Anvisa -


	Portugu=EAs =	Espa=F1ol =20

Resolution - RDC n=BA 335, dated 21 = November=20 2003
Federal = Official=20 Gazette D.O.U. dated of=20 11/24/2003

Revokes RDC n=BA 104 date 31 May = 2001 and RDC=20 n=BA 14 dated 17 January = 2003.

The Collegiate Board of Directors of the National = Sanitary=20 Surveillance Agency, in the use of the attributions vested = in it=20 under Article 11, item IV, of the ANVISA Regulation approved = by=20 Decree n=BA 3.029 dated 16 April 1999 c/w Article 111, item = I, letter=20 =93b=94, =A7 1 of the Internal Regulation approved by = Presidential Decree=20 n=BA 593, dated 25 August 2000, republished on 22 December = 2000, in=20 meeting held on 19 November 2003,

WHEREAS

Law n=BA 9782 dated 26 January 1999, that determines the=20 regulation, monitoring and inspection of products and = services that=20 involve a risk to public health;

Law n=BA 9294 dated 15 July 1996;

Federal Law n=BA 10167 dated 27 December 2000;

Resolution - RDC n=BA 46 dated 28 March 2001;

Provisional Measure n=BA 2134-30 dated 24 May 2001;

Law n=BA 10702 dated 14 July 2003;

the significant increase of tobacco smoking that caused = the loss=20 of at least 3.5 million lives throughout the world in 1998, = with an=20 estimated loss of 10 million lives per year by 2030, 70% of = which in=20 developing countries,

the images that illustrate the warning messages need to = be=20 periodically updated,

has adopted the following Resolution, applicable to all = smoking=20 tobacco-derived products and marketed in the Brazilian = territory,=20 whether produced locally or imported, and to their publicity = materials, and I, the Substitute Chairman, determine its=20 publication:

Article 1. All smoking tobacco-derived products, shall = display on=20 their packaging and in all the associated publicity, a = warning to=20 consumers about the harmful effects that can result from the = use of=20 these products.

Paragraph 1 - Packaging shall be understood to mean = packs,=20 whether soft or cardboard, packets, tins, boxes and any = other=20 packing device used to present the products to the final = consumer.=20

Paragraph 2 - Publicity shall be understood to mean, = posters,=20 advertising panels and signs posted inside sales=20 areas.

Article 2. For smoking tobacco-derived = products, the=20 warnings below shall be displayed simultaneously or = sequentially,=20 and in the last case they shall be changed every five months = at=20 most. The warnings shall be legible, prominently displayed = and=20 include images, always preceded by the words "O Minist=E9rio = da Sa=FAde=20 Adverte=94 [The Ministry of Health Warns]:

1. Esta necrose foi causada pelo = consume do=20 tabaco [This necrosis was caused by tobacco consumption];=20

2. Fumar causa impot=EAncia sexual [Smoking causes = sexual=20 impotence];

3. Crian=E7as que convivem com fumantes = t=EAm mais=20 asma, pneumonia, sinusite e alergia [Children in live in = close=20 contact with smokers have more asthma, pneumonia, = sinusitis and=20 allergy];

4. Ele =E9 uma v=EDtima do tabaco. Fumar = causa=20 doen=E7a vascular e pode levar a amputa=E7=E3o [He is a = victim of=20 tobacco. Smoking causes vascular disease that may lead to=20 amputation]

5. Fumar causa aborto espont=E2neo = [Smoking=20 causes spontaneous abortion];

6. Ao fumar voc=EA = inala=20 ars=EAnico e naftalina, tamb=E9m usados contra ratos e = baratas [When=20 smoking, you inhale arsenic and naphthalene, also used = against=20 rats and cockroaches];

7. Fumar causa c=E2ncer de = laringe=20 [Smoking causes cancer in the larynge];

8. Fumar = causa=20 c=E2ncer de boca e perda dos dentes [Smoking causes mouth = cancer and=20 loss of teeth];

9. Fumar causa c=E2ncer de pulm=E3o = [Smoking=20 causes lung cancer];

10. Em gestantes, fumar = provoca partos=20 prematuros e o nascimento de crian=E7as com peso abaixo do = normal=20 [Smoking during pregnancy causes premature births and the = birth of=20 babies with low birth weight];

The packaging

Article 3. Concerning the packaging of cigarettes, in = what are=20 normally called =93packs=94 or =93box=94 in their different = sizes, the new=20 standard images provided in the ANVISA website, including = warnings,=20 images, logo and Stop Smoking Dial Number, must be printed = on the=20 part of the packaging most easily visible to the consumer, = without=20 changing the proportion among the elements nor the graphics=20 parameters.

Paragraph 1 - Concerning any type of = packaging of=20 tobacco-derived smoking products that is the same size as = those=20 referred to in the caput of this Article, the standard = images, shall=20 be printed on the side most easily visible to the consumer, = without=20 changing the proportion among the elements nor the graphics=20 parameters.

Paragraph 2 - Concerning any type of = packaging of=20 tobacco-derived smoking products that is smaller than those = referred=20 to in the caput of this Article, the standard images, shall = be=20 printed on the side most easily visible to the consumer and = it is=20 the responsibility of the manufacturing company or importer = of the=20 product to proportionally reduce the standard image, without = changing its graphic characteristics so that it fits in the = front of=20 the packaging.

Paragraph 3 - Concerning other = packaging of=20 tobacco-derived smoking products that are larger than those = referred=20 to in the caput of this Article, the standard images, shall = be=20 printed on the lower right of the part most easily visible = to the=20 consumer, without changing the proportion among the elements = and=20 keeping its size.

Paragraph 4 - The warning included = in the=20 standard image made available by the National Sanitary = Surveillance=20 Agency, shall be printed in white letters in on a 100% black = rectangular background. Companies that do not have access to = the=20 traditional polychrome technique may use dark gray instead = of 100%=20 black, according to the Pantone=99 Scale 419 CV or any other = composition which reproduces the black color, in order to = preserve=20 the visual warning characteristics.

Article 4. The use of any other type of wrapping or = device that=20 makes the visualization of the standard image impossible or=20 difficult or of resources such as cards or stickers that may = be used=20 by the consumer to cover the image on the packs of the = products=20 mentioned in this Resolution is hereby forbidden.

Sole paragraph. The control stamp of the Federal Revenue = Agency=20 shall not be placed over the standard image, nor may there = be a=20 reduction or change of the graphics parameters of the = standard=20 images to adapt the stamp to the largest side.

Article 5. The printing of the standard image on the pack = may be=20 replaced by a sticker whenever the pack is made of a = material which=20 does not allow or hinders its printing.

Paragraph 1 - The sticker shall comply with the standard = image=20 made available by the National Sanitary Surveillance Agency=20 maintaining the graphic characteristics and shall not be = applied to=20 the external part of the packaging.

Paragraph 2 - The provisions in this Article apply to = imported=20 cigarettes and to all other smoking tobacco-derived = products.

Paragraph 3 - The provisions in this Article do not apply = to=20 cigarettes manufactured or packaged in Brazil.

Article 6. Article 3 of Resolution RDC n=BA 46 dated 28 = March 2001=20 of the Collegiate Board of Directors shall enter into force = with the=20 following changes:

=93Article 3. The printing of the levels of tar, nicotine = and=20 carbon monoxide on the mainstream on cigarette packs shall = be=20 optional.

Paragraph 1 - The text referred to in the caput of this = Article=20 shall indicate in full length and legible type the levels, = expressed=20 in milligrams per cigarette, up to one decimal place for = nicotine,=20 and in whole numbers for tar and carbon monoxide anywhere on = the=20 pack save for the area reserved for the warning information = on the=20 side or for the standard image

Paragraph 2 - Packaging shall be understood to mean = packs,=20 whether soft or cardboard, packets and any other packing = device for=20 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,=20 nicotine and carbon monoxide present in the mainstream smoke = is=20 optional, as long as it is displayed in an area other than = that=20 reserved for the additional phrase mentioned in the caput of = Article=20 5 or for the standard image, and complies with the following = requirements:

I =96 They shall be expressed in milligrams per = cigarette, up to=20 one decimal place for nicotine and in whole numbers for tar = and=20 carbon monoxide;

II =96 They shall be printed in standard Arial font, body = 7, in a=20 color that contrasts with the background;

III =96 None of the levels may be printed on the pack in = isolation,=20 i.e., without the levels of the other substances;

IV =96 They shall not be used in association to the brand = name of=20 the product, or as a way to identify the brand, thus = creating a=20 false impression that one brand is less harmful to health = than=20 another.

V =96 They shall not be used for the promotion of the = product,=20 leading to erroneous conclusions as to their = characteristics,=20 composition and risk to health.

Article 8. The following phrase shall be printed along = =BE of the=20 length of cigarette packs, and occupying the width of the = whole of=20 one of the sides of the pack, using white letters on a 100% = black=20 rectangular background:

" Este produto contem = mais de=20 4.700 subst=E2ncias t=F3xicas, e nicotina causa = depend=EAncia f=EDsica ou=20 ps=EDquica. N=E3o existem n=EDveis seguros para consume = destas=20 subst=E2ncias.=94 [This product contains more than 4,700 = toxic=20 substances and nicotine which causes physical or psychic = dependence.=20 No safe levels exist for the consumption of these=20 substances].

Paragraph 1 - Companies that do not have access to the=20 traditional polychrome technique may use dark gray instead = of 100%=20 black, according to the Pantone=99 Scale 419 CV or any other = composition which reproduces the black color, in order to = preserve=20 the visual warning characteristics.

Paragraph 2 - Besides the additional phrase that = constitutes a=20 sanitary warning, no other information may be printed in the = area=20 mentioned in the caput of this Article.

Article 9. The following phrase shall be printed along = =BC of the=20 length of one of the sides of all tobacco-derived smoking = products=20 in a contrasting and easily legible type: =93Venda proibida = a menores=20 de 18 anos =96 Lei 8069/1990 e Lei 10.702/2003=94 [Sale = forbidden to=20 minors under 18 =96 Law 8069/1990 and Law 10702/2003]; the = use of=20 phrases such as =93somente para adultos=94 [for adults = only], =93produto=20 para maiores de 18 anos=94[product for people over 18 years = of age] is=20 forbidden.

Sole paragraph. Save for cigarettes, = another side=20 that is visible to the consumer may be used in = tobacco-derived=20 smoking products in order to better adapt the = printing.
The=20 publicity

Article 10. The commercial publicity of=20 tobacco-derived products that takes place through posters, = panels=20 and signs displayed in the interior of sales points shall = contain=20 the standard image made available at the ANVISA website. = This shall=20 be printed without any change to its graphic = characteristics, and=20 shall occupy an area of 10% of the total publicity material = in order=20 to ensure its visibility.

Paragraph 1 - The = following=20 additional phrase shall be included in the publicity = mentioned in=20 the caput of this Article: =93This product contains more = than 4,700=20 toxic substances and nicotine which causes physical or = psychic=20 dependence. No safe levels exist for the use of these = substances.=94=20 using white letters printed on a black rectangular = background, with=20 an internal white strip as a frame, using Arial Bold font, = complying=20 with the following minimum dimensions:

0 to 250cm2, = body=20 20
251 to 500 cm2, body 24
501 to 1000 cm2, body = 26
1001 to=20 1500 cm2, body 30
1501 to 2000 cm2, body 36
2001 to = 3000 cm2,=20 body 40
3001 to 4000 cm2, body 48
4001 to 5000 cm2, = body=20 52

Paragraph 2 - The printing of the levels of tar, nicotine = and=20 carbon monoxide on the advertising materials of cigarettes = is=20 optional, but when used shall comply with the following=20 requirements:
I - They shall be expressed in milligrams = per=20 cigarette, up to one decimal place for nicotine, and in = whole=20 numbers for tar and carbon monoxide;

II =96 None of the levels may be printed on the pack in = isolation,=20 i.e., without the levels of other substances;

III=96 They shall not be used in association to the brand = name of=20 the product, or as a way to identify a brand, thus creating = a false=20 impression that one brand is less harmful to health than = another.=20

IV =96 They shall not be used for the promotion of the = product,=20 leading to erroneous conclusions as to their = characteristics,=20 composition and risk to health.

Deadlines for Compliance

Article 11. A period of 9 months counting from the = publication=20 date of this Resolution is hereby established for the = manufacturing=20 companies and importers to make available to the retail = market packs=20 of tobacco-derived products and publicity materials that = comply with=20 this Resolution. Once this deadline has expired, only the = packs that=20 comply with the present Resolution may be made available for = retail.

Paragraph 1 - Products manufactured or imported prior to = the=20 period established in the caput of this Article and which do = not=20 comply with the provisions of this Resolution, i.e., that = comply=20 with Resolution RDC n=BA 104 dated 31 May 2001, may be = marketed up to=20 18 months after the publication of the present = Resolution.

Paragraph 2 - The above-mentioned deadlines shall apply = to every=20 product derived from smoking tobacco, without exception, = including=20 cigars, mini cigars, Bali cigarettes, kretek cigarettes, and = others.=20

Article 12. Resolution RDC n=BA 104 dated 31 May 2001 and = RDC n=BA 14=20 dated 17 January 2003 and their republications by the = Collegiate=20 Board of Directors are hereby revoked.

Sole paragraph. Notwithstanding the revocation of = Resolution RDC=20 n=BA 104 dated 31 May 2001, its determinations shall be = complied with=20 when manufacturing packaging and publicity materials = manufactured or=20 imported before the end of the deadline established in the = caput of=20 the previous Article, if the Company has not yet started to=20 manufacture them according to the new rules of this = resolution.

Article 13. . Failure to comply with the provisions set = forth in=20 this Resolution constitutes a sanitary infraction, rendering = the=20 offenders liable to the penalties established in Law n=BA = 6437 dated=20 20 August 1977 and other regulations.

Article 14. This Resolution of the Collegiate Board of = Directors=20 enters into force on the date of its publication.

CLAUDIO MAIEROVITCH PESSANHA=20 HENRIQUES