The Collegiate Board of Directors of the National Sanitary Surveillance
Agency, in the use of the attributions vested in it under Article
11, item IV, of the ANVISA Regulation approved by Decree nº
3.029 dated 16 April 1999 c/w Article 111, item I, letter “b”,
§ 1 of the Internal Regulation approved by Presidential
Decree nº 593, dated 25 August 2000, republished on 22
December 2000, in meeting held on 19 November 2003,
WHEREAS
Law nº 9782 dated 26 January 1999, that determines the
regulation, monitoring and inspection of products and services
that involve a risk to public health;
Law nº 9294 dated 15 July 1996;
Federal Law nº 10167 dated 27 December 2000;
Resolution - RDC nº 46 dated 28 March 2001;
Provisional Measure nº 2134-30 dated 24 May 2001;
Law nº 10702 dated 14 July 2003;
the significant increase of tobacco smoking that caused the
loss of at least 3.5 million lives throughout the world in 1998,
with an estimated loss of 10 million lives per year by 2030,
70% of which in developing countries,
the images that illustrate the warning messages need to be
periodically updated,
has adopted the following Resolution, applicable to all smoking
tobacco-derived products and marketed in the Brazilian territory,
whether produced locally or imported, and to their publicity
materials, and I, the Substitute Chairman, determine its publication:
Article 1. All smoking tobacco-derived products, shall display
on their packaging and in all the associated publicity, a warning
to consumers about the harmful effects that can result from
the use of these products.
Paragraph 1 - Packaging shall be understood to mean packs,
whether soft or cardboard, packets, tins, boxes and any other
packing device used to present the products to the final consumer.
Paragraph 2 - Publicity shall be understood to mean, posters,
advertising panels and signs posted inside sales areas.
Article 2. For smoking tobacco-derived products, the warnings
below shall be displayed simultaneously or sequentially, and
in the last case they shall be changed every five months at
most. The warnings shall be legible, prominently displayed and
include images, always preceded by the words "O Ministério
da Saúde Adverte” [The Ministry of Health Warns]:
The packaging
Article 3. Concerning the packaging of cigarettes, in what
are normally called “packs” or “box”
in their different sizes, the new standard images provided in
the ANVISA website, including warnings, images, logo and Stop
Smoking Dial Number, must be printed on the part of the packaging
most easily visible to the consumer, without changing the proportion
among the elements nor the graphics parameters.
Paragraph 1 - Concerning any type of packaging of tobacco-derived
smoking products that is the same size as those referred to
in the caput of this Article, the standard images, shall be
printed on the side most easily visible to the consumer, without
changing the proportion among the elements nor the graphics
parameters.
Paragraph 2 - Concerning any type of packaging of tobacco-derived
smoking products that is smaller than those referred to in the
caput of this Article, the standard images, shall be printed
on the side most easily visible to the consumer and it is the
responsibility of the manufacturing company or importer of the
product to proportionally reduce the standard image, without
changing its graphic characteristics so that it fits in the
front of the packaging.
Paragraph 3 - Concerning other packaging of tobacco-derived
smoking products that are larger than those referred to in the
caput of this Article, the standard images, shall be printed
on the lower right of the part most easily visible to the consumer,
without changing the proportion among the elements and keeping
its size.
Paragraph 4 - The warning included in the standard image made
available by the National Sanitary Surveillance Agency, shall
be printed in white letters in on a 100% black rectangular background.
Companies that do not have access to the traditional polychrome
technique may use dark gray instead of 100% black, according
to the Pantone™ Scale 419 CV or any other composition
which reproduces the black color, in order to preserve the visual
warning characteristics.
Article 4. The use of any other type of wrapping or device
that makes the visualization of the standard image impossible
or difficult or of resources such as cards or stickers that
may be used by the consumer to cover the image on the packs
of the products mentioned in this Resolution is hereby forbidden.
Sole paragraph. The control stamp of the Federal Revenue Agency
shall not be placed over the standard image, nor may there be
a reduction or change of the graphics parameters of the standard
images to adapt the stamp to the largest side.
Article 5. The printing of the standard image on the pack may
be replaced by a sticker whenever the pack is made of a material
which does not allow or hinders its printing.
Paragraph 1 - The sticker shall comply with the standard image
made available by the National Sanitary Surveillance Agency
maintaining the graphic characteristics and shall not be applied
to the external part of the packaging.
Paragraph 2 - The provisions in this Article apply to imported
cigarettes and to all other smoking tobacco-derived products.
Paragraph 3 - The provisions in this Article do not apply to
cigarettes manufactured or packaged in Brazil.
Article 6. Article 3 of Resolution RDC nº 46 dated 28
March 2001 of the Collegiate Board of Directors shall enter
into force with the following changes:
“Article 3. The printing of the levels of tar, nicotine
and carbon monoxide on the mainstream on cigarette packs shall
be optional.
Paragraph 1 - The text referred to in the caput of this Article
shall indicate in full length and legible type the levels, expressed
in milligrams per cigarette, up to one decimal place for nicotine,
and in whole numbers for tar and carbon monoxide anywhere on
the pack save for the area reserved for the warning information
on the side or for the standard image
Paragraph 2 - Packaging shall be understood to mean packs,
whether soft or cardboard, packets and any other packing device
for products destined for the final consumer market.
Paragraph 3 - (Revoked).
Paragraph 4 - (Revoked).
Article 7. The printing on the packs of the levels of tar,
nicotine and carbon monoxide present in the mainstream smoke
is optional, as long as it is displayed in an area other than
that reserved for the additional phrase mentioned in the caput
of Article 5 or for the standard image, and complies with the
following requirements:
I – They shall be expressed in milligrams per cigarette,
up to one decimal place for nicotine and in whole numbers for
tar and carbon monoxide;
II – They shall be printed in standard Arial font, body
7, in a color that contrasts with the background;
III – None of the levels may be printed on the pack in
isolation, i.e., without the levels of the other substances;
IV – They shall not be used in association to the brand
name of the product, or as a way to identify the brand, thus
creating a false impression that one brand is less harmful to
health than another.
V – They shall not be used for the promotion of the product,
leading to erroneous conclusions as to their characteristics,
composition and risk to health.
Article 8. The following phrase shall be printed along ¾
of the length of cigarette packs, and occupying the width of
the whole of one of the sides of the pack, using white letters
on a 100% black rectangular background:
" Este produto contem mais de 4.700 substâncias
tóxicas, e nicotina causa dependência física
ou psíquica. Não existem níveis seguros
para consume destas substâncias.” [This product
contains more than 4,700 toxic substances and nicotine which
causes physical or psychic dependence. No safe levels exist
for the consumption of these substances].
Paragraph 1 - Companies that do not have access to the traditional
polychrome technique may use dark gray instead of 100% black,
according to the Pantone™ Scale 419 CV or any other composition
which reproduces the black color, in order to preserve the visual
warning characteristics.
Paragraph 2 - Besides the additional phrase that constitutes
a sanitary warning, no other information may be printed in the
area mentioned in the caput of this Article.
Article 9. The following phrase shall be printed along ¼
of the length of one of the sides of all tobacco-derived smoking
products in a contrasting and easily legible type: “Venda
proibida a menores de 18 anos – Lei 8069/1990 e Lei 10.702/2003”
[Sale forbidden to minors under 18 – Law 8069/1990 and
Law 10702/2003]; the use of phrases such as “somente para
adultos” [for adults only], “produto para maiores
de 18 anos”[product for people over 18 years of age] is
forbidden.
Sole paragraph. Save for cigarettes, another side that is visible
to the consumer may be used in tobacco-derived smoking products
in order to better adapt the printing.
The publicity
Article 10. The commercial publicity of tobacco-derived products
that takes place through posters, panels and signs displayed
in the interior of sales points shall contain the standard image
made available at the ANVISA website. This shall be printed
without any change to its graphic characteristics, and shall
occupy an area of 10% of the total publicity material in order
to ensure its visibility.
Paragraph 1 - The following additional phrase shall be included
in the publicity mentioned in the caput of this Article: “This
product contains more than 4,700 toxic substances and nicotine
which causes physical or psychic dependence. No safe levels
exist for the use of these substances.” using white letters
printed on a black rectangular background, with an internal
white strip as a frame, using Arial Bold font, complying with
the following minimum dimensions:
0 to 250cm2, body 20
251 to 500 cm2, body 24
501 to 1000 cm2, body 26
1001 to 1500 cm2, body 30
1501 to 2000 cm2, body 36
2001 to 3000 cm2, body 40
3001 to 4000 cm2, body 48
4001 to 5000 cm2, body 52
Paragraph 2 - The printing of the levels of tar, nicotine and
carbon monoxide on the advertising materials of cigarettes is
optional, but when used shall comply with the following requirements:
I - They shall be expressed in milligrams per cigarette, up
to one decimal place for nicotine, and in whole numbers for
tar and carbon monoxide;
II – None of the levels may be printed on the pack in
isolation, i.e., without the levels of other substances;
III– They shall not be used in association to the brand
name of the product, or as a way to identify a brand, thus creating
a false impression that one brand is less harmful to health
than another.
IV – They shall not be used for the promotion of the
product, leading to erroneous conclusions as to their characteristics,
composition and risk to health.
Deadlines for Compliance
Article 11. A period of 9 months counting from the publication
date of this Resolution is hereby established for the manufacturing
companies and importers to make available to the retail market
packs of tobacco-derived products and publicity materials that
comply with this Resolution. Once this deadline has expired,
only the packs that comply with the present Resolution may be
made available for retail.
Paragraph 1 - Products manufactured or imported prior to the
period established in the caput of this Article and which do
not comply with the provisions of this Resolution, i.e., that
comply with Resolution RDC nº 104 dated 31 May 2001, may
be marketed up to 18 months after the publication of the present
Resolution.
Paragraph 2 - The above-mentioned deadlines shall apply to
every product derived from smoking tobacco, without exception,
including cigars, mini cigars, Bali cigarettes, kretek cigarettes,
and others.
Article 12. Resolution RDC nº 104 dated 31 May 2001 and
RDC nº 14 dated 17 January 2003 and their republications
by the Collegiate Board of Directors are hereby revoked.
Sole paragraph. Notwithstanding the revocation of Resolution
RDC nº 104 dated 31 May 2001, its determinations shall
be complied with when manufacturing packaging and publicity
materials manufactured or imported before the end of the deadline
established in the caput of the previous Article, if the Company
has not yet started to manufacture them according to the new
rules of this resolution.
Article 13. . Failure to comply with the provisions set forth
in this Resolution constitutes a sanitary infraction, rendering
the offenders liable to the penalties established in Law nº
6437 dated 20 August 1977 and other regulations.
Article 14. This Resolution of the Collegiate Board of Directors
enters into force on the date of its publication.
CLAUDIO MAIEROVITCH PESSANHA HENRIQUES
