Global Regulatory Issues for the Cosmetics Industry || Global Cosmetic Regulations? A Long Way To Go...

10

Global Cosmetic Regulations? A Long Way To Go ... Sandra B. Schneider

Dougmar Consultants, LLC, Westhampton, "r: USA

10.1 Introduction

The countries discussed in this chapter are upwardly mobile nations with great potential for growth in the cosmetic and personal care markets. Financial benefits are waiting to be reaped by individuals and companies who will carefully investigate the rules and regulations necessary to achieve their goal. This chapter is not meant to be a step-by-step regulatory approach to the regulations of Australia, Brazil, Canada, India, and Russia. It is written to give the reader an insight and an overall understanding of what is involved in preparing cosmetics and personal care products for sale around the world. Each country has its own set of changing and evolving rules and regulations that must be navigated through and carefully followed. A manufacturer cannot decide to put their products on the market without a lot of effort and careful study. Claim substantiation data, product stability tests, and microbiological tests including correct packaging and formulae must be available; it takes months and sometimes years before products can be sold in foreign countries.

K. Lintner (ed.). Global Regulatory Issues for the Cosmetics Industry Vol. 2. 189-233 0 2009 William Andrew Inc.

189

190 GI,OHAL REGULATORY ISSUES FOR THE COSMETICS INDIIS‘I‘RY, VOL. 2

10.2 Australia

10.2.1 Australia’s Cosmetic and Personal Care Products Markets

Australia’s prosperous economy is ranked third in the United Nations’ 2007 Human Development Index (HDI). Its 2007 cosmetic market was worth over U.S. $657 million with the expectation of about a five percent growth in 2008.

Working women with a high disposable income are major consumers; they wear cosmetics daily due to the importance placed on image and the competition in the workforce. Women prefer color cosmetics that preserve and protect their skin against sun damage rather than just improve their appearance. The aging “baby boomer” generation is a generation of innovation driven purchasers; they want cosmetics with age defying properties, foun- dations that protect the skin against UV rays and reduce the appearance of fine lines, treatment ingredients that help a variety of skin problems, and lip glosses and lipsticks with a plumping effect. Long-lasting lipsticks and convenient color palettes for quick touch-ups are also well received by women who appreciate the convenience of carrying fewer items in their purse.

Other key growth areas are men’s grooming products, baby products, der- matological products, “doctor brands,” and aromatherapy products. The Australian cosmetic consumer is both price conscious and fashion focused; they follow styles set by their favorite movie stars, fashion icons, and limited edition color cosmetic ranges. The trend of “organic cosmetics’’ is rapidly growing in Australia as it is worldwide.

10.2.2 National Industrial Chemicals Notification and Assessment Scheme

The Australian Government has strict regulatory requirements for all cosmetic ingredients used in their country, whether the products are imported or domestic, in order to ensure the safety of the workers handling them, of the environment, and of the consumer. Ingredient safety falls under the National Industrial Chemicals Notification and Assessment Scheme (NIC- NAS), administered by the National Occupational Health and Safety Com- mission. NICNAS issues approvals for the use of cosmetic ingredients including legislation that strictly defines “naturally occurring” as unprocessed chemicals in the natural state or extracted only by manual, mechanical,

10: GLOBAL COSMETIC REGIJLATIONS, SCHNEIDER 191

gravitational means, dissolution in water, or heating to remove uncombined water, without any chemical change.

Cosmetic products must meet the Australian definition of cosmetic under the Industrial Chemicals (Notification and Assessment) Act 1989. Cosmetic means:

(a) 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 odors of the body; or (iv) changing its appearance; or (v) cleansing it; or (vi) (vii) perfuming it; or (viii) protecting it; and

(b) The product must be marketed as a cosmetic taking into account the labeling, packaging, advertising and/or the label statements:

- the product must have full ingredient disclosure in accordance with the Trade Practices (Consumer Product Information Standards) (Cosmetics) Regulations 199 1 ;

- the product may be presented as being explicitly for cosmetic purposes only; and

- the product name would NOT of itself make the product a therapeutic good, unless that name makes a reference to a disease, ailment, defect or injury in persons.

maintaining it in good condition; or

A reform of The Industrial Chemicals (Notification and Assessment) Act 1989 for cosmetics came into effect on September 17, 2007, which introduced new cosmetic standards for six cosmetic product categories (see Table 10.1). Under this act the following goods are exempt from the mandatory information standard:

therapeutic goods within the meaning of the Therapeutic

0 cosmetics/toiletries manufactured in Australia for export; free samples of cosmetic/toiletry products; and

0 testers for cosmetic/toiletry products.

Goods Act 1989;

The NICNAS Cosmetic Guidelines 2007 provide a guide to the new legislative requirements. All new cosmetic ingredients (not on the Australian

Tabl

e 10

.1 I

ndus

tria

l Che

mic

als (

Not

ifica

tion

and

Ass

essm

ent)

Act

198

9, C

osm

etic

s Sta

ndar

d 20

07-S

ched

ule

1 St

anda

rds

Item

Pr

oduc

t C

ateg

ory

Prod

uct T

ype

Stan

dard

s

I. F

ace

and

nail

1.1

Tint

ed b

ases

or f

ound

atio

n (li

quid

s,

1.2

Prod

ucts

int

ende

d fo

r app

licat

ion

past

es o

r pow

ders

) w

ith s

unsc

reen

to th

e lip

s w

ith s

unsc

reen

2. S

kin

care

2.

1 M

oist

uriz

ing

prod

ucts

with

su

nscr

een

for d

erm

al a

pplic

atio

n,

incl

udin

g an

tiwrin

kle,

ant

iagi

ng,

and

skin

whi

teni

ng p

rodu

cts

2.2

Sunb

athi

ng p

rodu

cts

(oils

, cre

ams,

or

gel

s, in

clud

ing

prod

ucts

for

ta

nnin

g w

ithou

t sun

and

afte

r sun

ca

re p

rodu

cts)

with

an

SPF

of a

t le

ast 4

and

not

mor

e th

an 1

5

Bot

h:

a. T

he p

rodu

ct m

ust b

e a

seco

ndar

y su

nscr

een

prod

uct

with

in th

e de

finiti

on o

f se

cond

ary

suns

cree

n pr

oduc

t in

AS/

NZS

260

4: 1

998

b. A

ny p

rote

ctio

n fa

ctor

or e

quiv

alen

t cat

egor

y de

scrip

tion

stat

ed o

n th

e pr

oduc

t’s la

bel m

ust b

e in

acc

orda

nce

with

cla

uses

6.2

and

6.3

ofA

S/N

ZS

2604

: 199

8 A

ll of

the

follo

win

g:

a. T

he p

rodu

ct m

ust b

e a

seco

ndar

y su

nscr

een

prod

uct

with

in th

e de

finiti

on o

f se

cond

ary

suns

cree

n pr

oduc

t in

A

S/N

ZS 2

604:

199

8 (i)

no

t be

pres

ente

d as

hav

ing

a su

n pr

otec

tion

fact

or

of m

ore

than

15;

and

(ii)

not b

e pr

esen

ted

as w

ater

-res

ista

nt; a

nd

(iii)

if it

is n

ot s

tabl

e fo

r at l

east

36

mon

ths,

then

an

expi

ry d

ate

or u

se-b

y da

te o

n its

labe

l; (iv

) a

pack

siz

e no

t lar

ger t

han

300

mL

or 3

00 g

; and

(v

) no

t hav

e a

ther

apeu

tic c

laim

, inc

ludi

ng a

ny

repr

esen

tatio

n ab

out s

kin

canc

er, m

ade

for i

t; an

d

3. S

kinc

are

Ant

ibac

teria

l ski

n pr

oduc

ts

b. A

ny r

epre

sent

atio

ns in

con

nect

ion

with

the

prod

uct

abou

t pre

mat

ure

skin

agi

ng li

nked

to s

un e

xpos

ure m

ay

be m

ade

only

if th

e pr

oduc

t mee

ts th

e pe

rfor

man

ce

requ

irem

ents

for a

bro

ad-s

pect

rum

pro

duct

set

out

in

clau

se 7

.2 o

fAS/

NZ

S 26

04:1

998

c. A

ny p

rote

ctio

n fa

ctor

or e

quiv

alen

t cat

egor

y de

scrip

tion

stat

ed o

n th

e pr

oduc

t’s la

bel m

ust b

e in

acc

orda

nce

with

cla

uses

6.2

and

6.3

of A

S/N

ZS 2

604:

1998

(AS/

N

ZS 2

604:

1998

-Sun

scre

en

Prod

ucts

-Eva

luat

ion

and

clas

sific

atio

n, p

ublis

hed

by S

AI G

loba

l) Th

e pr

oduc

t mus

t: a.

be

pres

ente

d as

bei

ng a

ctiv

e on

ly a

gain

st b

acte

ria; a

nd

b. n

ot b

e pr

esen

ted

as b

eing

: (i)

ac

tive

agai

nst v

iruse

s, fu

ngi o

r, ot

her m

icro

bial

or

gani

sms (

othe

r tha

n ba

cter

ia);

or

(ii)

for u

se in

con

nect

ion

with

dis

ease

, dis

orde

rs, o

r m

edic

al c

ondi

tions

; or

(iii)

activ

e ag

ains

t a n

amed

bac

teriu

m th

at is

kno

wn

to

be a

ssoc

iate

d w

ith a

dis

ease

, dis

orde

r, or

med

ical

co

nditi

on; o

r

or m

ucou

s m

embr

ane,

for c

osm

etic

or a

ny o

ther

pu

rpos

e; o

r (v

) fo

r use

in c

onne

ctio

n w

ith a

ny p

roce

dure

as

soci

ated

with

the

risk

of tr

ansm

issi

on of

dis

ease

fr

om c

onta

ct w

ith b

lood

or o

ther

bod

ily fl

uids

; or

(iv)

for u

se in

con

nect

ion

with

pie

rcin

g of

the

skin

(Con

tinue

d)

Tabl

e 10

.1 I

ndus

tria

l Che

mic

als (

Not

ifica

tion

and

Ass

essm

ent)

Act

198

9, C

osm

etic

s Sta

ndar

d 20

07-S

ched

ule

1 St

anda

rds

(Con

tin ue

d )

Item

Pr

oduc

t Cat

egor

y Pr

oduc

t Typ

e St

anda

rds

(vi)

for u

se b

efor

e ph

ysic

al c

onta

ct w

ith a

per

son

who

is

acce

ssin

g m

edic

al o

r hea

lth s

ervi

ces.

or m

edic

al

or h

ealth

car

e pr

oced

ure;

or

veni

punc

ture

or d

eliv

ery

of a

n in

ject

ion

The

prod

uct m

ust b

e pr

esen

ted

as c

ontro

lling

or

prev

entin

g ac

ne o

nly

thro

ugh

clea

nsin

g, m

oist

uriz

ing,

ex

folia

ting,

or d

ryin

g th

e sk

in

Bot

h:

a. t

he o

nly

bene

fits

clai

med

to re

sult

from

the

use

of th

e

(vii)

for u

se in

con

nect

ion

with

a p

roce

dure

invo

lvin

g

4. S

kin

care

A

ntia

cne

prod

ucts

(in

clud

ing

spot

tre

atm

ents

, cle

anse

rs, f

ace

scru

bs, a

nd

mas

ks)

Prod

ucts

for

car

e of

the

teet

h an

d th

e m

outh

(e.

g., d

entif

rices

, mou

th w

ashe

s,

and

brea

th f

resh

ener

s)

5. O

ral h

ygie

ne

prod

uct m

ust b

e co

nseq

uent

ial o

n im

prov

emen

ts to

ora

l hy

gien

e, i

nclu

ding

for

the

prev

entio

n of

too

th d

ecay

or

the

use

of fl

uorid

e fo

r the

pre

vent

ion

of to

oth

deca

y;

and

b. be

nefit

s in

rel

atio

n to

oth

er d

isea

ses

or a

ilmen

ts, e

.g.,

gum

or o

ther

ora

l dis

ease

or p

erio

dont

al c

ondi

tion,

m

ust n

ot b

e cl

aim

ed to

resu

lt fr

om u

se o

f the

pro

duct

Th

e pr

oduc

t mus

t be

pres

ente

d as

con

trolli

ng o

r pr

even

ting

dand

ruff

onl

y th

roug

h cl

eans

ing,

moi

stur

izin

g,

exfo

liatin

g, o

r dry

ing

the

scal

p

5. H

air c

are

Ant

i-dan

druf

f pr

oduc

ts

10: GLOBAL COSMETIC REGULATIONS, SCHNEIDER 195

Inventory of Chemical Substances (AICS), a listing of all industrial chemicals used in Australia between January 1, 1977, and February 28, 1990) are subject to notification and assessment unless they qualify for an exemption. New industrial chemicals of low regulatory concern may be exempt from notification to NICNAS; most exemption categories require no further action prior to introduction except an annual reporting obligation. Cosmetic chemicals that are never allowed exemptions are:

Preservatives Coloring agents UV filters Chemicals prohibited or restricted for cosmetic use in the United States or the EU

Sometimes information justifying a chemical exemption must be provided to the Director of NICNAS, who reports to the Minister for Health and Aging through the Parliamentary Secretary. Companies and/or individuals who introduce cosmetic ingredients or import cosmetic products into Australia must be registered with NICNAS regardless of the amount of chemicals imported and/or manufactured in a registration year, September 1 to August 31 of the following year. NICNAS registration is not the registration of individual industrial chemicals or actual products. NICNAS registration is actually the registration of a business.

10.2.3 Australian Competition and Consumer Commission

Cosmetics must be labeled in accordance with the Trade Practices (Con- sumer Product Information Standards) (Cosmetics) Regulations 199 1 . The Australian Competition and Consumer Commission (ACCC) publishes a booklet that explains the standards, the responsibilities of suppliers and retailers under it, and the ACCC’s role in enforcing it.

Scientific and technical terms and symbols should not be used on the packaging unless they are accompanied by a clear and accurate statement of their meaning. It is not appropriate to rely on consumers to receive a point- of-sale explanation of what the scientific, technical, or other unfamiliar terms mean.

Ingredient statements using INCI (International Nomenclature for Cos- metic Ingredients) nomenclature are mandatory for cosmetics. Incidental ingredients, which are ingredients that have no technical or functional

1 % GLOBAL REGCJLATORY ISS~JES FOR THE COSMEIICS INDUSTRY, VOL. 2

effect in the product and are present at insignificant levels, including pro- cessing aids are not required to be included in the ingredient declaration.

10.2.3.1 Is It a Cosmetic or Therapeutic Product?

Products are determined to be either “cosmetics” or “therapeutic goods” based on two factors:

Composition of the product (the concentration of a particular ingredient may change the classification of the product) and Proposed use of the product (its classification depends on claims made in package inserts, in advertisements, and product packaging)

Where products are labeled and presented in the marketplace explicitly for cosmetic purposes only, a product name would not make the product a “therapeutic good” unless that name makes a reference to a disease, ailment, or defect of the human body. If a consumer thinks that a product name suggests that the product is likely to be used in, or i n connection with preventing, diagnosing, curing, or alleviating that disease, ailment, or defect, the product will be considered to be a “therapeutic good,” and therefore subject to the Therapeutic Goods Act 1989 of February IS, 199 I , and the Therapeutic Goods Regulations administered by the Therapeutic Goods Administration. The objective provides a national framework of therapeutic goods regulations in Australia that ensures the quality, safety, and efficacy of medicines.

10.2.3.2 Acceptable versus Unacceptable Claims

A claim can be a word, a sentence, a paragraph, or simply an implication. The table below is a small section of the document issued by the National Coordinating Committee on Therapeutic Goods (NCCTG) (http://www. tga.gov.au/docs/html/ncctg.htm), which provides product claims guid- ance in relation to cosmetic/therapeutic products. Therapeutic claims for products cannot be made unless the claims are included in the Australian Register of Therapeutic Goods (ARTG). Column A contains claims that are clearly cosmetic-oriented, while Column C contains claims that are clearly unacceptable for a cosmetic. Column B is transitional, and illus- trates how the choice of terminology influences the acceptability of a claim:


Subject Column A Column B Active Acceptable Unacceptable ingredient wording for a wording for a

cosmetic cosmetic claim unless sufficiently modified to provide a cosmetic imdication

Column C Unacceptable wording for a cosmetic (but not necessarily acceptable for a drug) therapeutic ingredient

Aging, antiwrinkle cream

Deodorant

Cover up (hide) age spots (blemishes, dark pigmented areas)

Feel (look) younger (youthful)

Helps prevent (reduce, slow) the signs (appearance) of aging (age lines, premature aging)

Moisturize aging skin, smoothes wrinkles

helps keep you Absorbent that

dry Antiodorant (deodorant)

Fights bad odor Kills odor causing

Temporarily reduces depth of wrinkles by moisturizing antiaging (antiwrinkle)

Helps keep you dry

Any references to fading age spots (depigmentation, bleaching of the skin)

(prevents, stops, reduces, slows, reverses) aging (wrinkles, premature aging, aging process)

Eliminates

Antiperspirant Controls

moisture (sweat) perspiration

Note: Antiperspirants are therapeutic

bacteria goods Note: The examples in the tables are only a guide and are not to be taken as the final authority. Cosmetic companies should seek expert/legal advice to ensure that their proposed claims are not in breach of the Therapeutic Goods Act 1989 and/or the Trade Prac- tices Act 1974.

A misleading or deceptive cosmetic claim may be brought to the ACCC by a private party, a competitor, or user of the product. High fines for companies and for individuals or court orders to stop the offending action may result.

198 GLOBAL REGULATORY ISSUES FOR I H E COSMETICS INDlISTRY, VOL. 2

10.2.4 Therapeutic Goods Administration

Sun care products (SPF greater than 4) need to be “listed” in Australia. There is no process for submitting labels to the Therapeutic Goods Admin- istration (TGA) for preapproval. The “listing process” is a self-assessable application system in which a signed statutory declaration on behalf of the sponsor (manufacturer/importer) states that the product’s packaging meets the required standards. Even though the labels are not reviewed and approved at the time of the listing application, the TGA does perform an audit of 25% of the applications received. If the labels do not comply, the TGA has the power to cancel the listing, request the products to be recalled, and impose fines on the company. A partial list of requirements is given below:

1. Product Names: As previously stated product names can be taken as a claim; words such as “treatment” cannot be used in names; it implies that the product is a medicine. Also, the name of a product should distinguish itself from other products; each variety must be clearly distinguishable.

2. “Ahsolure ” Statements: The therapeutic goods legislation uses stricter medicine advertising rules than those permitted for cosmetics; many terms that are considered “cosmetic puffery” become unacceptable if the “absolute” statement cannot be proven in a court of law.

3. Dual Claims: For sunscreens which include therapeutic claims that are associated with other ingredients, those other ingredients must be considered as active ingredients and must be declared quantitatively on the label and included in the application as actives.

4. Dosage Form on the Label: A reference to the dosage form must be made on the front panel of the packaging. In the case of a cream product you need to include on the front panel a reference to cream. This can be done as part of the contents statement or include it as a part of the name. Also, creams are usually described in terms of weight rather than volume.

For all primary and secondary packaging a statement of the recommended storage conditions is required; for room temperature, the statement should be “Store below 30°C.” Batch numbers and expiry dates must be prefixed by a suit- able code. The approved artwork should show the placement

5. General Packaging:


of the batch number and expiry date. Tubes usually have these details crimped on the end of the tube. SPF must be in letters no less than 1.5 mm and no less than 25% of the largest letter or numeral. The sponsor’s name and address must appear on the primary and secondary packaging. Directionsfor use must specify the age of the intended users. The recommendation is that sunscreens should not be used on infants six months and under. The directions for use and other information should be consistent on all packaging. Directionsfor use need to be specific about reapplication after exposure to water, sweating, etc. Also, it is recommended that a reapplication time be included. Sunscreen category description such as “High Protection Sunscreen” should be included. Any reference to a “Poison Information Centre” must include an Australian phone number. The AUST L number that signifies low-risk, self-medication products, such as sunscreens over SPF 4, needs to be placed on the principal panel of the packaging.

0 Declaration of ingredients: Active ingredients must be declared quantitatively with the units. When the ingredients are declared in terms of %, it is required to designate whether this % is representative of w/w, v/v, w/v, or v/w, i.e., for a cream the appropriate units would be %w/w. Ingredient statements: “Listed” TGA products are not required to include the full ingredient declaration. The only ingredients that need to be declared are preservatives and some other specific ingredients. If the product contains methyl and propyl paraben as preservatives, the label must have the statement “Contains hydroxybenzoates.” The Australian Approved Name for these two ingredients, methyl hydroxylbenzoate and propyl hydroxylbenzoate, must be used. The names should be consistent whenever they are written. List of approved terminology for ingredient names, for units of measurement, and for dosage forms can be down- loaded from the TGA website: http://www.tga.gov.au.

0 “Drug Facts” Panel: The United States uses the heading “Drug Facts” for OTC products. Although Australia has

200 GLOBAL REGITLATORY ISSrJES FOR THE COSMETICS INDUSTRY. VOL,. 2

no objection to its use, the word “drugs” has a negative connotation in the Australian market. Therapeutic goods are considered medicines.

6. Botanical Ingredients: Botanical ingredients claims need to be reviewed and a decision is required as to whether these “extra” ingredients should be viewed as actives or as “cosmetic” ingredients.

10.2.5 Certified Organic Personal Care Products

Many companies are trying to take advantage of the worldwide consumer support for organic products in the cosmetic and skin care markets. The word “organic” has become the new buzzword, but in most companies this term is just a marketing tool. However, Australian products that have over 95% organic raw materials in their products with no synthetic ingredients (this includes no nature identical products) can be called “Certified Organic.” In Australia, the AQIS (Australian Quarantine Inspection Ser- vice) logo, obtained from an approved organic certification body and displayed on the packaging, ensures that the product has been manufactured totally with natural origin and/or organic ingredients. The ingredients must be certified and they must have the appropriate backup certificates. Every “organic manufacturer” has regular factory audits and their formulae are checked to ensure that every ingredient complies with the Organic Legis- lation, which includes a section titled “Cosmetics and Skincare”; this legislation can be found on the AQIS website. The rules and guidelines explain both what can and cannot be in cosmetic products and what can be claimed on the label. It also stipulates that only natural source preservatives and no fragrance or parfum can be used. This legislation allows no misleading organic product statements, but raises other problems with worldwide certifying bodies that have different standards. A universal standard needs to be set so that all companies operate with the same set of rules. Some Australian certifying companies have reciprocal arrangements with American, Japanese, and European certifying companies so that once certified the product can use the appropriate logo in each market.

10.3 Brazil

Brazil is the largest, most populous, and most industrialized country in South America. It ranks fourth in the global market for cosmetic and toiletry sales.

10: GLOBAL COSMETIC REGULATIONS, SCHNEIDER 20 1

Large cities such as Sao Paolo and Rio de Janeiro create huge market out- lets for cosmetics and personal care products and double-digit growth is predicted for this market over the next five years due to the growing mid- dle class that has increased consumer consumption. The increasing number of women in the Brazilian workforce creates consumers with disposable incomes who want good quality mass-market personal hygiene products at affordable prices. Hair care produces the highest retail sales within the cosmetics and toiletries market. The color cosmetics market is likely to increase by 18% and men’s cosmetic sales by 20% by the year 2010.

Brazil is a member of MERCOSUR, a trade organization formed in I99 I , whose purpose is to allow free trade between member states, with the goal of full South American economic integration. This Trade Bloc, comprised of Argentina, Brazil, Paraguay, and Uruguay, is the largest in South America with each country having its own regional organization that issues and harmonizes standards (see Table 10.2). MERCOSUR is similar to the EU, in that it has different legislative and technical committees that create legislation and standards in selected areas that are voted on and if passed they are to be adopted into national law. Over 600 standards have currently been created and adopted by MERCOSUR. Unfortunately, country ratifi- cation is lagging. Adopted and proposed MERCOSUR standards are listed on its Web site: www.amn.org.br. MERCOSUR’s five associate members, Chile, Bolivia, Colombia, Ecuador, and Peru, do not have full voting rights or complete access to markets as MERCOSUR’s full members.

MERCOSUR’s common external tariff (CET) may be imposed by each MERCOSUR member on products imported from outside the region that transits at least one MERCOSUR member before reaching their final des- tination. Full CET product coverage, which would result in duty free movement within MERCOSUR, was originally scheduled for implemen- tation in 2006, but has been deferred until 2009. Brazil’s addition of federal and state taxes and charges to imports can double the actual cost of each imported product imported into Brazil.

Ingredients used in cosmetics are regulated by the lists of prohibited and restricted substances and positive lists of color additives, UV filters, and preservatives, modeled after the Annexes of the EU Cosmetics Directive. On March 17, 2006, Brazil updated its positive list, UV filters, and its negative list, substances that may not be used in cosmetics. The list of UV filters resembles the EU list, but with some UV filters approved in the United States and not in the EU. The negative list contains 423 substances

Tabl

e 10

.2 C

osm

etic

Leg

isla

tion

in M

ER

CO

SUR

Cou

ntri

es (F

ull M

embe

rs)

Arg

entin

a B

razi

l Pa

ragu

ay

Uru

guay

V

enez

uela

Legi

slat

ion

Res

olut

ion

Num

ber

25/0

5 fo

r Cos

met

ics.

Pers

onal

Hyg

iene

Pr

oduc

ts a

nd

Perf

umes

.

Reg

ulat

ory

AN

MA

T, a

gro

up

enfo

rcem

ent

with

in th

e M

inis

try

of H

ealth

. is

the

com

pete

nt a

utho

rity

resp

onsi

ble

for

gran

ting

cosm

etic

ap

prov

al.

Cos

met

ic

Sam

e as

EU

Dire

ctiv

e.

defin

ition

Res

olut

ion

RD

C N

o.

79, f

or C

osm

etic

s. Pe

rson

al H

ygie

ne

Prod

ucts

and

Per

fum

es.

Hea

lth C

ode.

Arti

cle

280.

Law

No.

1 1

19/9

7. D

ecre

e 17

057.

Dec

ree

9973

.

The

Gen

eral

Off

ice o

f C

osm

etic

s with

in th

e B

razi

lian

Min

istry

of

Hea

lth is

the

com

pete

nt

auth

ority

for c

osm

etic

s. Pr

oduc

t reg

istra

tion

and

surv

eilla

nce i

s car

ried

out b

y A

NV

ISA

a p

ublic

co

mpa

ny th

at o

pera

tes

unde

r con

tract

to th

e M

inis

try of

Hea

lth.

Sam

e as

EU

Dire

ctiv

e.

Cos

rnet

ic pr

oduc

ts:

Four

cat

egor

ies

and

two

risk

grou

ps, b

ut s

imila

r re

gula

tions

app

ly to

ea

ch. H

owev

er, f

or

Cat

egor

y 2

The

com

pete

nt

auth

ority

resp

onsi

ble

for c

osm

etic

s is

the

Para

guay

an M

inis

try

of H

ealth

.

Sam

e as

EU

D

irect

ive.

Cos

tnet

ic

spec

ialit

ies:

C

osm

etic

s th

at

mak

e th

erap

eutic

/ pr

even

tativ

e cl

aim

s.

Uru

guay

an L

aw N

o.

15.4

43.

15.7

03. D

ecre

e 25

2987

and

Dec

ree

95/9

0 R

esol

utio

n 19

/05.

The

Che

mic

al a

nd

Phar

mac

eutic

al D

ivis

ion

for C

osm

etic

s of

the

Min

istry

of P

ublic

H

ealth

is th

e co

mpe

tent

au

thor

ity r

espo

nsib

le f

or

cosm

etic

s.

The

“Gui

de f

or

the

Reg

istra

tion

of

Cos

met

ic in

Ven

ezue

la.

6th

Editi

on 2

000”

co

mpi

les

all t

he

nece

ssar

y re

gula

tions

an

d in

gred

ient

list

s.

The

Dru

g an

d C

osm

etic

D

irect

orat

e un

der

the

Gen

eral

San

itary

C

ontro

l Dire

ctor

ate

of

the

Min

istry

of H

ealth

an

d So

cial

Wel

fare

is

the

com

pete

nt a

utho

rity

for c

osm

etic

s.

Sam

e as

EU

Dire

ctiv

e.

Prod

ucts

man

ufac

ture

d fr

om n

atur

al o

r syn

thet

ic

subs

tanc

es to

be

used

on

the

surf

ace

of th

e hu

man

bo

dy: s

kin,

hai

r, lip

s,

nails

, ext

erna

l gen

itals

. te

eth,

and

Prem

arke

t .e

quire

men

ts

Com

pani

es th

at

man

ufac

ture

, im

port,

or

sel

l cos

met

ics

mus

t be

auth

oriz

ed

by A

NM

AT.

Pro

duct

s co

mpl

iant

with

A

NM

AT

regu

latio

ns

rece

ive

auto

mat

ic

appr

oval

and

re

gist

ratio

n.

prod

ucts

eff

icac

y da

ta

are

requ

ired

to s

uppo

rt cl

aim

s m

ade.

Cos

met

ic

man

ufac

turin

g es

tabl

ishm

ents

mus

t re

gist

er w

ith A

NV

ISA

. Lo

cal i

mpo

rters

, m

anuf

actu

rers

, and

di

strib

utor

s m

ust f

ollo

w

spec

ific r

equi

rem

ents

. C

ateg

ory

1 pro

duct

s re

quire

not

ifica

tion:

C

ateg

ory

2 pr

oduc

ts

requ

ire re

gist

ratio

n.

Esta

blis

hmen

ts

that

man

ufac

ture

, di

strib

ute,

or s

tore

co

smet

ics

mus

t be

regi

ster

ed w

ith th

e M

inis

try o

f Hea

lth.

Reg

istra

tion

of a

ll co

smet

ic p

rodu

cts

is

also

requ

ired.

Esta

blis

hmen

ts th

at

man

ufac

ture

, dis

tribu

te,

or st

ore

cosm

etic

s m

ust b

e lic

ense

d an

d re

gist

ered

with

the

Min

istry

of P

ublic

H

ealth

. All

cosm

etic

pr

oduc

ts m

ust b

e re

gist

ered

. Uru

guay

has

no

list

s of

app

rove

d,

proh

ibite

d, o

r res

trict

ed

ingr

edie

nts;

gen

eral

ly

ingr

edie

nts

perm

itted

in

the

Uni

ted

Stat

es, E

U,

and

Japa

n ar

e ac

cept

ed.

oral

muc

osa

in o

rder

to

clea

n, p

erfu

me,

mod

ify

appe

aran

ce, p

rote

ct.

or k

eep

them

in g

ood

cond

ition

and

to p

reve

nt

and

corr

ect b

ody

odor

s.

Esta

blis

hmen

ts th

at

man

ufac

ture

, dis

tribu

te,

or st

ore

cosm

etic

s m

ust

be re

gist

ered

with

the

Min

istry

of

Hea

lth

and

Soci

al W

elfa

re.

All

man

ufac

ture

rs,

dist

ribut

ors,

and

impo

rters

mus

t reg

iste

r w

ith th

e M

erca

ntile

R

egis

try. I

mpo

rters

/ lic

ense

es m

ust h

ave

a po

wer

of a

ttorn

ey/

auth

oriz

atio

n of

di

strib

utor

ship

from

the

fore

ign

bran

d. (C

ontin

ued )

Tabl

e 10

.2 C

osm

etic

Leg

isla

tion

in M

ER

CO

SUR

Cou

ntri

es (F

ull M

embe

rs) (

Con

tinu

ed)

Arg

entin

a B

razi

l Pa

ragu

ay

Uru

guay

V

enez

uela

Labe

ling

rest

ing

and

safe

ty

INC

I ing

redi

ent l

istin

g re

quire

d. L

abel

ing

requ

ired.

Exp

iratio

n re

quire

men

ts a

re

date

s ar

e ne

cess

ary.

lis

ted

by A

NM

AT

Dis

posi

tion

3741

2006

. Pe

rson

al H

ygie

ne

Prod

ucts

. Cos

met

ics

and

Frag

ranc

es d

ated

Ja

nuar

y 23

, 200

6.

INC

I ing

redi

ent l

istin

g

Cos

met

ic

man

ufac

ture

rs

resp

onsi

ble

for

prod

uct's

saf

ety.

GM

P gu

idan

ce in

AN

MA

T 11

0719

9 fo

llow

s the

G

MP

guid

elin

es o

f M

erco

sur R

esol

utio

n 66

/96.

Saf

ety

Test

s in

AN

MA

T 11

0819

9. D

ata

from

cou

ntry

of o

rigin

is

acc

epte

d fo

r im

ports

.

Cos

met

ic c

ompa

nies

ar

e re

spon

sibl

e fo

r th

eir p

rodu

ct's

safe

ty.

Dat

a pr

ovin

g th

eir

safe

ty a

nd e

ffic

acy

unde

r Res

olut

ion

79/0

0 m

ust b

e re

tain

ed.

GM

P gu

idan

ce is

in

Dire

ctiv

e 34

8197

whi

ch

follo

ws t

he M

erco

sur

Res

olut

ion

6619

6

INC

I ing

redi

ent

listin

g is

acce

pted

. C

olor

inde

x nu

mbe

r m

ust b

e us

ed. R

TM 3

6/04

. M

erco

sur R

esol

utio

n G

MC

l361

99 b

y de

cree

10 I

16/

00

univ

ersa

l bar

cod

es

are

requ

ired.

GM

Ps a

re re

gula

ted

by G

MC

lRes

/92/

94

and

GM

ClR

esl6

6/96

fo

llow

ing

the

WH

O

GM

Ps. C

osm

etic

sp

ecia

litie

s: C

ofA

by

aut

horiz

ed lo

cal

labo

rato

ry u

sing

sa

me

lot a

s sa

mpl

es.

No

requ

irem

ents

. IN

CI i

ngre

dien

t lis

ting

is a

ccep

ted.

Spa

nish

la

ngua

ge is

man

dato

ry.

a. N

ame o

f man

ufac

ture

r

b. C

ount

ry o

f orig

in

c. W

eigh

t or v

olum

e de

clar

atio

n.

d. A

nyw

amin

gs;

dire

ctio

ns.

e. L

otha

tch

num

ber

f. O

blig

ator

y he

alth

or di

strib

utor

.

notif

icat

ion

num

ber.

Har

mon

ized

Sp

ecifi

c w

arni

ngs

are

MER

CO

SUR

regu

la-

pres

crib

ed d

epen

ding

tio

n (R

esol

utio

n 66

/96)

on

the

prod

uct.

Eye

and

for G

MPs

. sk

in ir

ritat

ion

data

is

requ

ired.

Cla

ims

need

to

be

subs

tant

iate

d. A

ll pr

oduc

ts a

re a

naly

zed

to c

ount

ry's

stan

dard

s es

tabl

ishe

d by

the

Nat

iona

l Ins

titut

e of

H

ygie

ne.


and closely follows the EU list without the category 1 and 2 CMR substances. In addition, the maximum concentrations for certain preservatives may be the same as in the United States, which is higher than is allowed in the EU.

10.3.1 Product Classifications

Cosmetics, personal hygiene products, and perfumes are classified according to the health risk they may present. Cosmetic products fall into one of the two grades.

Grade I Products: Cosmetic with “no risks” or “risk 1” products with minimal risk, such as soaps, shampoos, shaving creams, aftershave lotions, toothbrushes, dental floss, powders, beauty creams, beauty lotions, oils, makeup, lipstick, lip pencils and liners, eye products, and perfumes. These products no longer need registration, and do not incur administrative fees. However, the Agency must be notified by the cosmetic company using the appropriate form; the product can only be launched on the consumer market 30 days after this notification has been sent.

Grade 2 Products: “Risk 2” products that present potential risk, such as antidandruff shampoos, anticaries and antiplaque toothpastes, feminine deodorants, underarm deodorants, chemical skin peelers, lip protectants with sun protection, certain eye area products, UV filters, tanning agents, hair dyes, bleaches, clarifiers, permanent-wave products, hair growers, depilatories, cuticle removers, chemical nicotine stain removers, nail hard- eners, insect repellents, and products for children. The company must register the product, pay the administrative fees, and wait for the registration approval.

The relevant classification criteria is defined on the basis of product usage purposes, affected body areas, directions for use, and precautions to be taken when using such products. Brazil does not presently have an OTC product category. Thus, sometimes it is very hard to classify an OTC product with the Brazilian legislation.

10.3.2 ANVISA

Brazilian legislation of imported cosmetics products can only be handled by authorized companies registered with AgCncia Nacional de Vigilancia

206 GLOBAL REGULATORY ISSUES FOR THE COSMETICS INDIJSTRY, VOL. 2

Sanitaria (ANVISA), an agency of the Brazilian Ministry of Health. ANVISA was established in 1999 to protect its population by exercising sanitary control over production and marketing products and services. For- eign companies must either establish a local manufacturing unit, a local office, or appoint the “right” Brazilian distributor to hold the registration with ANVISA in order to distribute their products in Brazil. The selection of the right distributor is essential. The contract between a cosmetic company and its distributor should establish specific clauses, which would allow the transfer of ownership of the registration with ANVISA from the local distributor to the manufacturer. In Brazil, this transfer can only occur if the company opens an office or plant in Brazil, since no registration can be transferred overseas. Contracts should contain a clause that deals with the transfer of ownership, a very important clause because without it there is great diffi- culty transferring ownership from one agent to another. Besides selecting a distributor, the foreign company should also apply for registration of the trademark and patent at the National Industrial Property Institute (INPI) through a local law firm, a service usually provided by the distributor.

10.3.2.1 General Labeling Requirements

The Brazilian Customer Protection Code, in effect since September 12, 1990, requires that product labels provide consumers with correct, clear, precise, and easily readable information about the product’s quality, quantity, composition, price, guarantee, shelf life, origin, and risks to the consumer’s health and safety. Imported products should bear a Portuguese translation, and all products should use the official metric units or show a metric equivalent. All cosmetic products must obtain a Global Trade Item Num- ber (GTIN) and Bar Code (EAN Code), which must be printed on the label and submitted to ANVISA as part of the notification process. The product label must also contain the expression: Res. ANVISA no. 3430.5, followed by the Company Operation Authorization Number (N6mero da A u t o r i z q o dr Funcionnmenro de Empresu (AFE)) granted by ANVISA. Product labels must indicate the name and the address of the person responsible for marketing the cosmetic product. Imported products usually have to undergo local over-labeling to comply with these Brazilian regulatory requirements.

10.3.2.2 Advertising/Claims

Brazil’s regulations prohibit therapeutic claims and the use of names of places, symbols, figures, or drawings in labels or advertising that are


misleading as to the origin of the product. Certain claims, such as “hypoal- lergenic” or “dermatologist-tested” must be substantiated. The Consumer Protection Code also governs advertising, direct mail, and telemarketing; there is a general prohibition on false or deceptive advertising, including advertising that is deceptive by omission.

10.3.2.3 Warnings

Specific required warnings, which are listed in Brazil’s legislation, are prescribed for aerosols, hair dyes, bleaches, permanent-wave products, neu- tralizers, depilatories, toothpastes, and mouthwashes, tanning preparations, antiperspirants, and baby products. Sunscreens also have listed their specific required warnings.

Brazilian registration is an online Electronic Notification System for Cos- metic Products that are determined to be Risk Grade 1 Products. Registra- tion can only be completed in Portuguese and the Web site is www.anvisa. gov.br. Since March 1, 2007, ANVISA reviews the Web site information and occasionally asks for the Technical Dossier.

10.3.2.4 ANVISA Product Notification Requirements, May 2007

1. The Negative List: If substances are used from the restric- tive list for products, a report or the specifications of the raw materials and/or of the final product, proving compliance with the required specifications must be submitted and properly signed. If any of the requirements are not met, the file will be rejected.

2. Positive Lists of Substances: Substances used as preservatives, coloring agents, and sun-block filters in personal hygiene products, cosmetics, and perfumes must be positively listed, and must comply with all established param- eters. Lack of compliance with the requirements of these regulations will result in the rejection of the file.

3. Quantitative Formula: If a quantitative listing of the formula is not included, the file will be rejected.

4. Nomenclature-INCZ: All raw materials in the cosmetic product must be identified using the INCI declaration in both the technical data of the product and the ingredient statement that appears on the label. If the INCI nomenclature is not used, the file will be rejected.

208 GLOBAL REGULATORY ISSLJES FOR THE COSMETICS INDUSTRY. VOl,. 2

5. Error in the Declaration qf a Function: The file will be rejected if any substance’s function is incorrectly described in its technical data. This procedure is applied to those substances with functions regulated in the lists of preservatives, coloring agents, and sun-block filters, as well as to those substances that do not have those functions, but which are attributed to them.

6. Physical and Chemical Specijications of the Substances: The range of specifications of the substances or the mini- mum and maximum limits established by the company for substances that have the maximum concentrations established in the legislation cannot surpass the maximum allowed limit. In the case of a specification that exceeds the maximum limit established in the legislation, the file will be rejected.

7. Stability of the Product: Stability studies performed on this product must take into account the storage conditions of samples, the period of time that the product was subjected to tests, and the results determined from those tests. The absence of a conclusion guaranteeing the period of validity declared on the application form will result in the rejection of the file for lack of compliance.

8. Microbiological Data: Microbiological data in accordance with Brazil’s cosmetic regulations must be submitted; incomplete data will result in the rejection of the file. If the cosmetic product is not susceptible to contamination, the company must send its technical justification to prove that there is no such contamination. If such justification is not sent with the application, the file will be rejected.

9. Certtficate qf Free Sale: All imported cosmetic products must have a Certificate of Free Sale, authenticated by the consular office in the country of origin.

10. Formula of the lmported Product: The formula declared in the technical data must be in agreement with the formula of the imported product. In case of disagreement, the file shall be rejected.

I I . Labeling: All claims stated on the label must be proven by corresponding safety or efficacy tests performed on the fin- ished product. Tests performed only on the active ingredients will not be accepted. Labels containing seals from institutions or recommendations from professionals will


only be approved after verifying the contents from the sources. Without verification, the label will be approved with corrections, indicating the exclusion of the allegations.

12. Tests: The efficacy and safety tests, submitted in the registration package or of changes in the registration, must refer to the same product as on the registration application form by name or by code. The test shall be accompanied by the tested formulation and by the declaration signed by the person responsible for this test, indicating that the code or the new name declared in the test refers to the same product. The submitted tests shall contain the test methodology, the results, and the conclusion and be signed by the person with responsibility for such tests. Imported products must include a copy of the original tests signed by the person responsible for such tests; the translation of the results must be signed by the responsible technician and by the company’s legal representative.

13. Similarity: “The Guide for the Evaluation of the Safety of Cosmetic Products” assures that these products are safe based on the safety of similar products. Companies that submit efficacy evaluations based on similar products and safety evaluations outside the considerations established in the Guide shall present a “declaration of the reasons” signed by the person responsible for the tests, It should be clarified that the differences between the tested formulas do not affect the performance nor results of the product nor results of the test, considering the methodology used, the purpose of the product, the tested formulation, and the specific test, to prove the product’s similarity.

14. Absence of Tests Established in the Legislation: Specific tests proving the safety of the product must be presented in the file or in the act to change the registration if they have not been submitted before. The absence of these tests will result in the rejection of the file. For sunscreen products the UVA protection tests, the water resistance tests, and the FPS (Facteur de Protection Solaire) tests must also be submitted with the registration application when benefits are attributed to the product. If the FPS test results are not included in the registration package, it will be rejected. The water resistance and UVA protection test results will allow their claims to appear on the label. Test results from an

2 10 GLOBAL REGULATORY ISSUES FOR THE COSMETICS INDUSTRY. VOL. 2

accredited U.S. laboratory are accepted if it is a member of the mutual recognition arrangement (MRA) of the Interna- tional Laboratory Accreditation Cooperation (ILAC)

IS. Unsigned Documentation: Submitted documents must be signed by the legal representative and the technical responsible individual or the file will be rejected.

16. Final Art: Properly identified final product art must be submitted for approval before the registration package will be passed. The absence of this art will result in the rejection of the file.

17. Absence ofDocuments: Any missing documents will result in the rejection of the file.

A product registration is valid for five years and can be renewed continuously for another five years. Although this process might be costly and time consuming, registering your products will guarantee several benefits including support by law and compliance with the Brazilian Health regulations, product reliability, access to new markets, and the possibility to import and export without sanitary barriers.

Special attention should be paid to the Technical Report that is required by the cosmetics, vitamins, and pharmaceutical manufacturers. The documentation presented for registration, alteration, or revalidation of the registration will be assessed by ANVISA, which will issue its decision through publication in the Federal Government Gazette (Diirio Oficial da U n i b (DOU)).

70.3.2.5 Import Licensing/Customs Valuation

All importers must register with the Secretariat of Foreign Trade (SECEX) to access Brazil’s SISCOMEX computerized trade documentation system whose registration requirements are onerous. Fees are assessed for each import statement submitted through SISCOMEX. Most imports into Brazil are covered by an “automatic import license” regime. Cosmetic companies continue to complain of onerous and burdensome import documentation requirements. ANVISA, which must approve product registrations for imported cosmetics, currently takes about three to six months for the registration process for new versions of existing products, and over six months to register new products. Registration of pharmaceutical products can take over one year, since ANVISA requires that a full battery of clinical testing be performed in Brazil, regardless of whether or not the drug already has FDA approval.

10: GLOBAL COSMETIC REGIJLATIONS, SCHNEIDER 21 1

10.4 Canada

10.4.1 Canadian Cosmetic and Personal Care Market

Estimated cosmetic sales in Canada total over C$5.3 billion annually. Cos- metics sales include both beauty preparations such as makeup, fragrance, nail polish, skin creams, and lotions as well as grooming aids, including soap, shampoo, and deodorant.

Canada has a problem with shampoo and other personal care counterfeit goods that are openly displayed alongside legitimate products in malls, department stores, and chain stores. The problem is compounded by the fact that if counterfeit products clear Canadian Customs, the enforcement efforts are the responsibility of the Royal Canadian Mounted Police (RCMP) and the local police; both groups lack adequate resources and staff.

10.4.2 The Canadian Cosmetic Regulations

Canadian cosmetics are regulated by the Consumer Product Safety Pro- gram of Health Canada, under the Cosmetic Regulations of the Food and Drugs Act, Consumer Packaging and Labeling Act, Hazardous Products Act, and the Quarantine Act. These laws, administered under the Cosmetics Division in the Healthy Environments and Consumer Safety Branch of Health Canada, are intended to prohibit the manufacture of cosmetics and cosmetic-like drugs under non-sanitary conditions or under circumstances that may otherwise cause injury to the health of the consumer. Salons, testers, or professional products have different regulations than those that apply to products sold to the consumer. Advertising Standards Canada (ASC) administers the Guidelines for Cosmetic Advertising and Labeling Claims.

Cosmetics in Canada are defined as any “substance or mixture of substances, manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth and includes deodorants and perfumes.”

On November 16, 2006, amendments to the Cosmetic Regulations came into effect requiring ingredient declarations on the outermost packaging or the unit of sale when no folding carton exists for all cosmetic products sold in Canada. Mandatory labeling allows the consumer and the health care professional to have consistent information to assess and assist in the treatment of individuals who have sensitivities to commonly used ingredients for the purpose of treatment and incidence reporting.

2 12 GLOBAL REGULATORY ISSUES FOR THE COSMETICS INDIJSTRY, VOL. 2

Canada selected INCI from the 10th edition of the Cosmetic Ingredient Dicfionar-y and Handbook published by the former CTFA whose present name is Personal Care Product Council. Canada’s ingredient listings are consistent with the nomenclature used in most countries around the world. Canada maintains:

A dual language requirement that must be honored for all printed packaging except in the INCI ingredient listing; the declaration must not be translated, altered, or embellished except for trivial names. Canadian INCI utilizes trivial names for certain common ingredients under very specific guidelines. European trivial name designations like aqua and cera alba are acceptable in Canada and the EU, but not in the United States. If the company wants a “global” label then the English trivial names, water and beeswax, and the French equivalent, eau and cire d’abeille, must be shown. The Canadian system, which the EU reluctantly accepts, complicates the harmoni- zation process. “Fragrance” and “flavor,” respectively, are the English equiv- alents to the French “parfum” and “aroma.” These statements must be at the end of the ingredient list, after the ingredients in descending order of concentration (by weight) and the ran- dom order of ingredients less than 1 %. Ingredient declarations may use +/- (or) [+ or -1 as refer- enced in the regulation applicable to colorants when used on a product with a color range. Either their INCI name or the color index numbers designation may be used. Any permitted ingredient having no designated INCI name must be listed by its chemical name.

Small packages and ornamental containers are subject to a number of off- pack labeling and hang-tag exemptions, and special situations may allow alternative ingredient labeling options. Testers and samples are exempt from required ingredient listings because it is assumed that they will be located near their corresponding retail products.

The Consumer Puckaging and Lnbelling Act (the “CPLA”) contains packaging and labeling requirements for “prepackaged products.” The CPLA affects not only goods that originate in Canada, but also goods imported into Canada and thereafter sold in prepackaged containers. The CPLA


defines “prepackaged products” as any product that is packaged in a con- tainer in such a manner that it is ordinarily sold to, used, or purchased by the consumer without being re-packaged.

The CPLA requires certain information to appear on the product label: (1) the common or generic name of the product; (2) a declaration of net quantity, generally in numerical count or metric units of measurement (although supplementary non-metric measurements may also be used); and (3) the identity and address of the person by or for whom the product was manufactured, sold, or imported

If the product is imported, then one of three particular formats must be used: (i) the name and address of the Canadian dealer, preceded by the words “imported by” or “imported for”; or (ii) the country of origin adja- cent to the name and address of the Canadian dealer; or (iii) the name and address of the dealer located outside Canada.

All manufacturers must submit a Cosmetic Notification form to the Health Protection Branch for each cosmetic product placed on the market. The ten-day feature allows either a manufacturer or an importer ten days to notify the Canadian authorities following first sale of a cosmetic.

10.4.3 Drug Classifications

Canada has two categories for cosmetic-like drugs: natural health products and therapeutic products. Sunburn protectants and other products considered to be cosmetic-like drugs in Canada (OTC drugs in the United States), are not affected by the new cosmetic regulations. They continue to follow the ingredient labeling specified in the Food and Drug Act or Natural Health Product Regulations. The composition of the product determines its classification:

Natural health products: Products that fall within these regulations include herbal remedies, homeopathic medicines, vitamins, minerals, traditional medicines, probiotics, amino acids, and essential fatty acids. Therapeutic products: All other drug-like cosmetics.

Cosmetics that are classified as non-prescription drugs/OTC are subject to Category IV Monograph requirements and must undergo a premarket approval by the Therapeutic Product Directorate (TPD) or Natural Health

214 GI,ORAI, REGULATORY ISSUES FOR THE COSMETICS INDIISTRY, VOL. 2

Products Directorate prior to sale. Drug establishments must be registered and hold a Drug Establishment License. Mandatory product registration must include certification of compliance with the drug GMPs that the product contains no prohibited substances, and that supportive data is accurate and complete with respect to the applicable monograph. Once properly registered as per the Health Canada guidelines, a non-prescription drug product is issued a Drug Identification Number (DIN). It takes several months to actually receive a DIN or a Natural Product Number (NPN) after notification that your application was received.

List of product category monographs (used by the personal care industry) Acne Therapy October 12,2006 Anti-Dandruff Products October 12,2006 Antiperspirant November 7,2007 Antiseptic Skin Cleansers December I I , 2006 Diaper Rash Products April 19, 2007 Fluoride-Containing Anti-Caries Products August 16,2007 Medicated Skin Care Products March 30,2007 Sun bum Protect ants October 12,2006

In terms of cosmetic ingredient regulation, there is considerable change in the way Health Canada handles raw material safety and environmental impact assessments. For cosmetics, ingredient restrictions are published in several sections of the Cosmetic Regulations, whereas non-prescription drug requirements appear in the Category IV Monographs.

10.4.3.1 Claims

There are prohibitions against making false or misleading statements on product packaging and labeling or in advertising. These prohibitions cover not only the actual words used on labels, or in advertising, but also the general impression conveyed and, accordingly, provide the relevant government body with broad discretion to regulate certain words and symbols. Furthermore, competitors may have a cause of action arising from such statutes. Accordingly, care should be taken ensure that statements are not misleading in any way. Health Canada challenges claims and our industry takes the position that data substantiation supports the claim.

10.4.4 Country of Origin Marking Program

The North American Free Trade Agreement (NAFTA) came into force on January I , 1994, between Canada, Mexico, and the United States. It strives


to promote fair competition, increased investment, to protect and enforce intellectual property rights. This agreement affects many areas of trade.

Pursuant to the “Country of Origin Marking Program,” certain goods imported for sale in Canada must be marked with their country of origin. This program is governed by three sets of Regulations, the Customs Tariff

1. Marking of Imported Goods Regulations; 2. Determination of Country of Origin for the Purpose of

Marking Goods (NAFTA Countries) Regulations; and 3. Determination of Country of Origin for the Purpose of

Marking Goods (Non-NAFTA Countries) Regulations.

These regulations differentiate between “NAFTA goods” vs. “non-NAFTA goods.” Two schedules list the imported goods that must be marked with their country of origin and also schedules listing NAFTA and non-NAFTA goods that are exempted from the regulations.

The Marking of Imported Goods Regulations provide that the country of origin marking on NAFTA goods may be in English, French, or Spanish, whereas on non-NAFTA goods it may be in English or French. The regulations further require the country of origin to be marked in a manner that is legible, sufficiently permanent and capable of being seen easily under nor- mal handling of the goods or their containers. Also, the regulations state that if the words “Canada” or “Canadian” or the name of any country other than the country of origin appears, then the country of origin must appear in close proximity to such words and must be preceded by words such as “made in,” “produced in,” “printed in,” etc., because displaying another country’s name may mislead the consumer into believing that the product has been made in that other country.

The test to determine “country of origin” is different for goods imported from a NAFTA country versus goods imported from a non-NAFTA country. For goods imported from a non-NAFTA country, the country of origin of goods is simply the country in which the goods were “substantially manufactured.” However, since preferential tariff rates are available for certain NAFTA goods, the test to determine country of origin for goods imported from a NAFTA country is much more complex. Accordingly, for goods imported from a NAFTA country, unless the goods are wholly manufactured in a NAFTA country from materials domestically obtained there, the Determination of Country of Origin for the Purpose of Marking Goods (NAFTA Countries) Regulations must be carefully reviewed to determine the country of origin.

10.4.5 Raw Material Information

Canada ’s “Hotlist”: The Cosmetics Division is revising its List of Prohib- ited and Restricted Cosmetic Ingredients, also known as the “Hotlist,” which has grown to nearly 500 ingredients. Despite the large increase of ingredients, most of the materials are not currently found in cosmetics. In early 2008, the Canadian government proposed to place cyclopentasiloxane DS, a silicone, commonly used in personal care, on its toxic list during a comprehensive safety review of chemicals found in consumer goods. This raw material is considered an environmental hazard to water-based organ- isms but it is described as being safe at current levels of exposure for humans. If this chemical is not successfuly defended, it will be added to the federal list of substances that are toxic for the environment or human health.

Under Canada’s Chemicals Management Plan, over 200 substances that have been identified as potentially hazardous are being reviewed by the government before they release its conclusions about the ingredients at regular intervals over the next few years.

A “toxic” chemical may initially only be added to the list, which is the first step in a regulatory process to help the authorities control its use. The next step may be removal from the market. Hopefully this process will be based on science and not politics.

CEPA: On the environmental side, regulations were established in 1994 under the Canadian Environmental Protection Act (CEPA), to require “New Substance Notification” when new chemicals or polymers are manufactured or imported into the country. Appropriate documentation is required in order to make an environmental and human safety assessment for chemicals used i n specified volumes. Chemicals found unacceptable are deemed “CEPA Toxic.”

DSL: Canada has developed a chemical inventory, Domestic Substances List (DSL), of about 23,000 substances. New materials that are regulated under the Food and Drug Act are reported to the DSL, where one of the functions is to determine the potential presence and impact on the environment.

Canada VOC Rqulatioizs: Canada is proposing volatile organic compound (VOC) regulations for the following personal care categories:

I . heavy duty hand cleaner or soap 2. hair mousse


3. hair shine 4. hair spray 5. hair styling product (all forms) 6. nail polish remover 7. personal fragrance product 8. shaving cream 9. shaving gel

10. antiperspirant and deodorant

The proposed rule permits products that exceed the prescribed VOC limits to be sold only for two years following publication of the final rule, which places an unreasonable burden on manufacturers and retailers to police the extremely small number of non-compliant products that may still be in circulation after two years.

Nanotechnology: It has been proposed that nanotechnology be regulated under CEPA. A common definition of nanotechnology applications in our industry needs to be written.

Natural and Organic Cosmetics Industries: Natural and organic manufacturers are upset because it is very difficult to sell genuinely natural or organic-based personal care products due to the lack of industry-wide certification that clearly identifies the fact that they comply with standards. Many brands call themselves natural or organic but in actuality they are not, which leaves consumers confused over what is really true.

10.5 India

10.5.1 The Indian Cosmetic Market

India is considered an emerging market due to its one billion plus population and its lucrative trade opportunities. This country comprises only 2.4% of the world’s land area but has the world’s highest population den- sity with the world’s second largest economy. The Indian retail market over the next five years is estimated to grow 30-50% annually, reaching $45 billion by 2010 (according to a report from the market research company the Kline Group), which makes India one of the fastest growing economies in the world. Trade barriers have been slowly reduced since 1992 when the government lifted the ban in the Foreign-Exchange Regula- tion Act 1973 on reselling by foreign-owned corporations but reform is

2 18 GLOBAL REGIJLATORY ISSlJES FOR T H E COSMETICS INDIJSTRY, VOL. 2

still needed. Key factors necessary for business success in India include finding good partners who have knowledge of the local market and proce- dural issues, strategic planning, follow-up, and protection of intellectual property. India's market requires the analysis and knowledge of consumer preferences, distribution channels, local customs, pricing, labeling, and marketing practices. Personal meetings and relationships with potential agents and due diligence are also extremely important. Multiple agents are often required to serve each state in the country.

A foreign company or an individual planning to set up business operations in India but choosing not to establish a subsidiary or to form a joint venture with an Indian partner can do so by establishing one of the following offices; each type has very specific requirements.

I . Liaison or Representative OfJice: A foreign company has a presence in India but does not directly engage in commer- cial transactions. Its purpose is to oversee their networking efforts, promote awareness of products, and to explore further opportunities for business and investment.

2. Branch Office: An extension of the foreign company that represents the parent company, acts as its buying/selling agent, conducts research for the parent company, carries out import and export trading activities; promotes technical and financial collaborations between Indian and foreign companies, renders professional or consulting services and technical support to the products supplied by the parent/group companies. A branch office is not allowed to manufacture goods directly although it can subcontract this activity to an Indian manufacturer.

3 . Project Office: A temporary project office for the parent company. It is essentially a branch office set up for the limited purpose of executing a specific project. Approval for project offices is generally accorded for executing government-supported construction projects or where the projects are financed by Indian and international financial institutions and multilateral organizations. In exceptional cases, approval is also given for private projects.

The above entities are not permitted to acquire real estate but they are allowed to lease property in India for a maximum period of five years.


10.5.2 Cosmetic Regulations

The Government of India-Ministry of Health and Family Welfare (Department of Health) The Drugs and Cosmetics Act and Rules defines a “cosmetic” as:

any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attrac- tiveness, or altering the appearance, and includes any article intended for use as a component of a cosmetic.”

A “drug” includes:

(i) all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes; (ii) such substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of vermin or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette; (iii) all substances intended for use as components of a drug including empty gelatin capsules; and (iv) such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board;”

The Central Government of India regulates cosmetics by The Drug and Cosmetic Act, 1940, amended on June 30,2005; The Drug and Cosmetic Rules, 1945, amended on June 30,2005. The Bureau of Indian Standards (BIS) has created several standards such as:

1. List of Safe Colors and Dyes 2. List of Substances Generally Not Recognized as Safe

(GNRAS)

The Department of Metrology (Weights and Measures) deals with labeling and Standards of Weights and Measures (Packaged Commodities) Rules.

Ayurvedic, Siddha, and Unani drugs are not dealt with in this chapter.

All Central Government’s rules and regulations are interpreted identically within each Indian State. Taxes levied on cosmetics are dependent upon the state where the store is located and the amount of the state taxes depends upon the number of industries in that state. The lower the taxes, the more industry is attracted to that state.

10.5.2.1 Domestic Cosmetic Regulations

Domestic cosmetic companies presently must register their products in their state at a cost equal to approximately U.S. $4.00, by submitting to its Ministry of Health (MOH) the following documents:

1. Product labels-Hindi, the national language, is most widely spoken but in practice English is the language that mostly appears on cosmetic labels; other languages are optional but labels have very limited space.

2. Quantitative list of ingredients with ranges and BIS numbers.

3 . GMP statement-general manufacturing method. 4. Product specification.

The MOH form allows up to ten product categories to be registered on each form. Registration approval takes two to six weeks and is in effect for five years. No products may be sold by any cosmetic company until the approval is received.

10.5.2.2 Import Cosmetic Regulations

At this time, officially, it is necessary to obtain a “Non-Objections Certifi- cate” (NOC), for each product that a cosmetic company wants to import into India. The NOC is a letter stating that a specific product has been approved by the Central Government and must be in hand before the product can be imported. It is necessary for an Indian importer or an Indian entity to submit the following documents to the MOH when applying for the NOC:

10: GLOBAL COSMETIC REGULATIONS. SCHNEIDER 22 I

1. Product labels 2. Certificate of Free Sale 3. List of ingredients with BIS numbers 4. GMP statement-letter of adherence 5. Quality assurance certificates 6. Manufacturing license-attested by the Indian Consulate in

the country where the manufacturing site is located 7. A declaration of compliance stating that the product con-

tains no banned ingredients and that only safe colors and dyes are used

The NOC is specific to a product name and manufacturer. If any changes are made to the product, the NOC must be amended. There is no charge for a NOC.

It appears that in practice the large corporations have been importing cosmetic products without obtaining a NOC. Indian customs officials (Inspec- tors) usually stop products only if they perceive the product to be a drug and not a cosmetic based on claims, no therapeutic claims are allowed for cosmetics, and ingredients. Some general regulatory information:

1. Antiaging claims for wrinkles are not considered a drug claim.

2. Whitening products are considered cosmetics. 3. Sunscreens have no special regulations. Approved sun fil-

ters and required warnings are listed in the India Standard 4707 (Part 2):2001 Annex D.

Inspectors have the right to take samples from incoming shipments for testing or analysis but must forward a receipt to the cosmetic company acknowledging that samples were removed from the shipment.

The Indian Government has proposed The Drugs and Cosmetics Rules Amendment Notification No. GSR 63(E) dated February 2, 2007, which specifies that imported cosmetic products would be obliged to register, thus replacing the need for the NOC. Cosmetic products that already have a NOC would have to use the new system; no drug or cosmetic products would be allowed to enter the country without an approved registration. There would be no postmarket surveillance for cosmetics.

India signed the WTO (World Trade Organization) Agreement on Techni- cal Barriers to Trade and since this proposed regulation directly affects the

222 GLOBAL REGULATORY ISSUES FOR TIiE COSMETICS INDrJSTRY, VOL. 2

international trade of cosmetics products, the Government of India is obligated to notify the WTO prior to enacting any changes to the Indian Cosmetics Regulations. The Indian Government is promoting this amendment as a method to insure an increase in consumer product safety and to curtail grey goods and counterfeit imports of cosmetics. But, it appears that this amendment only introduces onerous requirements that would affect worldwide trade among countries that want to sell cosmetic products in India especially for the small and medium-sized companies. The cosmetics industry is a continuously evolving industry always creating new products, and most manufacturers and marketers have established standards, systems, and controls that ensure a high level of product quality and safety.

This new system is discriminatory against imported cosmetics in the following aspects. The importer’s registration is valid for three years; the local manufacturer’s certificate is valid for five years. Foreign-owned manufacturing sites receive a five-year certificate. India distinguishes the local certificates as a license to manufacture and the importer’s registration as a license to import. All cosmetics will be treated the same regardless of its product type or risk.

The European Cosmetic Trade Association (COLIPA), the Personal Care Product Council (the United States Cosmetic Trade Association, formerly the CTFA), and India’s Cosmetic Trade Association (ISTMA) hope to maintain a notification process that exists in most of the major markets in the world coupled with postmarket surveillance, rather than a premarket registration. This procedure would allow companies to launch products without additional and costly delays as it is needed for a trendsetting industry. Cosmetics are linked to fashion, which frequently changes and demands quick product launches so that companies can remain competitive in the global marketplace.

As of this book’s print date, the following are India’s proposed regulations:

I . Separate registrations are necessary for each manu-facturing facility. The registration fee is US $250.00.

2. Product registration for a product such as a lipstick, eye shadow, face powders, where only the colorants differ (shaded product); each product type can be registered once as long as the base is the same.

10: GLOBAL COSMETIC REGULATIONS. SCHNEIDER 223

3.

4.

5.

6.

7.

8.

9.

Local manufacturers have licenses that are controlled by each state while an importer’s license is on the federal level. Facility inspections will not be standard practice for manufacturers that have proven to have high quality products. Inspections will be only for non-proven manufacturers. Importer application will have a six month registration period as an end limit. It is hoped that the process will be completed within one to three months. The safety data from accredited foreign laboratories and manufacturers will be accepted in addition to the data from Indian approved laboratories. When approved, this plan goes into effect within six months to one year. Products already imported into India will not be taken off the shelves. The International Nomenclature for Cosmetic Ingredients (INCI) will be accepted for use in the product’s ingredient statement. Application forms will be available online.

10.5.3 Summary

The proposed rules are in question of India’s WTO commitments to provide national treatment to “like products.” Cosmetics are “feel good products” meant for external application and it is unlikely that any bodily harm will result from their usage. Stringent restrictions are necessary for drugs, but if even some of the same rules are applied to cosmetics it might encour- age countries or trade groups to impose restrictions on imports of cosmetics from India. Countries are presently liberalizing world trade and tariff barriers to allow free trade. Sections of India’s present proposal acts as a non-tariff barrier to free trade.

The Government of India has been accepting comments from several cosmetic industry trade organizations and talks are in progress which has resulted in some changes, but there is still disagreement among the partici- pants. At this time the Indian Government is not in favor of a manufacturer accountability system which exists in many countries around the world and is the desired method of dealing with cosmetics. They are determined to put into effect a pre-registration system, which they feel works best for them based on their experience with pharmaceuticals.

224 GLOBAL, REGLJLAI‘ORY ISSLJES FOR THE COSMETICS INDUSTRY, VOL. 2

Indian regulations become law one year from the acceptance date by the government body that wrote the law.

10.6 Russia

10.6.1 The Russian Cosmetic Market

The Russian Federation has had a fast growing cosmetics and personal care market since the mid- 1990s when the first free-standing cosmetic store opened in Moscow. Women would flock to the store forming long lines to look at the products even though most of them could not afford to buy. The Western concept of “looking good” has profoundly impacted the development of the Russian cosmetics and toiletries market. As its economy has prospered, research shows that today more than 90% of Russian women wear lipstick, more than 80% use moisturizing products for skin, 90% use perfumery, and more than 80% of the Russian women use makeup every day. The Euromonitor International also forecasts a 60% overall market growth of Russian cosmetics and toiletries in the next five years.

Today, Russian consumers are more willing and able to purchase luxury goods and their selection of products is not based entirely on price; quality and functionality are a key criterion in their purchasing decisions. Niche and premium products sell well; a trend that is most evident in the skin care area. Skin care sales are expected to achieve a 90% increase since manufacturers introduced the concept of “skin types.” Advertisers encour- age consumers to use a variety of specially designed products in their daily skin care regimen which has resulted in a positive impact on market growth.

Advertising, both traditional and Internet forms, plays a significant role in raising consumer awareness of the range of available cosmetics and knowledge concerning raw ingredients, quality, benefit, and function of a product. The Internet is also a promising outlet for additional sales as more Russian families are buying computers. Meaningful growth is expected in the sun care products sector, influenced by the fact that it is now recommended that people use sun care products all year round. The men’s toiletries and shave products market is wide open and manufacturers see great potential. The above markets present an opportunity for both local and foreign manufacturers to positively impact Russian economic growth. Consequently, foreign companies are beginning to include the Russian market in their strategic planning.


Distribution networks have greatly improved, enabling supermarkets and chained boutiques to expand geographically. Consumers now have access to products outside of the city centers, and the result is higher sales. The improved networks have also helped to reduce the prevalence of counterfeit products that plague the Russian market.

Direct sales greatly impact the cosmetics and toiletries industry, particularly in the skin care and color cosmetics sectors. Well-trained consultants promoting a full range of skin care products, from cleansers and toners to moisturizers and body care, are the key to success. Spa visits are considered by many Russian men and women an essential part of a healthy way of life.

10.6.2 Cosmetic Regulations

The Russian perfumery and cosmetics market offers favorable conditions for launching new products, but receiving the necessary certification for these products can be frustrating. Russia’s import regimes include burdensome certification for cosmetic and personal care products. While some of these requirements address legitimate health and safety concerns, others appear to be unnecessary requirements for imported goods and they unfairly burden importers. Foreign cosmetic companies who want to enter the Russian market should fully understand the requirements for the Cer- tification of Cosmetics. These companies must have a clear understanding of the procedure in order to refrain from paying unnecessary costs and to secure an effective market entry for their products.

The main Certification Body of the Russian Federation is the Gosstandart which accredits “organizations” by awarding them a Corresponding License. These organizations review cosmetic certification requests and no fees are involved. There are Russian companies-mediators-that charge high fees to acquire the required certificates from an “organization.” The mediators charge the exporter for simply passing their company’s information directly to the accredited organization. Mediators also offer “Spe- cial Certificates” that affirm that “your product” is the best in the marketplace. “Special Certificates” are useless, totally meaningless, and definitely a waste of money.

The correct procedure is, first, your products must conform to the Russian standards. Second, a quality certification, GOST R Certification, which

226 GLOBAL REGULATORY ISSUES FOR THE COSMETICS INDIJSTRY, VOL.. 2

demonstrates compliance with basic safety requirements and the quality certification system in the Russian Federation must be applied for and approved. GOST R has the same meaning as the IS0 9000 series of certificates for the Western companies. This certification will provide cosmetic products with fast access to the Russian market. Third, all imported cosmetic products must undergo Safety (Hygienic) Certification. The Hygienic Certificate confirms conformity of products and services to the sanitary norms and strict observance of the established rules in the process of manufacture, storage, transportation and the sale of products, and services. Fourth, some cosmetic products are required to undergo registration in the Ministry of Health rather than Hygienic Certification such as those for children, dyes (except for toner shampoos and balms), and permanent wave, bleaching, and self-tanning products, as well as intimate hygiene and professional cosmetic products. The registration of these products is three times more expensive than a hygienic certification.

List qf perfumery-cosmetic products subject to mandatory certijcation

1. Face and body care products such as creams, emulsions, milks, gels, jellies, lotions, tonics; oils for skin care refresh- ment, cleaning, moisturizing, etc.; masks; shower and bath agents, etc.; soaps; deodorants and other agents against sweating; powders (powdered talc) for body care; depilatories; shaving agents.

2. Hair care products such as washing agents; balms, condi- tioners, lotions, creams, etc.; agents for hair-making and preserving; agents for curling, fixing, unbending; hair colors, shade shampoos, decoloring agents.

3. Decorative cosmetic articles such as lips care agents; makeup for eyes; powders and paints for applying cosmetics; agents for applying cosmetics; nail care and painting.

4. Products for intimate organs such as hygienic packs, pam- pers, separators, napkins, powders, etc., including perfumery agents.

5. Special cosmetic products such as agents for tanning; agents for tanning with absence of the sunshine; photo-protective agents; agents for skin-whitening; tattoo-making agents, etc.

6. Hygienic and perfuming agents such as perfumes, colognes, and fragrant waters, ether oils, etc.

7. Dental and mouth's cavity care agents such as toothpastes, gels; toothbrushes; tooth powders, denture-care powders,


toothbrushes’ bristle-care; chewing gums, breath-care can- dies; denture-care pills, coloring pills for dental plaque revealing; hygienic lipsticks; dental elixirs, washing agents, deodorants for mouth’s cavities.

8 . Skin-protective products such as ointments, creams, pastes, liquids and other washing agents, and some protective cosmetic substances.

Liquid Cosmetics: State Standard of the Russian Federation COST R 5 1578-2000

Liquid cosmetics are:

1. spirit-based liquid perfumes: perfumes, Cologne waters, perfumery, toilet and aromatic waters; perfumery and toilet waters applied as fragrances;

2. lotions, tonic lotions, and tonics: for a hygienic and/or ton- ing action for care of the skin, hair, and nails;

3. hair waving and setting products: for care of the hair; 4. deodorants and antiperspirant deodorants: for a deodorizing,

scenting, and freshening action;

The liquid cosmetic standard establishes the general technical requirements and methods for testing with the exception of liquid cosmetics in aerosol containers with a propellant, hair lacquer and nail polishes, cold waves, and products for coloring the hair and lips.

Liquid cosmetics must be produced in accordance with the requirements of these standards (see Table 10.3). Acceptance and periodic tests are conducted to verify the compliance of liquid cosmetics with the present standards. Ethyl alcohol must be denatured by additives permitted for use in the Russian Federation. Requirements for ethyl alcohol do not apply to imported liquid cosmetic products.

Consumer packages of liquid perfumes containing ethyl alcohol shall bear a printed inscription indicating the volume ratio or strength (relative, % vol.). Liquid perfumes should contain no general toxic properties, nor shall they produce irritating or sensitizing effects on the skin. The maximum capacity of a liquid perfume bottle is 255 cm3. Expiration dates must be established by the manufacturer for each particular liquid cosmetic product.

228 GLOBAL RBG~JLATORY ISSUES FOR THE COSMETICS INDUSTRY. VOL. 2

Table 10.3 Standards for Production of Liquid Cosmetics

Function Characteristics and Standard

Concen- Extra- Scents Per- Toilet Eaude Scented trated Group fumed Water Cologne Water Scents Scents Water

Appearance Transparent liquid Color Fragrance

Characteristic of the color of the product characteristic of the fragrance of the product

Persistence 60 60 so of scent (hrs, at least)

(absence o f turbidity at temperature. "C)

of ethyl alcohol by volume (%lv, at least)"

proportion of fragrances by volume (96. at least)

Transparency +3 +3 +3

Proportion 55.0 70.0 85.0

Total 30.0 15.0 10.0

so

+3

75.0

10.0

40

+3

75.0

4.0

24 -

+5 +5

80.0 20.0

1 .s I .o

*Mandatory for application as of January I . 2002 Note: For products for use on children. the proportion by volume of ethyl alcohol in liquid perfumes shall be no more than 208.

10.6.3 Certifications

In order to sell cosmetics or perfumes in Russia, it is necessary to obtain the following two documents: Hygienic Conclusion and Certificate of Correspondence.

Hygienic Conclusion: Hygienic Conclusions are issued by the Department of Gossanepednadzor of the Ministry of Public Health:


National products-on the basis of the results of the hygienic evaluation of products and the expertise of the official documentation that defines product requirements, requirements for its production and application. Imported products-on the basis of evaluation of the Certifi- cate of Safety of the supplying country, and the results of testing the products, hygienic evaluation of products, and for- malization of the requirements to the processes of its production, stocking, transportation, application, and utilization that guarantee safety for people.

Certijicute of Correspondence: The Gosstandart of the Russian Federation is comprised of several divisions:

1. Central body of Certification of Perfumery and Cosmetic Products and

2. Central body of Certification of Mouth Cavity Hygiene Agents.

The Technical Committee of the Gosstandart develops, controls, and issues all regulatory documents. Certification is conducted by the Special Certi- fication Body that has a corresponding license and is accredited by the Gosstandart. Toxicological and clinical studies are conducted by medical bodies accredited by the Ministry of Public Health of the Russian Federa- tion and microbiological and physico-chemical research work is conducted by test centers accredited by the Gosstandart of the Russian Federation.

On the basis of the results of this research and the identification of consumer characteristics of a product, the Certificate of Correspondence is issued.

The certification application needs to be completed and the following documents should be attached:

contract copy certificate of origin copy company’s registration certificate (of the company that

hygienic conclusion about safety of this product with test

safety certificate from the product’s country of origin product samples

presents a product for certification)

records of four types of safety evaluation

230 GLOBAL REGULATORY ISSUES FOR THE COSMETICS INDUSTRY. VOL. 2

National manufacturers must also submit:

charter of the producer where perfumery-cosmetic production

qualitative formula quantitative formula technological regulations perfumery-cosmetic production license

is mentioned

The manufacturer, importer, or seller of perfumery-cosmetics gives an Accredited Certification Body, an expert, all the necessary documentation and product samples for testing. The expert also checks the “marking” that should correspond to GOST P5 I39 1-99 Perfumery and Cosmetic Prod- ucts, which is the consumer information mandated by the Consumer’s Rights Protection Law. If a product is imported, this information must be translated into Russian. The Certification Body receives the decision on an application. If the Certificate of Correspondence is granted, it is issued for one year; an inspection is done in six months and samples must be presented again for testing. Special control protocols are issued to the company and the Certificate of Correspondence is marked with a special mark if the manufacturing installation has passed certification and has received a hygienic approval. The certificates can be issued for two or three years with an Obligatory Control. After issuing certificates, certification bodies continue to monitor the advertisement of products that have been certified; in case of violations they can revoke the certificate.

Obtaining the above documents requires direct contact between the authorized manufacturer’s representative and experts from the Center of Norm- Setting and Certification and testing centers accredited by the Ministry of Health. The testing centers assign microbiological, physical chemical, toxicological, and clinical laboratory tests that the products undergo before they can obtain certification. The cost of the hygienic and quality certification depends on the scope of the tests.

Either a distributor or a regulatory contact that is authorized by the manufacturer can apply for the certificates; it cannot be done by correspondence. The testing center signs a contract with the authorized manufacturer’s representative to do the certification work and the manufacturer’s representative provides the testing center with its company charter and incorporation documents. The turnaround time for the certificate is about one month. If a company’s application is rejected, the company may file a request for the Gosstandart to review their application.

10: GLOBAL COSMETIC REGULATIONS, SCHNEIDER 23 1

10.6.4 Certification of imported Ingredients for the Beauty Industry

Imports of oils and other ingredients for the cosmetic industry require a hygienic certificate. Russia has a voluntary quality cert$cation, the GOST R Quality Certificate for Cosmetic Ingredients; Russian manufacturers only purchase ingredients that have a GOST R quality certificate. Compa- nies would be advised to obtain this quality certificate when entering the Russian market.

The certification procedure for ingredients is about the same as for final beauty products. The Center of Norm-Setting and Certification recom- mends qualified testing centers to conduct the tests and to review the documents necessary for certification. An authorized representative of the manufacturer signs a contract with a testing center for certification work. The applicant submits the following documents to the testing center: a contract with a Russian partner/distributor for importation of products and a Certificate of Free Sale from the country of origin. The testing center assigns a number of toxicology, microbiology, and physical chemistry and clinical tests that the ingredient must undergo before the above certificates are issued. Again, the certificates cannot be obtained by correspondence and require the personal involvement of the authorized manufacturer’s representative in the procedure.

Though the above procedures seem complicated, it is routine work for a qualified Russian distributor or regulatory company. It is highly recommended for companies to work with qualified partners when trying to obtain product or raw material certification.

10.6.5 Updates: Russian Perfumery-Cosmetic Products

In November 2004, Russia proposed new technical regulations for both cosmetics and toiletry products based on the EU model. The proposal was drafted by Russia’s two industry associations, the Perfumery and Cosmet- ics Association of Russia (PCAR) and the Association of Perfumery, Cosmetics and Household Chemistry Manufacturers (APCoHM), and presented to the State Duma, which in the Russian Federation is the lower house of the Federal Assembly of Russia headquartered in downtown Moscow, for a first hearing in December 2004. The new regulations would allow companies to submit notification papers three days prior to launch. However, companies need to ensure that their infrastructure and quality control are strong, which is costly for the smaller businesses.

2.32 GLOBAL REGULATORY ISSlJES JOR THE COSMETICS INIXJSTRY, VOL. 2

In an attempt to stop the illegal importation of alcohol into Russia under the guise of perfumes, the Russian Federal Law “On State Regulation of Production and Distribution of Ethyl Alcohol, Alcoholic and Alcohol- Containing Products” took effect on July I , 2006. This law had an immedi- ate negative impact on the country’s cosmetic industry. Until the end of 2006 cosmetics and perfumes containing alcohol were called non-food products with alcohol and the excise taxes doubled for products with more than an 80% alcohol. All companies in the alcohol market had to register their product’s movement with the Integrated State Automated Informa- tion System (ISAIS), which forced many distributors to decide not to sell products containing alcohol. Consequently, the industry was in disarray for months due to this system. To placate the cosmetic and perfume industry, in December 2006 the Russian government passed a law that withdrew perfumery from participating in the ISAIS.

On July 1 , 2007, Perfumes and cosmetics makers were worried by the perspective of the lifting of a waiver on the denaturation of imported alcoholic products. If the denaturation requirement is applicable to perfumes and cosmetics, most of the products imported into Russia would become illegal as they comply with different denaturation requirements. The Russian list of permitted denaturants features four items: bitrex, kerosene, benzene, and crotonaldehyde. Apart from bitrex, these substances cannot be used in cosmetics products in the EU. Several countries and the government of the Russia Federation are involved in discussions to try to amend the list of Russian allowable denaturants.

As of June 1, 2008, WTO discussions are continuing with the Russian Federation to eliminate measures or to modify them so that they would be consistent with WTO requirements. Russia is working to bring its technical regulations into conformity with international standards. It appears that Russia still hopes that sometime in the near future it will become part of the WTO.

Bibliography

ANVISA (2000): Resolution RDC No. 79, of August 28, 2000, on Cosmetics, Personal Hygiene Products and Perfumes, Brasflia, Brazil, National Health Administration Agency.

“Canada regulators will require ingredient labeling in cosmetics.” Chemical Mur- ket Reporter 267.2 (January 10, 2005): 7( I ) . Business and Company ASAP, Gale, New York Public Library Research Lib., March 19, 2008.


“Canada regulators will require ingredient labeling in cosmetics.” (Markets plus: cosmetics & personal care). Chemical Market Reporter 267.2 (January 10, 2005): p. 7( 1). Business and Company ASAP.

CTFA (2007): CTFA International Regulatory Resource Manual, 6th Edition, Washington, DC, USA, Cosmetic, Toiletry and Fragrance Association.

“Mercosur sets lab rules.” Soap Perfumery & Cosmetics 78.1 I (November 2005): 3( I ). Business and Company ASAP, Gale, New York Public Library Research Lib., March 19,2008.

“Russia aligns with Europe on technical regulations.” (Russia Report) (Perfum- ery and Cosmetics Association of Russia). Cosmetics International 28.641 (November 5,2004): p. 4( I). Business and Company ASAP.

Special Chem Cosmetics-On-Line Newsletter a. “Natural vs. organic vs. certified organic In Australia,” April 23, 2008, Greg

b. “Global Organic Certification,” February 1,2008, Nick Morante. c. “Cosmetic Regulations in Latin America’s 20 Largest Countries,” March 22,

d. “Cosmetic Regulation in North America-USA & Canada,” October 12,

http://www.beauty-on-line-On-Line Newsletter: “Moscow (Russia) Perfumes

Milham.

2007, Dr. Annelie Struessmann.

2006 Dr. Annelie Struessmann.

and cosmetics exempted from Russian alcohol law,” June 28, 2007.

Helpful Websites

BfR (Federal Institute for Risk Assessment): http://www.bfr.bund.de/cd/

Canadian Department of Justice: http://canada..justice.gc.ca/en/ Canadian Hazardous Products Act: http://laws..justice.gc.ca/en/ShowFullDoc/

Health Canada: http://www. hcsc.gc.ca/cps-spc/person/cosmet/faq-e.html http://www.hc-sc.gc.ca/cps-spc/person/cosmet/info-ind-prof~ot-list-critique/

hotlist-liste eng.php http://www.anvisa.gov.br http://bilaterals.org http://www.cosmeticdesign.com http://www.cosmeticsinrussia.com http://www.nicnas.gov.au http://ww w.osec.ch http://www.tga.gov.au/cosmetics http://www.uktradeinvest.gov.uk

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