Global Regulatory Update - European Candle Association ASBL ...

Global Regulatory Update:
Regulatory Issues in the Candle Industry
Eileen Hedrick
Corporate Vice President
Regulatory Affairs & Fragrance Safety
Belmay, Inc.
Catherine Herman
Vice President
Regulatory Affairs & Fragrance Safety
Belmay, Inc.
Rob Harrington
Director of Regulatory and Safety
Blyth, Inc.

Canada
Proposed Candle Regulations
• Mandatory safety/warning labeling
• Prohibition of lead wicks
• Prohibition against relighting candles
• May appear in the Canada Gazette I
in fall of 2010 at the earliest
• Comment period
• Phase in stage (likely at least 180
days)

Proposed Warning Text
• WARNING: Never leave burning candles
unattended. Do not place burning candles on or
near anything that can catch fire. Keep burning
candles out of the reach of children.
AVERTISSEMENT :
Ne jamais laisser de bougies allumées
sans
surveillance. Ne pas placer de bougies allumées
sur une chose susceptible de prendre feu ou à
proximité. Garder les bougies allumées
hors de la
portée des enfants.
• “Or equivalent”

Small Candle Warnings
• An exception is provided for small
candles which requires only:
• WARNING: Never leave burning candles
unattended.
AVERTISSEMENT : Ne jamais laisser de
bougies allumées
sans surveillance.

Pictogram Option
• May use either ASTM 2058
pictograms or European Standard EN
15494:2007 pictograms
OR

Additional Proposed Regulations
• Labels or tags must be
• Made of nonflammable material or
• Pass candle fire safety testing (ASTM or
CEN Standard) or
• Must have instructions to remove label
before use
• May be imported unlabeled/mislabeled
if properly labeled prior to sale

Ingredient Labeling U.S./California
• Several proposed regulations are
before the State of California and the
U.S. Congress on mandatory labeling
of consumer products
• Things are still in the negotiation
stage
• Uncertainties in what/how/where
consumer products must be labeled

California
• Labeling bill includes air care
products, cleaners/polishes, car care
products
• Must have an internet site that lists
all substances in each product by a
common name

U.S. Congress
• The labeling bill includes air
fresheners, paints, cleaners,
polishes, laundry, dishwashing, and
adhesive products
• Fill disclosure of all ingredients on
the label

ACME Fragranced Candle
INGREDIENTS:
PARAFFIN, AETATE C-10, C
LINALOOL, METHYL DIHYDROJASMONATE, CINNAMYL
ACETATE, METHYL IONONE GAMMA, TRIETHYL CITRATE, JAVANOL, ETHYL
BENZOATE, METHYL-5-PHENYL
PHENYL-2-HEXEN-2-AL ETHYL PYRAZINE-2, CUMINIC
ALCOHOL, DIPROPYLENE GLYCOL TERPINENOL-4, DECYL ACETATE, SANDAL MYSORE
CORE, ALDEHYDE C11 UNDECYLENIC, MANDARIN OIL, PYRAZINE CYCLOPENTA,
ALPHA-IONONE CITRIC ACID, NERYL ACETATE, ESYL METHYL ETHER PARA, GERANIC
ACID, TRIMETHYL PYRAZINE, SULFUROL, CEDARWOOD OIL TERPENES,
PHENYLETHYL DIMETHYL CARBINOL, METHYL CYCLOPENTENOLONE, ALLYL
HEXANOATE, LABDANUM RESINOIDE, EBANOL, ACETYL PROPIONYL, LIMONENE,
E,
TERPINEOL, ISOEUGENYL ACETATE, LINALYL FORMATE, HEXENAL TRANS-2,
EUGENYL ACETATE, ALDEHYDE C18, CYMENE PARA, CINNAMIC ALD DIMETHYL
ACETAL, BISABOLNE, CTRAL, CASSIA OIL, MALTOL, ACETYL PYRIDINE-2,
FURFURALDEHYDE, 2-, 2 , TOL PROPIONATE, GURJUN BALSAM OIL, TINUVIN 5060,
VANILLIN, CINNAMON LEAF OIL, COUMARIN, LYRAL, ETHYL VANILLIN, CLOVE LEAF
OIL, ANISYL ALDEHYDE, CEDRYL KETONE, PATCHOULI OIL, HELIOTROPIN, BENZYL
BENZOATE, EUGENOL, METHYL CINNAMIC ALDEHYDE ALPHA, NUTMEG OIL,
GERANIOL, BUTYL HYDROXYTOLUENE, LEMON OIL, ORANGE OIL TERPENE, ORANGE O
OIL, LAVANDIN OIL, OCTALACTONE GAMMA, CEDRYL ACETATE, ETHYL MALTOL,
BENZYL ACETATE CLARY SAGE OIL, ETHYL BUTYRATE, EXENOL CIS-3, METHYL
DIANTILIS, JASMONYL, CITRONELLOL, BETA-IONONE, CALYPTOL, PHENYLETHYL
ALCOHOL, GERANYL ACETATE, METHYL SALICYLATE, HEXENOL TRANS-2,
DAMASCOL,4-, , HEXYL FORMATE, ISOEUGENYL METHYL ETHER, TAGETTE OIL,
PEPPER OIL, STYRALYL ACETATE, CARYOPHYLENE DISTILLED, BLUE DYE 1, and A
PARTRIDGE IN A PEAR TREE.

Issues with the Bills
• Are candles air care products?
• List every ingredient? Impurities?
• Use of generic terms (fragrance, colors)
• What is the common name of a
substance?
• Label vs. website disclosure?
• Trade secret protection?
• Sell through provision?
• Stay tuned…..

U.S. Consumer Product Safety
Improvement Act (CPSIA) of 2008
• The U.S. Congress passed sweeping
reforms of consumer product regulations
• Primary focus was children’s s products but
other product categories are effected
• Increases enforcement and recall
authority, requires some product testing
and certifications, substantially increases
penalties and establishes a “public
database”

CPSIA
• Requires a company that uses metal
wicks to test and certify to their
customers that the metal is less than
0.06% lead
• Certification must be provided my
manufacturers to retailers or
distributors
• Increases maximum penalties from
$1.25 million to $15 million

CPSIA Public Database
• Consumers, physicians, public officials can
submit reports of harm to the CPSC via
internet or telephone on any consumer
product
• Must provide details on the product,
manufacturer and the harm caused
• Manufacturers are informed have a
comment period to respond to allegations
• Publically searchable, reports not verified
• Concerns for reliability of information and
how the data will be used

Product Recalls U.S.
• If a product contains a defect which
creates a product hazard or a risk of
serious injury or death
• Must IMMEDIATELY report to the CPSC
• Must include details of the product,
defect, injuries, sales, dates etc
• https://www.cpsc.gov/cgibin/sec15.aspx

Product Recalls - Canada
• No mandatory recall process, all recalls
are voluntary
• Products should be recalled if it is
determined that a product is unsafe
• Recalls are company driven
• Health Canada should be informed when a
safety related recall is initiated by a
company
• Canadian recall guidance is found at:
http://www.hc-sc.gc.ca/cps
sc.gc.ca/cps-spc/advisories-
avis/child-enfant/recalling
enfant/recalling-guide-2005-04-
rappel-eng.php
eng.php

Canada Proposed Regulations
• Canada Consumer Product Safety Act (Bill
C-6) was introduced in January 2009
• Prohibited sale of dangerous products,
mandated labeling and reporting
requirements, authorized recall powers,
increased monitary fines, required
products meet established standards
• Bill did not pass
• Likely to be reintroduced in the near
future

Europe
• The General Product Safety Directive,
2001/95/EC is the EU regulation
governing consumer products
• Producers/distributors that become aware
that a product poses risks to the
consumer shall immediately inform the
competent authorities of the Member
States
• http://ec.europa.eu/consumers/
safety/rapex/contact_points.pdf

Europe
• The competent authorities of the member
states alert the commission which in turn
alerts the other EU states through a system
called the Community Rapid Information
System (RAPEX)
• RAPEX shares information on serious
product safety issues and recalls
• RAPEX information and recalls are found at
http://ec.europa.eu/consumers/dyna/rapex
/rapex_archives_en.cfm

IMPLEMENTATION OF GHS

What are we going to cover?
• UN – GHS Background
• US Status and Implementation of
GHS
• Global Implementation of GHS (to
date)

UN - GHS
BACKGROUND

International Mandate from UN Conference on
Environment and Development (UNCED) – aka
“Earth Summit” - 1992
“A A globally harmonized hazard
classification and compatible labeling
system, including material safety
data sheets and easily
understandable symbols, should be
available, if feasible, by the year
2000”

GHS – What is it?
• GHS – an acronym for Globally
Harmonized System of Classification and
Labeling of Chemicals
• A document (not a regulation or directive)
• Provides a logical and comprehensive
approach to:
• Defining health, physical, and environmental
hazards of chemicals
• Create a classification process using available
data on chemicals
• Communicate hazard information & protective
measures on labels & SDS’s

GHS – Guiding Principles
• Protection will not be reduced
• Based on intrinsic hazards of
chemicals
• All types of chemicals will be covered
• All systems will have to be changed
• Involvement of all stakeholders
should be ensured
• Comprehensibility must be addressed

Existing Systems Used to Develop
GHS
• Included:
• UN Transport Recommendations
• U.S. Requirements for Workplace,
Consumer, and Pesticides
• EU DSD/DPD
• Canadian Requirements for Workplace,
Consumers, and Pesticides

A Brief Timeline
• 1992 – an international mandate adopted at the
UN Conference on Environment & Development
(UNCED)
• 1999 – scope is expanded to include transport of
DG
• 2002 – implementation plan – encouraged
countries to implement GHS ASAP – fully
operational by 2008 – World Summit on
Sustainable Development (WSSD)
• 2003 – 1 st edition of the GHS published –
(affectionately referred to as “The Purple Book”)
• 2009 – US-OSHA publishes NPRM - GHS

Is it necessary to harmonize?
• Global chemical business - >$1.7
trillion/yr
• US – $450 billion/exports >$80
billion/yr
• Sector-specific regulations – i.e.:
transport, workplace, and consumer
products; etc.

GHS – One system to cover all …..
Using the same criteria –
World-wide
Protect potentially exposed
• Workers
• Consumers
• Emergency responders
• Public

An example of the difference between country/classification

As you can see……
• DOT
• Flammable = 0 – 140 F
• Combustible = 140 – 200 F
• WHMIS
• EU
• Division 2 Flammable = 0 – 100 F
• Division 3 Combustible = 100-200 F
• Extremely/highly/flammable = 0 – 131F
• OSHA HCS
• Flammable = 0-1000
F
• Combustible = 100 – 200 F

What does this mean
• Flammable liquids – covered by most
existing systems
• The same product can be hazardous
or non-hazardous, depending where
you are – different labels/SDS
SDS’s
required
• The Goal – GHS will resolve this as
all will use the same criteria to
classify chemical

How will GHS help?
GHS Category 1
Criteria (flash point)

GHS – 3 major hazard groups
• Physical hazards
• Health hazards
• Environmental hazards
• Within each hazard group –
classes/categories
• Each class/categories = building block
• Select correct building block and apply
corresponding GHS rules for
classification/labels

GHS Health Hazard Categories
• Acute toxicity
• Skin corrosion/irritation
• Serious eye damage/eye irritation
• Respiratory or skin sensitization
• Germ cell mutagenicity
• Carcinogenicity
• Reproductive toxicology
• Target organs – SE
• Target organs – RE
• Aspiration toxicity

Physical Hazards Categories
• Explosives
• Flammable gases
• Flammable aerosols
• Oxidizing gases
• Gases under pressure
• Flammable liquids
• Flammable solids
• Self-reactive
substances
• Pyrophoric liquids
• Pyrophoric solids
• Self-heating
substances
• Oxidizing liquids
• Oxidizing solids
• Organic peroxides
• Corrosive to metals
• Contact with water
emit flammable gases

Environmental Hazards Categories
• Hazardous to the Aquatic
Environment
• Acute aquatic toxicity
• Chronic aquatic toxicity
• Bioaccumulation potential
• Rapid degradability

All Chemicals in the Workplace
must be Classified
• Once classified, specific signal words,
hazard statements and
symbols/pictograms are required for
each hazard class and category
• These elements must appear on the
label

Pictograms
• Examples – not all cat. have symbols

Hazard Statements
• Prescribed for each classification, for
example:
GHS Class
ATO 1,2
ATO 3
ATO 4
ATO 5
GHS HS Text
fatal if swallowed
toxic if swallowed
harmful if swallowed
may be harmful if
swallowed

2 Signal Words
• Danger and Warning
• Danger – most serious
• Warning – less serious
• Must appear on MSDS and label

UN - GHS
US Status &
Implementation of
GHS

What’s s OSHA Up To?
• September 30, 2009 – OSHA released
NPRM to modify the existing Hazard
Communication Standard (29 CFR
1910.1200) to incorporate GHS
• ~90 day comment period – 12/30/09
• Currently reviewing comments (700
received)
• Final rule expected 18 months (minimum)
after the NPRM ~March 2011
• NPRM based on Revision 3 of the UN GHS

What’s s changing?
• All provisions of GHS adopted
except:
• Acutely toxic – oral, dermal, inhalation
where LD50 = 2000-5000 mg/kg
• Skin corrosion/Irritation Cat. 3 –”causes
mild skin irritation”
• Aspiration hazard Cat.2 – maybe
harmful if swallowed and enters lungs
• All “Hazardous to the Environment”
categories (EPA)

What’s s outside scope of GHS but
retained or added by OSHA?
• OSHA term - “unclassified hazards”
• Combustible dust
• Cryogenic materials
• Simple asphyxiant (new)

What else?
• Material Safety Data Sheet/MSDS =
Safety Data Sheet/SDS
• 16 point MSDS allowed but not
enforcing sections 12-16
16
• Currently – 90 days to update
information on label/MSDS for
downstream users – proposed to be
lifted

Implementation
• 2 year transition period for
training
• 3 years for manufacturers,
importers, distributers
• Full compliance by 2014

Global Implementation of GHS
Finally!

The following countries have
implemented GHS or are in the
process of implementation
• Australia
• China
• Hong Kong
• India
• Indonesia
• Japan
• Korea
• Malaysia
• New Zealand
• Philippines
• Singapore
• Taiwan
• Vietnam
• EU
• Russia
• South Africa
• Brazil
• Mexico
• Canada
• USA

Implementation Dates
• Vary
• Different compliance dates for
substances/mixtures
• Run parallel systems

Summary
• The concept of GHS was born in 1992 at
the Earth Summit
• It provides a framework for countries
without chemical safety regulations to
develop one
• It provides the tools needed to revise
existing chemical safety regulations
• It provides a prescribed system to classify
and label hazardous chemicals which is
intended to be implemented by all users

The End – Thank you!
Eileen Hedrick
Corporate Vice President
Regulatory Affairs and
Fragrance Safety
Belmay, Inc

Research Institute for Fragrance
Materials, Inc. (RIFM)
• What is RIFM?
• RIFM is “THE” International Scientific
Authority for the Safe Use of Fragrance
Materials

RIFM
• What does RIFM do?
• RIFM’s s purpose is to gather and analyze scientific data,
engage in testing and evaluation, distribute information,
cooperate with official agencies and to encourage
uniform safety standards related to the use of fragrance
ingredients.
• What doesn’t RIFM do?
• RIFM does NOT establish ingredient standards

IFRA 45 th Amendment

RIFM Expert Panel
An independent* & internationally respected
Panel of Experts comprised of:
• Dermatologists
• Pathologists
• Toxicologists
• Environmental Scientists
*having no ties to the fragrance industry

RIFM Expert Panel (REXPAN)
• Advises RIFM on its strategic approach,
reviews protocols and evaluates all
scientific findings.
• The conclusions of the Expert Panel form
the basis for the Standards set by the
International Fragrance Association
(IFRA).

International Fragrance Association
(IFRA)
• IFRA is the GLOBAL representative body
of the fragrance industry.
• What is the Main Purpose of IFRA?
• To ensure the safety of the consumer and the
environment through a dedicated science
program.

Fragrance Safety Standards
• The Fragrance Industry is self–
regulated.
• Self-regulation enables the IFRA
standards to be adopted very rapidly
by fragrance houses worldwide and by
the industry as a whole.

Hazard / Risk / Exposure
What is Hazard?
“Hazard” is the harm that something can cause. The harm may be
physical injury, damage to health, property and/or the environment.
What is Risk?
“Risk” is the likelihood that a hazardous material will cause harm to
people, property or the environment.
What is Exposure?
“Exposure” is the extent to which people or objects are subjected to the
hazard. it can be influenced by factors such as the length or duration of
exposure (short versus long), how much exposure (high concentration
versus low) and/or the route of exposure (inhalation versus skin contact
versus ingestion).

Quantitative Risk Assessment (QRA)
• This new methodology is a major improvement
improvement over former risk assessment
practices because it specifically addresses the
elements of exposure based risk assessment that
are unique to the induction of dermal
sensitization.
• The QRA addresses the protection of human
health and is specifically aimed at ideally
eliminating the acquisition of dermal sensitization
of fragrance ingredients under conditions of use.
• QRA was introduced with the 40 th Amendment to
the IFRA Code of Practice.

IFRA Categories
• Prior to the QRA approach there were two
product categories:
• Skin Contact
• Non-skin Contact
• Under previous risk management strategies used
by IFRA each specific fragrance raw material
identified as an allergen was limited to the same
concentration across all skin contact product
types. This is no longer considered sufficient.
• With QRA there are now 11 Categories and a
total of 23 Classes

IFRA Categories/Classes/Groupings
• The IFRA QRA approach for fragrance ingredients
uses multiple product categories for the
implementation of IFRA Standards.
• This is achieved by grouping consumer product
types according to key parameters identified
within the QRA approach. These parameters are
Sensitization Assessment Factors (SAFs) and
consumer product exposure, which when
combined, lead to similar acceptable use levels of
a fragrance ingredient.

Category 11
Non-Skin / Incidental Skin Contact
Due to the expected insignificant skin exposure
from products grouped in this Category the risk of
induction of dermal sensitization through the
normal formulation and use of such products is
considered negligible.
As such, the concentration of fragrance ingredient
is not restricted in the finished product.

Category 11
Non-Skin / Incidental Skin Contact
• Air Fresheners of all types
• Animal Sprays
• Candles
• Cat litter
• Deodorizers/Maskers (e.g.
fabric drying machine
deodorizers, carpet powders)
• Floor wax
• Fragranced lamp ring
• Fuels
• Insecticides (e.g. mosquito coil,
paper, electrical, for clothing)
• Joss Sticks or Incense Sticks
• Machine Dishwash Detergent
and Deodorizers
• Machine Only Laundry
Detergent (e.g. liquitabs)
• Odored Distilled Water
• Paints
• Plastic articles (excluding
toys)
• Reed diffusers
• Scratch and sniff
• Scent pack
• Shoe Polishes
• Toilet Blocks
• Treated Textiles (e.g. starch
sprays, fabric treated with
fragrances after wash, etc.)

IFRA 45 th Amendment
• Three new Standards, based on the QRA
‣ Dimethylcyclohex-3-ene-1-carbaldehyde (mixed isomers)
68737-61-1 - Vertocitral
68039-49-6 -Triplal / Cyclal / Cyclal C
68039-48-5 - Agrumen Aldehyde
27939-60-2 - Tricyclal
67801-65-4 - Cyclovertal
‣ alpha-Methyl-1,3-benzodioxole-5-propionaldehyde
1205-17-0 – Helional / Tropional
‣ Phenylbutanal
16251-77-3 - Trifernal

IFRA 45 th Amendment - continued
• One revised Standard on Verbena absolute (Lippia citriodora)
CAS No 8024-12-2 , based on the QRA
• One revised Standard - 2,2-Dimethyl-3-(3-tolyl)propan-1-ol
(Majantol)
• with specifications regarding presence of organochlorides
• One new Standard on Musk ketone with specifications
regarding presence of Musk xylene
• Musk ketone can contain traces of musk xylene, which has been
prohibited as part of the 44 th Amendment. It has therefore been decided
to set a specification Standard, asking that the level of musk xylene in
musk ketone be kept below 0.1%, which is consistent with current IFRA
policy regarding the presence of trace substances in fragrance materials.

IFRA 45 th Amendment - continued
• One new Standard prohibiting the use of Quinoline (CAS No
91-22-5)
• The material has been officially classified CMR II (GHS CMR
1B) and had only minor reported use.
• Future Amendments to the IFRA Code of Practice (beyond
2010):
• Beyond 2009, future Amendments to the IFRA Code of Practice
will include new IFRA Standards (where none previously
existed) on fragrance ingredients from the RIFM Database and
will also include those existing IFRA Standards based on the
QRA approach that are scheduled for their 5-year review or for
which significant new data are available

RIFM CANDLE STUDY
• The aim of the study was to investigate the
dermal exposure to fragrance materials from
scented candles, whether occurring intentionally
or unintentionally.
• A simple hand wipe sampling and analysis
procedure was used to determine the human
dermal exposure to three fragrance materials
(Cinnamic aldehyde, d’Limonene d
and Eugenol)
commonly used in candles.
• Pillar scented candles (3” in diameter x 6” 6 in
height) containing 5% fragrance mixture were
used.

Hand Transfer
• 10 subjects washed their hands with non-fragranced soap &
tap water, rinsed well and dried their hands with paper
towels.
• They then grasped a new candle one at a time in each
hand, and held the candles for ~20 seconds.
• The hands of the subjects were then wiped with dressing
sponges containing isopropyl alcohol.
• This procedure was repeated 4 additional times for a total
of 5 exposures. After each exposure, palms were wiped
with the dressing sponges containing IPA and the samples
were analyzed

Results
• In all subjects the residue of d’Limonene d
transferred to the
hands from the candles was below the limit of
quantification.
• The residue of Cinnamic aldehyde and Eugenol transferred
to the hands was consistent from subject to subject and
from round to round and was considered to be minimal.
• Based upon this study it was apparent that exposure to
fragrance materials tested during short-term term consumer
handling of scented candles does not pose a significant
human dermal sensitization risk.

No-Observed Effect-Level
• Using RIFM (NOELs), a significant safety
factor exists between the measured
exposure concentration for human skin
contact from scented candles and the
NOEL for the induction of dermal
sensitization in humans for all three
fragrance materials.

IFRA Compliance Program
• The IFRA Compliance Program was voluntarily created to ensure
that fragranced consumer products are in strict compliance to the
IFRA Code of Practice and ensuing ingredient standards.
• It involves the analysis of a variety of consumer products for the
presence of fragrance ingredients regulated by IFRA Standards.
• In order to assure confidentiality and impartiality this is
accomplished through the use of an independent laboratory.
• The fourth cycle of the IFRA Compliance Program covering the
period May 2009 to April 2010,found no IFRA banned substances
in any of the selected products*. A test sample of fifty fragranced
products, chosen at random from a selection of 450 marketed
products from ten different countries, found that all fragrance
formulations were compliant with the IFRA Code of Practice.
(*FF, body care, household)

RIFM / IFRA Alliance
• The RIFM/IFRA alliance allows for coordination of
information & action from the scientific body to
the advocacy needs of our industry.
• This alliance promotes industry expertise in
fragrance safety based on sound science.
• Communicates informed scientific data to official
agencies and other interested parties.