),
sunscreen products should contain both UVB and UVA
protection.

although the

L 265/40

EN

Official Journal of the European Union

26.9.2006

(11)

(12)

Even sunscreen products which are very effective and
which address both UVB and UVA radiation cannot
guarantee full protection against healthrisks from ultra-
violet (UV) radiation. No sunscreen product can filter all
UV radiation. Moreover, there is, to date, no conclusive
scientific evidence that the use of sunscreen products
prevents melanoma. Consequently, sunscreen products
should not claim or create the impression that
they
provide total protection from the risks deriving from
over-exposure to UV radiation.

(16)

exposure

This holds particularly true for sun exposure of babies
to sun during
and young children. As
to the devel-
childhood is an important contributor
sunscreen
opment of
skin cancer
products
they
provide sufficient protection for babies and young
children.

should not give the impression that

a later

age,

at

broad protection, dermatologists recommend a critical
wavelength of at least 370 nm.

In order to ensure reproducibility and comparability of
the recommended minimum protection against UVB
radiation,
the International Sun Protection Factor Test
Method (2006) as updated in 2006 by the European,
Japanese, American and South African industry should
be used.
In order to assess the minimum protection
against UVA radiation, the persistent-pigment darkening
method as applied by the Japanese industry and modified
by the French health agency Agence française de sécurité
sanitaire des produits de santé — Afssaps as well as the
critical wavelength test should be used. These testing
European
methods
Committee
to
establish European standards in this field (1).

been submitted
for Standardisation (CEN)

the
in order

have

to

(13) Mistaken perceptions of the characteristics of sunscreen
addressed through appropriate

should be

products
warnings.

(14)

(15)

the sun protection factor claimed.

Based on several studies, the International Agency for
Research on Cancer of the World Health Organisation
has emphasised the importance of the link between the
correct application of sunscreen products and the efficacy
of
In particular,
frequent re-application of sunscreen products is crucial.
Moreover, in order to reach the protection level indicated
by the sun protection factor, sunscreen products have to
be applied in quantities similar to the ones used for
i.e. 2 mg/cm2, which equals 6 teaspoons of
testing,
lotion (approx. 36 grams) for the body of one average
adult person. This quantity is higher than that usually
applied by the consumers. Applying a smaller quantity
to a disproportionate
of
leads
reduction in protection. For example,
the quantity
applied is reduced by half, protection may fall by as
much as two-thirds.

sunscreen product

if

sufficiently

effective
should be
Sunscreen products
against UVB and UVA radiation to ensure a high
protection of public health. To this end, a sunscreen
product should provide a minimum UVB and UVA
protection. An increased sun protection factor
(i.e.
mainly UVB protection) should include an increase in
the UVA protection as well. Therefore, the protection
against UVA and UVB radiation should be related.
Scientific findings show that certain biological damage
to the skin can be prevented and reduced if the ratio
the protection factor measured in the persistent
of
pigment darkening test
(i.e. addressing mainly UVA
radiation) is at least 1/3 of the factor measured by the
testing method (i.e. addressing
sun protection factor
in order to ensure a
mainly UVB radiation). Moreover,

(17) While these testing methods should be used as reference
methods, preference should be given to in vitro testing
methods delivering equivalent results, as in vivo methods
raise ethical concerns. Industry should increase efforts to
develop in vitro testing methods for the protection against
both UVB and UVA radiation.

(18)

Claims concerning the efficacy of sunscreen products
should be simple, meaningful and based on identical
criteria in order
to compare
products and to choose the right product for a given
exposure and skin type.

to help the consumer

(19)

There is in particular a need for a uniform claim on UVA
protection in order
the
consumer for a product protecting against both UVB
and UVA radiation.

to facilitate the choice of

(20) A wide variety of numbers used on labels for indicating
the sun protection factor does not support the aim of
making claims that are simple and meaningful. The
increase in protection from one number to the next is
negligible, particularly in the high range. Moreover, the
increase in protection is only linear in the case of
sunburn, that is to say, a product with sun protection
factor 30 protects twice as well from sunburn as product
with a sun protection factor of 15. However, a product
with sun protection factor 15 absorbs 93 % of UVB
radiation, and a product with sun protection factor 30
absorbs 97 % of UVB radiation. Finally, sun protection
factors above 50 do not
substantially increase the
protection from UV radiation. Therefore, the range of
labelled sun protection factors can be made smaller
without reducing the choice of different strengths for
the consumer.

(1) Standardisation mandate addressed to CEN on methods for testing
efficacy of sunscreen products, Mandate M/389, 12 July 2006.

26.9.2006

EN

Official Journal of the European Union

L 265/41

(21)

four

categories

(‘low’,
Labelling using one out of
‘high’ and ‘very high’), provides for a simpler
‘medium’,
and more meaningful
the efficacy of
indication of
sunscreen products than a variety of different numbers.
the category should be labelled at least as
Therefore,
prominently as the sun protection factor.

(c)

‘UVB radiation’ means sun radiation in the spectrum
290-320 nm;

(d)

‘UVA radiation’ means sun radiation in the spectrum
320-400 nm;

(22)

Consumers should be informed about the risks stemming
from excessive sun exposure. Moreover, consumers need
guidance as to the appropriate sunscreen product
in
terms of
its efficacy taking into consideration the
degree of sun exposure and the skin type,

(e)

‘critical wavelength’ means the wavelength for which
the section under the integrated optical density curve
starting at 290 nm is equal to 90 % of the integrated
section between 290 to 400 nm;

HEREBY RECOMMENDS:

(f)

‘minimum erythemal dose’ means
erythema-effective energy;

the quantity of

SECTION 1

SUBJECT MATTER AND DEFINITIONS

1. This Recommendation gives guidance on the following:

(g)

‘sun protection factor’ means the ratio of minimum
erythemal dose on skin protected by a sunscreen
product to the minimum erythemal dose on the same
unprotected skin;

(a)

in Section 2, on the application of Article 6(3) of
Directive 76/768/EEC in relation to some of the char-
acteristics of sunscreen products and the claims made
as regards their efficacy;

(b) in Sections 3, 4 and 5, on the minimum efficacy of
sunscreen products in terms of ensuring a high level of
protection against UVB and UVA radiation and on the
simple and comprehensible
sunscreen
products in order to facilitate the choice of the appro-
priate product for the consumer.

labelling of

2. For the purposes of this Recommendation, the following

definitions apply:

(a)

‘sunscreen product’ means any preparation (such as
creams, oils, gels, sprays)
intended to be placed in
contact with the human skin with a view exclusively
from UV radiation by
or mainly to protecting it
absorbing, scattering or reflecting radiation;

(h) ‘UVA protection factor’ means

ratio of

the
minimum UVA dose necessary to induce a persistent
pigment darkening on the
skin protected by a
the minimal UVA dose
product
sunscreen
necessary to induce the minimal darkening effect on
the same unprotected skin.

the

to

SECTION 2

UVA/UVB PROTECTION, CLAIMS, PRECAUTIONS FOR
USE, USAGE INSTRUCTIONS

3. The characteristics and claims referred to in points 4 to 8
should be considered for the purposes of complying with
Article 6(3) of Directive 76/768/EEC.

4. Sunscreen products should protect against both UVB and

UVA radiation.

5. No claim should be made that implies the following char-

acteristics:

(b) ‘claim’ means any statement regarding the character-
istics of a sunscreen product
text,
names, trade marks, pictures and figurative or other
signs used in the labelling, putting up for sale and
advertising of sunscreen products;

in the form of

(a) 100 % protection from UV radiation (such as

‘sunblock’, ‘sunblocker’ or ‘total protection’);

(b) no need to re-apply the product under any circum-

stances (such as ‘all day prevention’).

L 265/42

EN

Official Journal of the European Union

26.9.2006

6. Sunscreen products should display warnings indicating that
they do not provide 100 % protection and advice on
precautions to be observed in addition to their use. This
may include warnings such as:

10. The minimum degree of protection provided by sunscreen

products should be as follows:

(a)

‘Do not stay too long in the sun, even while using a
sunscreen product’;

(a) a UVB protection of sun protection factor 6 as obtained
in application of the International Sun Protection Factor
an equivalent degree of
Test Method
protection obtained with any in vitro method;

(2006) or

(b) ‘Keep babies and young children out of direct sunlight’;

(c)

‘Over-exposure to the sun is a serious health threat’.

(b) a UVA protection of UVA protection factor of 1/3 of
the sun protection factor, as obtained in application of
the persistent pigment darkening method as modified by
the French health agency Agence française de sécurité
sanitaire des produits de santé – Afssaps or an equivalent
degree of protection obtained with any in vitro method;

7. Sunscreen products should carry instructions for use that
will ensure that the claim made for the effectiveness of the
product can be achieved. This may include instructions
such as:

(c) a critical wavelength of 370 nm, as obtained in appli-
cation of the critical wavelength testing method.

(a)

‘Apply the sunscreen product before exposure’;

SECTION 4

(b) ‘Re-apply frequently to maintain protection, especially

after perspiring, swimming or towelling’.

8. Sunscreen products should carry instructions for use to
ensure that a sufficient quantity is applied on the skin to
achieve the effectiveness claimed for the product. This may
be done, for example, by indicating the quantity required
through a pictogram, an illustration or a measurement
device. Sunscreen products should carry an explanation of
the risks involved in applying a reduced quantity, such as,
‘Warning: reducing this quantity will
lower the level of
protection significantly’.

SECTION 3

MINIMUM EFFICACY

9. Sunscreen products should provide for a minimum degree
of protection against UVB and UVA radiation. The degree
of protection should be measured using standardised,
reproducible testing methods and take photo-degradation
into account. Preference should be given to in vitro
testing methods.

SIMPLE AND MEANINGFUL CLAIMS OF EFFICACY

11. Claims indicating the efficacy of sunscreen products should
be simple, unambiguous and meaningful and based on
standardised, reproducible criteria.

12. Claims indicating UVB and UVA protection should be
made only if the protection equals or exceeds the levels
set out under point 10.

13. The efficacy of sunscreen products should be indicated on
the label by reference to categories such as ‘low’, ‘medium’,
‘high’ and ‘very high’. Each category should be equivalent to
a standardised degree of protection against UVB and UVA
radiation.

14. The variety of numbers used on labels for indicating the
sun protection factors should be restricted in order to
comparison between different products
facilitate
the consumer. The
without
following range of
each
category and the respective labelling is recommended:

for
sun protection factors

the
reducing the choice

for

26.9.2006

EN

Official Journal of the European Union

L 265/43

Labelled category

Labelled sun
protection factor

Measured sun protection
factor (measured in
accordance with the
principles recommended
in point 10 (a))

Recommended minimum UVA
protection factor
(measured in accordance with
principles recommended in
point 10 (b))

Recommended minimum
critical wavelength
(measured in accordance with
principles recommended in
point 10 (c))

‘Low protection’

‘Medium
protection’

‘High
protection’

‘Very high
protection’

‘6’

‘10’

‘15’

‘20’

‘25’

‘30’

‘50’

6-9,9

10-14,9

15-19,9

20-24,9

25-29,9

30-49,9

50-59,9

‘50 +’

60 ≤

r
o
t
c
a
f

n
o
i
t
c
e
t
o
r
p

n
u
s

d
e
l
l
e
b
a
l

f
o

3
/
1

m
n

0
7
3

15. The category of sunscreen products should be indicated on the label at least as prominently as the sun

protection factor.

SECTION 5

CONSUMER INFORMATION

16. Consumers should be informed about the risks associated with excessive exposure to UV radiation and
of the category of sunscreen products required for a certain degree of sun exposure and a certain type
of skin. This may be done, for example, through information on national web-sites, leaflets or press
releases.

17. This Recommendation is addressed to the Member States.

SECTION 6

ADDRESSEES

Done at Brussels, 22 September 2006.

For the Commission

Günter VERHEUGEN
Vice-President