role of fragrances in johnson’s® aby products · 2 objectives define and explain fragrances...

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Role of Fragrances in JOHNSON’S® Baby Products

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Objectives

Define and explain fragrances

Discuss the importance of the sense of smell in infant wellness and in healthy physiological and emotional development

Identify benefits associated with fragrances

Discuss how the safe use of fragrances is assessed by respected international third-party groups

Review how JOHNSON’S® standards ensure that the fragrances used in its products are safe and appropriate for baby

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Table of Contents

Understanding the Role of Fragrance in Culture and Society

Importance of the Sense of Smell in Infant Wellness and in Healthy Physiological and Emotional Development

Benefits of Including Fragrance in Personal Care Products for Baby

– Understanding the Potential Limitations of Fragrance for Some Consumers

The Safe Use of Fragrances Is Assessed by Respected International Third-Party Groups

JOHNSON’S® Standards Ensure that Fragrances Used Are Safe and Appropriate for Baby

Summary and Conclusions

Appendix

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Understanding the Role of Fragrance in Culture and Society

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In ancient Near East, most prized incense from the fragrant cedar of Lebanon

Ancient Babylonians used resins from the pine, cypress, and fir, as well as juniper berries and gum galbanum

3000 BC 2000 1000 0 2000 AD

Maker of perfume first recorded on cuneiform tablet, 2nd millennium BC

Ancient Egyptian depiction of preparation of lily perfume, 2100 BC

At the time of Christ, frankincense, myrrh, and gum labdanum (pictured) burned in the temple

First treatise on scent written by Theophrastus around 300 BC

In India, Gandhika (perfume dealer) sells scents for Spring festival of Holi, 500 AD

9th century Arab philosopher Yakub ibn Ishak al-Kindi writes The Book of Perfume Chemistry and Distillations

Romans make extensive use of fragrances, with special glass flasks to hold essences

1000 1500

The first modern perfume created in Hungary at request of Queen Elizabeth of Hungary in 1370

Distillation described in the writings of Michael Savonarola of Italy in early 1400s

Adam Lonitzer publishes treatise on fragrance, Herbal, in 1577

Eau de cologne created by Feminis, early 1700s

Advances in organic chemistry in late 1800s leads to synthetic fragrances

Morris ET. Fragrance: The Story of Perfume From Cleopatra to Chanel. New York, NY: Charles Scribner's Sons; 1984.

History of Fragrance: Development of Fragrances From Ancient Civilization to the Present

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Fragrance: Understanding the Complexity

Fragrances or fragrance compounds are ingredients added to products to impart a scent.1

Fragrances themselves can consist of a single molecular entity, but usually consist of mixtures of hundreds of different molecules.2

The molecules and/or mixtures of molecules that are used in fragrances for personal care products should be well-known and well-tested chemicals.3

1. Stehlin D. FDA Consumer. November 1991;(9) (revised 1995). 2. Sell CD, ed. The Chemistry of Fragrances: From Perfumer to Consumer. 2nd ed. Cambridge, England: The Royal Society of

Chemistry; 2006. 3. Schroeder W. Cosmetics Toiletries. November 2009;124:36-44.

Defining Fragrance: The Science of Scents

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x

Individual Fragrance Molecules

Fragrance Blend or

Formulation

Fragranced Product

x

x

y z

X Y Z = Other ingredients

scent 1

scent 2

scent 3

Fragrance ingredients: > Many different chemical structures > 20 different chemical structural groups.1

Unique quality of a fragrance formulation depends on selection and relative concentration of different molecules and/or mixtures of molecules

Differences in fragrance formulations account for different scents

1. Research Institute for Fragrance Materials. http://www.rifm.org. 2. Sell CD, ed. The Chemistry of Fragrances: From Perfumer to Consumer. 2nd ed. Cambridge, England: The Royal Society of Chemistry; 2006.

Individual Fragrance Formulations Are Unique

http://www.rifm.org/

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Fragrances Are Classified Into 3 Groups

Essential oils

Complex blend of natural chemicals (volatile or ethereal)*

Extracted from plants (leaves, flowers, stems, roots, bark)

Not true oils

Prepared by distillation, cold pressing, or extraction

Natural fragrances

Fragrance wholly composed of 1 or more molecular entities derived or purified from natural sources

Synthetic fragrances

Fragrance wholly composed of 1 or more molecular entities derived from a synthetic chemical reaction

Can mimic a molecule derived from a natural source or can be a novel molecule

Expand the palate of scents

*Volatile or ethereal in chemistry refers to the tendency of a substance to vaporize.


Classification of Fragrances

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Synthetic Fragrances

Man made


Natural Fragrances

Derived from natural sources

Natural and Synthetic Fragrances Share Characteristics

Can have the same chemical structure

– Natural identical can be structurally identical to a natural molecule

Have scientific evidence supporting safety

– Both natural and synthetic fragrances, including novel fragrances, have a documented safety profile

– Molecules with the same chemical structure have the same safety profile

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Experiential Basis of Fragrance1

Fragrance is tied to emotions.

Olfactory stimuli send signals that project to the limbic system1-3

– Ancient core system involved in emotional expression

Induce pleasant or unpleasant experiences, depending on odor3,4

Fragrances can evoke memories.

Recall of events or objects associated with specific odors5

– Memories triggered by odors significantly more emotional and evocative than those triggered by visual or auditory cues6

– Smells are linked to autobiographical episodes7

1. Van Toller S, Dodd GH, eds. Perfumery: The Psychology and Biology of Fragrance. New York, NY: Chapman and Hall; 1988. 2. Kivity S, et al. Isr Med Assoc J. 2009;11:238-243. 3. Gottfried JA, et al. J Neurosci. 2002;22:10819-10828. 4. Bensafi M, et al. J Neurophysiol. 2007;98:3254-3262. 5. Gottfried JA, et al. Neuron. 2004;42:687-695. 6. Herz RS. Chem Senses. 2004;29:217-224. 7. Larsson M, Willander J. Ann N Y Acad Sci. 2009;1170:318-323.

Fragrance Evokes Experience

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Stage Benefit of Fragrances

Before birth Plays possible role in organizing brain and developing social capacities1

Neonates and infants Plays important role in bonding with mother2,3

Mother’s scent has soothing effect, prepares infant for feeding4

Can help infant prepare for sleep4

Adults Improves calmness, alertness, mood, and reduces stress5-7

Closely tied to emotional responses1

1. Kivity S, et al. Isr Med Assoc J. 2009;11:238-243. 2. Sullivan RM, et al. Pediatrics. 1991;87:511-518. 3. Leon M. Annu Rev Psychol. 1992;43:377-398. 4. Sullivan RM, Toubas P. Biol Neonate. 1998;74:402-408. 5. Chen D, Dalton P. Chem Senses. 2005;30:345-351. 6. Warrenburg S. Chem Senses. 2005;30(suppl 1):i248-i249. 7. Chu S. Chem Senses. 2008;33:65-71.

Fragrances Can Be Associated With Benefits at Every Stage of Life

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1. Bridges B. Flavour Fragrance J. 2002;17:361-371.

Fragrance Might Not Be Appropriate for All Individuals

Thousands of fragrances are currently in use

– Spanning wide range of products (eg, cosmetics, toiletries, household products)

For certain individuals fragrance may not be appropriate1

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Place holder for slide addressing allergic contact dermatitis as suggested by Dr Fowler.

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Ingredients added for the sole purpose of imparting scent are listed on the product label as “fragrance.”

Hand Sanitizer

Adult Facial Cleanser

Adult Shampoo

Stehlin D. FDA Consumer. November 1991;(9) (revised 1995). Personal Care Products Council. http://www.personalcarecouncil.org. Bridges B. Flavour Fragrance J. 2002;17:361-371. Lewis C. FDA Consumer. May-June 1998;32(3) (revised May 1998 and August 2000).

Globally, regulatory agencies recognize that since individual fragrances contain more than one ingredient, it is not practical to include each ingredient on the product label.

Understanding “Fragrance” on Product Labels

http://www.personalcarecouncil.org/

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1. Stehlin D. FDA Consumer. November 1991;(9) (revised 1995).

Understanding the Terms “Fragrance-Free” and “Unscented” on Product Labels

Fragrance Labeling: A Question of Function

Products labeled “fragrance-free” can still contain ingredients that impart scent, as long as those ingredients are added for another purpose, including:

– As a preservative

– To mask scents associated with other ingredients

“Unscented” means that a product has been formulated to have no scent

– The product can still contain fragrance molecules

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Government Role in Regulating Labeling1-3

United States

Ingredients must be declared using standardized nomenclature (INCI) [with the exception of individual ingredients added solely to impart scent, which are labeled as “fragrance”] and safety must be adequately substantiated before marketing or must carry warning label

Europe Similar to the United States, with exception that certain fragrance ingredients suspected of causing sensitization must be listed individually if concentration is above specified levels in the final product

Industry Standards2

PCPC (CTFA), IFRA Set standards for safety and work with individual companies to ensure compliance; standardize nomenclature via INCI

CTFA, Cosmetic, Toiletry, and Fragrance Association; IFRA, International Fragrance Association; INCI, International Nomenclature Cosmetic Ingredient; PCPC, Personal Care Product Council. 1. Personal Care Products Council. http://www.personalcarecouncil.org. 2. Bridges B. Flavour Fragrance J. 2002;17:361-371. 3. Lewis C. FDA Consumer. May-June 1998;32(3) (Revised May 1998 and August 2000).

Industry and Government Collaborate to Ensure Accuracy in Fragrance Labeling

http://www.personalcarecouncil.org/

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Understanding the Role of Fragrance in Culture and Society: Summary

History of Fragrance

Deep historical and cultural roots

Evolved from natural ingredients to synthetics

Defining Fragrance

Chemical basis: many ingredients, well-known and well-tested chemicals

Fragrances contain molecules and/or mixtures of molecules specially formulated to impart a unique scent

Experiential basis: scent evokes an experience, tied to emotions

Characteristics of Natural and Synthetic Fragrances

Natural and synthetic fragrances are well-understood and well-characterized molecules

Natural and synthetic fragrances can have same chemical structure and safety profile

Benefits of Fragrance

Associated with benefits at every stage of life: birth (mother-infant bonding) to later stages (improve calmness, alertness, mood, reduce stress)

– For some individuals fragrance might not be appropriate

– Fragrance-free or “unscented” products might contain fragrance molecules used for other purposes (eg, to preserve the product or to mask other scents)

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Importance of the Sense of Smell in Infant Wellness and in Healthy

Physiological and Emotional Development

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Kivity S, et al. Isr Med Assoc J. 2009;11:238-243.

The Olfactory System and Sensory Organ

Olfactory system

– Sensory organ (the olfactory epithelium and bulb)

– Specific olfactory brain regions (the primary and secondary olfactory cortex)

Odor sensory organ

– Can detect many thousands of scents based on minute airborne concentrations of a chemical substance

– Unlike smell, other senses including hearing, vision, and touch are stimulated by frequencies of sound, light, and pressure in a predicted linear manner

Odorant molecules

– Need to be volatile so that they can vaporize (size range 200-400 Da)

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1. Kivity S, et al. Isr Med Assoc J. 2009;11:238-243. 2. Zelano C, Sobel N. Neuron. 2005;48:431-454.

Smell Differs From Other Senses in Important Ways

Sense of smell played key role in human adaptation and survival from the earliest periods of evolution1

– Olfactory areas of cortex phylogenetically older than those of other senses

Contact between the external environment and the brain is more direct compared with other senses2

– Signals triggered by the sense of smell are transmitted directly to the brain via the olfactory bulb

– Signals triggered by other senses (sight, hearing, touch) are processed through the thalamus (serving as gate keeper)

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1. Kivity S, et al. Isr Med Assoc J. 2009;11:238-243. 2. Willander J, Larsson M. Mem Cognit. 2007;35:1659-1663.

Proust Phenomenon*

“Slightest hint of perfume can transform the present into the past, it can recreate entire sensory experiences by providing an emotional link between past events initially experienced th[r]ough separate senses, and it can make memories seem real and tangible”1

*Based on the novelist’s work Remembrance of Things Past, in which the author describes being transported by the aroma of dipping a cake into his tea.

Sense of Smell Is Linked With Memory and Emotions

Olfactory stimuli1

– More potent cues of autobiographical memories than other sensory stimuli

Olfactory-memory relationship2

– Anatomical overlap between the structures involved in memory process and olfaction pathways

– Orbitofrontal cortex: receives already processed sensory information (gustatory, olfactory, auditory, and visual) and integrates into unified perceptions

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Area Role of Smell

Brain Development and Learning

Olfactory learning occurs before birth and helps develop social capacities1,2

Infants attach meaning to familiar smells within first hours after birth3

Social Development and Functioning

Odor important in human mother-infant bonding5-7

Mother’s scent (both natural odor and fragrance) has soothing effect on infants, prepares infant for feeding8,9

Scents prepare for sleep8

Mood and Cognitive Functioning

Pleasant odors improve calmness, alertness, and mood10,11 and reduce stress12

1. Kivity S, et al. Isr Med Assoc J. 2009;11:238-243. 2. Schaal B, et al. Chem Senses. 2000;25:729-737. 3. Sullivan RM, et al. Pediatrics. 1991;87:511-518. 4. Willander J, Larsson M. Mem Cognit. 2007;35:1659-1663. 5. Moriceau S, Sullivan RM. Dev Psychobiol. 2005;47:230-242. 6. Leon M. Annu Rev Psychol. 1992;43:377-398. 7. Cernoch JM, Porter RH. Child Dev. 1985;56:1593-1598. 8. Sullivan RM, Toubas P. Biol Neonate. 1998;74:402-408. 9. Rattaz C, et al. J Dev Behav Pediatr. 2005;26:86-92. 10. Weber ST, Heuberger E. Chem Senses. 2008;33:441-447. 11. Chen D, Dalton P. Chem Senses. 2005;30:345-351. 12. Warrenburg S. Chem Senses. 2005;30(suppl 1):i248-249.

Sense of Smell Is Fundamental to Human Development and Functioning

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Moriceau S, Sullivan RM. Dev Psychobiol. 2005;47:230-242.

Sense of Smell Is Important for Mother-Infant Attachment: Lessons From Animal Studies

Infant maternal odor preference learning is necessary for survival (nipple attachment, huddling, orientation)

– Unique neural circuitry underlying infant learning

– Enhanced preference learning for the maternal odor

– Blocks aversion learning that would interfere with attachment to the mother

Neuronal connections not simply due to the absence or immaturity of brain structures, but rather to the brain having unique characteristics

– Olfactory bulbs encode learning

– Noradrenergic locus coeruleus is both necessary and sufficient for the preference learning

– Lack of amygdala participation underlies attenuated aversion learning

Noradrenergic-dependent learning is similar to neural basis of other survival behaviors in reproduction across species

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Sullivan RM, et al. Pediatrics. 1991;87:511-518.

Learned Response to Odor at 48 Hours After Birth

Infants Learn to Respond to Important Odors Rapidly After Birth and Respond Better When Odor Is Combined With Touch

Infants (N=66) were randomly assigned to 1 of 4 groups :

– Odor and stroking (touch) concurrently

– Stroking followed by odor

– Odor alone

– Stroke alone

48 hours after birth, 48 infants (12 in each group) were exposed to odor

Combined odor and stroking group showed complex learned response to the odor within 48 hours after birth

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Cernoch JM, Porter RH. Child Dev. 1985;56:1593-1598.

*P<0.05 vs unfamiliar nonlactating woman. †P<0.01 vs unfamiliar lactating woman.

Tim

e O

rien

ted

to

Od

or

(Mea

n, s

ec)

62.5*

42.0

72.9†

37.1

n=13 n=16

Mean Time Infants Spent Oriented to Odor of Mother Versus Odor of Unfamiliar Women

Smell Contributes Along With Other Senses to Mother-Infant Bonding

Conclusion:

Infants were significantly more familiar with odor of mother compared with odor of unfamiliar women suggesting that

– Smell contributes to mother-infant bonding

– Infants programmed to detect mother’s odor as survival instinct

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Importance of the Sense of Smell

Key role in adaptation and survival from earliest period in human evolution

Olfactory areas of cortex phylogenetically older than other senses

Smell only sense with direct neuroanatomical contact with external environment

Smell more attuned to pleasure than other senses

Fundamental to human development and functioning

Develops prenatally and rapidly adapts after birth

Plays a central role in memory and emotion

Contributes along with other senses to mother-infant bonding

Mother’s odor or fragrance associated with mother combined with touch has soothing effect on infant

Importance of the Sense of Smell: Summary and Conclusions

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Benefits of Including Fragrances in Personal Care Products for Baby

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1. Knasko SC. Chem Senses. 1995;20:479-487. 2. Warren C, Warrenburg S. Perfumer Flavorist. 1993;18:9-16. 3. Van Toller S, Dodd GH, eds. Perfumery: The Psychology and Biology of Fragrance. New York, NY: Chapman and Hall; 1988:chap 11. 4. Saab TD. Accommodation and compliance series: employees with fragrance sensitivity. http://www.jan.wvu.edu/media/fragrance.html.

Fragrances in Personal Care Products Confer Benefits

Fragrance in personal care product associated with improved sense of well-being and mood1,2

– Fragrances can fulfill positive emotional associations3

Fragrances may be necessary in products to mask unpleasant odors of other essential ingredients4

http://www.jan.wvu.edu/media/fragrance.html

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Data Collection Schedule

Assessment of Behavioral Cues

NCATS, Nursing Child Assessment Teaching Scale.

White-Traut RC, et al. Poster presented at: Third National Congress on the State of the Science in Nursing Research; October 7, 2004; Washington, DC.

Fragranced Baby Bath Product Enhances Engagement Between Mother and Infant

Design: Study in home setting conducted on 23 mother-and-infant pairs

Objective: Evaluate behavioral responses to bathing with a fragranced bath wash compared with water alone

Methods:

– Bath observations made during 2 home visits (bath order randomly assigned)

– Assessment of behavioral cues (level of engagement) made before and after bathing

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Observed Potent Engagement* in Infants Before, During, and After Bathing

Enga

gem

ent

Sco

re (

Mea

n)

6

7

8

9

10

Before Bath Educational

Activity

During Bath

Drying and Clothing

After Bath Educational

Activity

Nonfragranced Control Fragranced Bath Wash

*Potent engagement cues included facial gaze or focus, mutual gaze, smile, verbalization, smooth cyclic movements of extremities.

White-Traut RC, et al. Poster presented at: Third National Congress on the State of the Science in Nursing Research; October 7, 2004; Washington, DC.

Bathing With Fragranced Bath Product Enhances Engagement Between Mother and Infant

Bathing with fragranced bath product resulted in 30% more potent engagement cues after bath versus nonfragranced control

– Fragranced bath associated with sustained increase in observed potent engagement after bath

– Nonfragranced control associated with sustained decrease in observed potent engagement after bath

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Johnson & Johnson Consumer. Method for relaxing human beings using personal care compositions. Patent/publication 6830755. http://www.micropat.com.

Effects of Bathing With Bath Products With Sensory Fragrances

Design: 30 infants (ages 1 week to 4 months) took part in 3 separate bathing studies

– In each study, 10 infants received baths: 5 using a bath product with sensory fragrance and 5 using a bath product without sensory fragrance

Objective: To assess the effect of bath products on level of relaxation, engagement, and sleep behaviors in infants

Methods:

– Study 1: salivary cortisol levels taken before and 20 minutes after bath to measure relaxation level

– Study 2: bathing procedure videotaped and frequency of engagement behaviors scored

– Study 3: bathing procedure done and infant put down to sleep in quiet place and sleep behaviors (eg, latency to sleep, sleep stages) observed

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Change in Salivary Cortisol Level From Baseline

-20

-10

0

10

20

Sensory Fragrance Group

No Sensory Fragrance Group

-15.4 ± 19.7*†

+1 19.6 ± 29.3

*Significant vs baseline cortisol level at 94% CI. †Significant vs no sensory fragrance group at 98% CI.


% C

han

ge in

Sal

ivar

y C

ort

iso

l Lev

el

Bathing With Sensory Fragranced Bath Product Increases Infant Relaxation

Bathing infants

With sensory fragranced bath product: significantly decreased salivary cortisol level from baseline

With bath product without sensory fragrance: significantly increased salivary cortisol level from baseline

Sensory fragranced bath products help infants to relax

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Infant Engagement With Mother: Percent Time Looking at Mother During Bath

0

20

40

60

80

100



Per

cen

tage

of

Tim

e

87.4 ± 5.9*

65.0 ± 26.8

*Significant vs no sensory fragrance group at 99% CI.


Bathing With Sensory Fragranced Bath Product Increases Infant Engagement

Bathing infants with sensory fragranced bath product significantly increased time infants spent engaging mother during bathing, compared with bathing infants with bath product without sensory fragrance.

Sensory fragranced bath product encourages infant engagement and bonding with mother

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0

10

20

30

40

50

60

0

10

20

30

40

50

Percentage of Time Infant Spent Crying Before Sleep

Percentage of Time Infant Spent in Deep Sleep

Per

cen

tage

of

Tim

e

Per

cen

tage

of

Tim

e


28.4 ± 30.8

52.1 ± 38.7 42.2 ± 15.8*

9.4 ± 17.3




*Significant vs no sensory fragrance group at 99% CI.


Bathing With Sensory Fragranced Bath Product Improves Infant Sleep Behaviors

Bathing with sensory fragranced bath product, compared with bathing with bath product without sensory fragrance

– Decreased time spent crying before sleep

– Significantly increased infant deep sleep time

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Luedtke K, Wiegand B, inventors; Johnson & Johnson, assignee. Method for improving sleep behaviors. US patent application 20070207220. Available at: http://appft.uspto.gov.

Bath Routine Including a Fragranced Bath Product Improves Infant Sleep and Mood

Design: 3-week study conducted in 58 healthy mother-infant pairs (infants ages 7-16 months)

Objective: To assess the effect of a bath routine including a fragranced bath product on infant sleep and mood

Methods:

– All infants were bathed daily for 2 weeks using a fragranced bath product followed by application of a fragranced lotion

– Assessments were made at baseline (Day 7), Day 14, and Day 21

• Brief Infant Sleep Questionnaire (BISQ)

• Infant Daily Sleep Questionnaire

• Profile of Mood States™

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*P<0.05 versus baseline.

Rating of Infant’s Mood in Morning Over Past Week

Length of Time to Sleep Onset at Night Over Past Week

*

Luedtke K, Wiegand B, inventors; Johnson & Johnson, assignee. Method for improving sleep behaviors. US patent application 20070207220. Available at: http://appft.uspto.gov.

Bath Routine Including a Fragranced Bath Product Improves Infant Sleep and Mood

Bath routine with fragranced bath product resulted in a 37% reduction in length of time to fall asleep versus baseline and significantly improved mood in the morning.

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Fragrances in personal care products confer benefits

For babies, personal care products with fragrance

– Enhance engagement between mother and infant

– Increases infant relaxation

– Improves infant sleep and mood

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The Safe Use of Fragrances Is Assessed by Respected

International Third-Party Groups

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FD&C, Federal Food, Drug, & Cosmetic Act; GRAS, Generally Recognized As Safe; RIFM, Research Institute for Fragrance. History of cosmetics and personal care products. http://www.cosmeticsinfo.org/history2.php.

1880 1920 1900 1940 1960 1980 2000

By 1900, US firms manufacturing perfumery and toilet goods increase to 262 from 67 in 1880

By 1900, cosmetics in widespread use by nearly all societies worldwide

1920: Cosmetics and fragrances mass marketed in US for the first time

1938: FD&C Act passed, fragrances under FDA authority

1958: FDA publishes first GRAS list with nearly 200 substances

1962: JFK announces the Consumer Bill of Rights

1966: US Congress enacts the Fair Packaging and Labeling Act, requiring products to be honestly and informatively labeled

RIFM (1966) and IFRA (1973) established by fragrance industry to assess and enforce safety of fragrances

1999: First Cosmetics Harmonization and International Cooperation meeting is held in Brussels, Belgium

Consumer Safety Regulations Evolved as the Consumer Market and Fragrance Industry Has Grown

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Meakins S. In: The Chemistry of Fragrances: From Perfumer to Consumer. 2nd ed. Cambridge, England: The Royal Society of Chemistry; 2006:184-197.

Fragrance Industry Recognizes the Need for Setting Strict Standards for Safety

More than 40 years ago, worldwide fragrance industry recognized the need to establish and enforce strict standards for safety

Realization that absence of regulation could expose consumer to risk

Adopted an industry-sponsored self-regulation model due to proprietary nature of fragrance formulations

Advantages of self-regulation

– Rapid and efficient adaptation of worldwide industry rules to new scientific findings

– Compliance policy to verify that standards are respected

This led to creation of RIFM in 1966 and IFRA in 1973

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Research Communication and Compliance

Conducts research in human and environmental health

Maintains safety database

Data used to set safe use levels

Maintains Fragrance Industry Code of Practice

Drafts and issues IFRA Standards

Ensures compliance globally

Research Institute for Fragrance Materials

Ladd A, et al. Perfumer Flavorist. 2006;30:46-51.

Two Global Organizations Work in Close Coordination to Ensure the Safety of Fragrances in Consumer Products

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Independent Research Organization Devoted to Evaluation of Safety of Fragrance Materials

Main Functions

– Provide comprehensive database for information on exposure and safe use of fragrance materials

– Convene Expert Panel to assess fragrance safety and provide guidance in developing IFRA safety standards

Mission

– Engage in research and evaluation of safety of fragrance materials

– Publish scientific findings and disseminate safety data and judgments to RIFM members and interested parties

– Maintain an active dialogue with official international agencies

Ladd A, et al. Perfumer Flavorist. 2006;30:46-51. Research Institute for Fragrance Materials. www.rifm.org.

RIFM Assesses Fragrance Safety

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Notification of Amended Standards

New or amended IFRA standards issued annually or as health or environmental risk warrants

Notification made to membership and trade associations

Manufacturers must inform customers within 60 days following effective date

Compliance

All IFRA members must strictly comply with Code

Manufacturer deemed in violation if it markets any noncompliant ingredient

IFRA uses analytical investigations (on randomly selected products) of fragrance composition for surveillance

Violators who fail to remediate are identified as noncompliant

Safety Evaluation

Ingredients must always conform to the requirements of law or regulation

Ingredients should only be used when they present no unreasonable risk to human health or environment and are safe under their intended conditions of use

Safety is assessed within the context of ongoing RIFM evaluation program

International Fragrance Association. http://ifraorg.org.

IFRA Code of Practices

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Cadby PA, et al. Flavour Fragrance J. 2002;17:472-477.

Contributions of IFRA and RIFM to Fragrance Safety

Based on FDA consumer complaint data on cosmetics during 1980s and 1990s

– Estimated fragrance allergy: 1 complaint per 1 million cosmetic units

Before the creation of RIFM, no formal independent process to evaluate the safety of fragrances

– Only in 1976 did EPA and European agencies require new chemicals to be registered and assessed for safety

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IFRA Scientific Committee

Roles in the safe use of fragrance materials: RIFM and IFRA’s process and guidelines for fragrance standards. Perfumer & Flavorist. Research Institute for Fragrance Materials, Inc.

RIFM Expert Panel

COMPANIES

RIFM


IFRA/RIFM Product Safe Use Cycle for Fragrances

LITERATURE REVIEW,

RESEARCH, AND TESTING

REQUESTS STANDARDS

(CODE OF PRACTICE)

SAFETY EVALUATION

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RIFM IFRA

Hazard and Risk Assessment Risk Management


IFRA and RIFM Work in Close Coordination to Assess and Manage Risk Associated With Fragrance Ingredients

Prioritization framework established for assessing risks for >4500 fragrance materials

– Necessary because many materials have low use levels

– Dependent on volume of use, product content, and toxicologic and environmental risk

Scoring system ranging from 0 to 48 based on worldwide use, content in goods, and the following chemical structural alerts:

– Topical (dermal) effects

– Systemic toxicity

– Environmental consequences

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Risk Assessment Studies1,2

Topical (dermal) effects

Skin irritation

Dermal sensitization

Phototoxicity (if ingredient absorbs UV radiation)

Systemic toxicity Repeated dose toxicity

Reproductive and developmental testing

Environmental consequences

Environmental basic data sets (measured or calculated)

1. International Fragrance Association. http://ifraorg.org. 2. Bickers DR, et al. Regul Toxicol Pharmacol. 2003;37:218-273.

RIFM Risk Assessment Approach for Fragrances

48


IFRA Has Adopted Quantitative Risk Assessment (QRA) for Dermal Sensitization of Fragrance Ingredients

QRA approach has been adopted and refined for assessing fragrance ingredients

– Core IFRA strategy for primary prevention of dermal sensitization

QRA methodology identifies concentration limits for various product types

– Product types are grouped into product categories according to similar safety assessment factors and exposure

– Acceptable use levels of a fragrance ingredient defined by category

– Exposure quantified as dose per unit area

– Exposure risk factors added for babies, placing baby products in more restrictive categories

QRA marks an advance in risk management strategy

49


Step Objective

1. Hazard Identification Determine the potential of a fragrance material to induce sensitization (hazard)

2. Dose-Response Assessment

Establish the relationship between dose (level of exposure) and the probability that an adverse effect will occur

3. Exposure Assessment Determine the amount of a fragrance ingredient that individuals will receive (dose or exposure)

4. Risk Characterization Establish acceptable exposure levels to fragrance ingredients (dermal sensitizers) in specific real-life consumer product types

Four Steps of QRA for Dermal Sensitization of Fragrance Ingredients

50


IFRA Standards Are Widely Accepted

Governments and their regulatory authorities have long recognized that legislation usually is not required on matters covered by generally recognized sector best practices, such as the IFRA standards

European Cosmetics Industry Association

– Asks for a certificate of IFRA compliance

Brazilian policy makers have adopted into law the IFRA standards

South East Asia Pacific cosmetic directive

– Explicitly refers to the IFRA standards

Chinese authorities may soon include the IFRA standards into regulations

51

1. Meakins S. In: The Chemistry of Fragrances: From Perfumer to Consumer. 2nd ed. Cambridge, England: The Royal Society of Chemistry; 2006:184-197.

2. International Fragrance Association. http://ifraorg.org.

Adherence to IFRA Standards Is on a Voluntary Basis for Non-IFRA/RIFM Members

RIFM and IFRA industry system of standards has been successful in ensuring the safety of fragrance materials1

All IFRA-affiliated companies must comply with IFRA standards2

– Affiliated companies represent ~90% of global fragrance market

Adherence to IFRA standards is on a voluntary basis for non-IFRA/RIFM members1

JOHNSON’S® brand products include only fragrances from suppliers that abide by IFRA regulations

– Fragrance ingredients from these suppliers have undergone careful safety assessments and meet IFRA standards for safety

52

JOHNSON’S® Standards Ensure Fragrances Used Are Safe and Appropriate for Baby

53

Limits fragrance concentrations to levels appropriate for baby

The JOHNSON’S® Approach Consists of Additional Requirements Layered Onto Industry Safety Standards

Complies with IFRA standards

Applies insights from research findings on infant physiological and emotional development

Uses suppliers that design fragrances to JOHNSON’S® strict standards

Uses only fragrances with a documented safety profile and that are appropriate for baby

Tests the final product formulation, containing fragrances

54

Insights Into Baby

Fundamentals

Baby Eyes

• Eyes more easily exposed to foreign

substances (substances can be

rubbed into eyes)

Baby Respiratory System

• Cannot expel aspirated objects

• Lower respiratory system more

vulnerable to aspiration

• Lower respiratory system more

sensitive to respiratory irritants

Baby Skin

• Skin barrier is less mature

• More prone to frictional abrasion

• More permeable

• More prone to dryness

• Sensitive to sunlight

• Potential for higher exposure to

applied substances

• Thermoregulation is less mature

• Higher potential for irritation and

infection

Implication: Babies Need Products that Are Mild and Nonirritating

JOHNSON’S® Insights Into Babies’ Unique Needs Have Implications for the Design of Our Products

55

Insights into Babies’ Needs Implications for Products

Baby Bonding

Babies benefit from routines that promote relaxation and bonding. Mothers incorporate safe, mild, appropriate products into these routines

Touch and bonding play an important role in healthy emotional and social development

Baby Sleep

Sleep habits influence baby’s physical and emotional well-being

JOHNSON’S® Insights Into Babies’ Unique Needs Have Implications for the Design of Our Products

56

Considers Consumer

Preferences in Selection of Fragrances

Uses Top-Tier Suppliers and

Follows All IFRA

Regulations

Complies With All

Regional and Local

Requirements

Applies Additional

Safety Criteria

Assesses Product

Formulation Containing

Fragrance for Safety

All Suppliers Required to be

IFRA-Compliant

New Fragrances

Must Comply With EU Directive

JOHNSON’S® Monitors Consumer

Preferences

JOHNSON’S® Worldwide Fragrance Guidelines

JOHNSON’S® Uses a Multilayered System of Checks

JOHNSON’S® Approach to Fragrance Safety Is Comprehensive

Ongoing monitoring

in the marketplace

57

JOHNSON’S® Commitment to Consumer Education and Safety

JOHNSON’S® Brand is committed to providing quality personal care products that meet the needs of consumers

JOHNSON’S® Brand works to educate consumers on the selection of appropriate products

– For consumers who feel they may be allergic to products containing fragrances, JOHNSON’S® Brand offers fragrance-free products

58


The sense of smell plays an important role in infants’ physiological and emotional well-being and healthy development.

Based on JOHNSON’S® understanding of the importance of the sense of smell in baby well-being and development, fragrances are included as ingredients in JOHNSON’S® products for babies.

JOHNSON’S® Brand follows all IFRA requirements for fragrance safety in products for babies.

Fragrances are designed for JOHNSON’S® Baby products by top-tier, IFRA-compliant suppliers, based on JOHNSON’S® Brand high standards and an understanding of the special needs of babies.

Additional safety assessments conducted by JOHNSON’S® Brand on product formulations further ensures the safety of fragrances included in JOHNSON’S® products for babies.

59

Appendix

60

RIFM and IFRA Assessment Algorithms

61

Bickers DR, et al. Regul Toxicol Pharmacol. 2003;37:218-273.

RIFM Safety Assessment of Fragrance Materials: Systemic Evaluation

62


RIFM Safety Assessment of Fragrance Materials: Dermal Evaluation

63


RIFM Safety Assessment of Fragrance Materials: Environmental Evaluation

64

Fragranced Product

Individual Fragrance Molecules

x x

x

y z

X Y, Z = Other ingredients

scent 1

scent 2

scent 3

RIFM Assesses for Safety Fragrance House Designs Fragrance Formulations

JOHNSON’S® products only include fragrance molecules with demonstrated safety

JOHNSON’S® products only include fragrance formulations designed by IFRA-compliant and JOHNSON’S®

brand-compliant fragrance houses

JOHNSON’S® products undergo rigorous clinical assessments to ensure safety of all product formulations with fragrance

The JOHNSON’S® Approach to Safety Covers Each Stage of the Fragranced Product Development Process

65

Worldwide Legislation Governing Fragrance Use in Cosmetic Products

66

Tree moss

HMPCC

Oak moss

Hydroxycitronellal

Isoeugenol

Cinnamic aldehyde

Farnesol

Cinnamic alcohol

Citral

Citronellol

Geraniol

Eugenol

Coumarin

Lilial

Amyl-cinnamic alcohol

Benzyl cinnamate

Linalool

Methyl heptine carbonate

α-amyl-cinnamic aldehyde

α-hexyl-cinnamic aldehyde

Limonene

Benzyl salcylate

γ Methyl ionone

Benzyl benzoate

Benzyl alcohol

Anisyl alcohol

European Commission. http://ec.europa.eu/enterprise/sectors/cosmetics/documents/directive.

Understanding the European Union (EU) Cosmetics Directive

EU Cosmetics Directive issued in 1976 to ensure that cosmetic products marketed in EU countries meet certain standards of safety

– Lists substances which cannot be included in products

– List substances which may be contained only under certain restrictions and conditions

Directive lists 26 fragrance ingredients that may cause allergy

– Products with any listed ingredient >100 ppm in rinse-off or 10 ppm in leave-on product must list ingredient separate from fragrance on the label

JOHNSON’S® Baby respects the EU list of 26 ingredients that may cause allergy:

67

History of Fragrance

68

Development of Fragrances Before Middle Ages

3000 BC 2000 BC 1000 BC O 1000 AD

In ancient Near East, most prized incense from the fragrant cedar of Lebanon

Ancient Babylonians used resins from the pine, cypress, and fir, as well as juniper berries and gum galbanum

Maker of perfume first recorded on cuneiform tablet

Ancient Egyptian depiction of preparation of lily perfume, 2100 BC

Assyrian text documents use of ancestor of the modern rose At the time of Christ,

frankincense, myrrh, and gum labdanum (pictured) burned in the temple

First treatise on scent wrote by Theophrastus around 300 BC

In India, Gandhika (perfume dealer) sells scents for Spring festival of Holi (500 AD)

9th century Arab philosopher Yakub ibn Ishak al-Kindi writes The Book of Perfume Chemistry and Distillations

Romans make extensive use of fragrances, with special glass flasks to hold essences

History of Fragrance: The Ancient Period


69

Development of Fragrances From the Middle Ages

1000 AD 1250 AD 2000 AD 1500 AD 1750 AD

Chinese used fragrances mostly in religious ceremonies such as those at the Lama Temple (built in 1694)

The first modern perfume created in Hungary at request of Queen Elizabeth of Hungary in 1370

Knowledge of fragrance came to Europe via the Arab world during the late Middle Ages

Distillation described in the writings of Michael Savonarola of Italy in early 1400s

Adam Lonitzer publishes treatise on fragrance, Herbal, in 1577

Italian advances in fragrances taken by Catherine de Medici to France in 1570s

Eau de cologne created by the Italian Gian Paolo Feminis, early 1700s

Eugene Rimmel publishes Book of Perfumes in 1865

Advances in organic chemistry in late 1800s leads to synthetic fragrances

Persian scientist Avicenna (980-1037) discovers distillation for extraction of essential oils

History of Fragrance: The Modern Period


70

Cultural Differences in Use of Fragrance

71

1. Williams DF, ed. Chemistry and Technology of the Cosmetics and Toiletries Industries. London; Chapman and Hall: 1992. 2. UNICEF. http://www.unicef.org/sowc01/panels/panel5.htm.

Cultural Differences Dictate Perceptions and Use of Fragrances for Babies

Use of fragrances for babies varies in different parts of world1

Colognes routinely used on babies in hot climates to impart fragrance and for cooling1

– Southern Europe and Mediterranean: colognes used several times per day for cooling

In other cultures, perfumes are used routinely as part of a complex bathing routine2

– Among Baule people in Côte d’Ivoire, babies are bathed twice a day

– After each bath, baby is massaged, then creams, powders, and perfumes are applied

72

Importance of the Sense of Smell in Infant Wellness and in Healthy

Physiological and Emotional Development

73

BM, basomedial amygdaloid nucleus; Ent, entorhinal cortex; La, lateral amygdaloid nucleus; Lo, lateral olfactory tract; MRI, magnetic resonance imaging; PACL, periamygdalar claustrum; PirF, piriform frontal; PirT, piriform temporal; TU, olfactory tubercle.

MRI of Primary Olfactory Cortex

Reproduced from Zelano C, Sobel N. Neuron. 2005;48:431-454.

Zelano C, Sobel N. Neuron. 2005;48:431-454.

Unlike Other Senses, Smell Connects Directly to Central Brain Structures

Smell signals transmitted directly to central brain structures

– Other senses depend on states of attention or arousal

Evidence of the unique importance of sense of smell in humans

– Early humans may have relied on smell for identifying threats, even during sleep

74

1. Broad KD, et al. Philos Trans R Soc Lond B Biol Sci. 2006;361:2199-2214. 2. Franks KM, Isaacson JS. Neuron. 2005;47:101-114. 3. Poo C, Isaacson JS. J Neurosci. 2007;27:7553-7558.

Infants’ Sense of Smell Develops Rapidly After Birth to Adapt to the External World

Plasticity of olfactory cortex synapses is highest during months after birth

Most of human cortical brain growth occurs postpartum1

– Ensures that the brain develops in a social environment

– Promotes social skills and bonding

Experience-dependent modifications in the cortex typically occur during critical postnatal period2,3

75

4.44 4.31 4.45

5.27*

Responses were made using a 1–9 Likert scale. P<0.05 vs verbal, visual, and auditory.

Mean Responses to Memories Using Different Sensory Cues

Herz RS. Chem Senses. 2004;29:217-224.

Memories Are More Emotional When Triggered by Smell Than by Other Senses

Memories rated significantly more emotional and evocative with olfactory cues than with other sensory cues

CONCLUSION: Unique relationship exists among olfaction, memory, and emotion

76

Effect of Odor on Crying Effect of Odor on Mouthing

Mother’s scent helped infants stop crying and prepared them for feeding

*P<0.05 vs clean gown and no gown. n=44 n=44 *P<0.05 vs clean gown and no gown.

Reproduced from Sullivan RM, Toubas P. Biol Neonate. 1998;74:402-408.

Maternal Scent Has Soothing Effect and Prepares Infants for Feeding

77

Rattaz C, et al. J Dev Behav Pediatr. 2005;26:86-92.

0

5

10

15

20

MAT FVAN UFVAN

14.36 14.55

17.45

4.91 6.09

11.5 Ti

me

Cry

ing

(Sec

)

Maternal Odor

Familiar Vanilla Scent

Unfamiliar Vanilla Scent

*

*

*P<0.01, difference in crying time between heel stick period and recovery period after heel stick.

Effect of Familiar and Unfamiliar Scents on Crying Time After Heel Stick

Heel stick period

Recovery period

†Study was coordinated with routine phenylketonuria heel prick test.

Maternal Odor and Fragrance Associated With Mother Have Equally Soothing Effect on Infant

Infants who smelled a familiar odor after heel stick† cried significantly less than those who smelled an unfamiliar odor

– Results were the same for maternal odor and for a familiar fragrance

78

IFRA Certificate QRA Product Categories

79

IFRA Certificate QRA Product Categories

Category Product Types Example Product

Concentration

1 Lip products of all types (including lip creams containing sunscreen), toys, and similar products (requiring compliance with ingestion-safety considerations) Not permitted

2 Deodorant and antiperspirant products of all types (spray, stick, roll-on, underarm and body deodorants, etc), similar products 2.90%

3A Toilet waters and colognes applied to recently shaved skin and similar products that will remain on sun-exposed skin, with a 0.008% limit for methyleugenol 11.16%

3B Fine fragrances applied to recently shaved skin and similar products that will remain on sun-exposed skin, with a 0.02% limit for methyleugenol 11.16%

3C Eye products of all types (eye shadow, mascara, eyeliner, eye make-up, etc), men's facial creams and balms (including after sun and self-tanning products), baby creams, lotions, oils, and similar products that will remain on sun-exposed skin, with a 0.0004% limit for methyleugenol

11.16%

3D Tampons and similar products unlikely to remain on sun-exposed skin, with a 0.0004% limit for methyleugenol 11.16%

4A Toilet waters and colognes applied to unshaven skin, scent strips for hydro-alcoholic products, scent pads, foil packs, ingredients for perfume kits, and similar products, with a 0.008% limit for methyleugenol 35.73%

4B Fine fragrances applied to unshaven skin and similar products, with a 0.0004% limit for methyleugenol 35.73%

4C Hair styling aids, hair sprays of all types (pumps, aerosol sprays, etc), hair deodorants, body creams, oils, lotions (except baby creams, lotions, oils) and after sun and self-tanning products, fragrance compounds for cosmetic kits, foot care products, and similar products, with a 0.0004% limit for methyleugenol

35.73%

4D Fragrancing creams of all types (including baby creams, lotions, oils) and similar products, with a 0.004% limit for methyleugenol 35.73%

5 Women's facial creams (including after sun and self-tanning products), facial make-up, facial masks, hand creams, baby powders and talcs, hair permanent and other hair chemical treatments (eg, relaxers) but not hair dyes, wipes and refreshing tissues for face, neck, hands and body, and similar products

17.86%

80

IFRA Certificate QRA Product Categories (cont’d)


Concentration

6 Mouthwash, toothpaste, and other oral-care products not intended to be ingested, and similar products

Not permitted

7A Intimate wipes and baby wipes, condoms, and similar products unlikely to remain on sun-exposed skin

6.70%

7B Insect repellents intended to be applied to the skin that are likely to remain on sun-exposed skin 6.70%

8A Make-up removers of all types (not including face cleansers), powders and talcs (not including baby powders and talcs), non rinse-off hair styling aids (mousse, gels, leave-in conditioners, etc) of all types except spray-on products, nail care, and similar products that are likely to remain on sun-exposed skin

44.66%

8B Hair dyes unlikely to remain on sun-exposed skin 44.66%

9A

Conditioners (rinse-off), liquid soap, bar soap (toilet soap), body washes of all types (including baby washes), shower gels of all types, bath gels, foams, mousses, salts, oils, and other products added to bath water, shampoos of all types (including baby shampoos), face cleansers of all types (washes, gels, scrubs, etc), shaving creams of all types (stick, gels, foams, etc), depilatories, and similar products unlikely to remain on sun-exposed skin, with a 0.001% limit for methyleugenol

No restriction

9B Feminine hygiene pads and liners, toilet paper, and similar products unlikely to remain on sun-exposed skin, with a 0.001% limit for methyleugenol No restriction

9C Facial tissues, napkins, paper towels, aerosols (such as air-freshener sprays but not deodorant/antiperspirants or hair styling aid spray), and similar products that are likely to remain on sun-exposed skin

No restriction

81

IFRA Certificate QRA Product Categories (cont’d)


Concentration

10A

Hand-wash laundry detergents and fabric pretreatment products in liquid, powder, or solid bar form, fabric softeners of all types including fabric softener sheets, other household cleaning products (fabric cleaners, soft surface cleaners, carpet cleaners, etc), machine wash laundry detergents (liquids, powders, tablets, etc) including laundry bleaches, hand dishwashing detergents, hard surface cleaners of all types (bathroom and kitchen cleansers, furniture polish, etc), shampoos for pets, dry cleaning kits, and similar products

55.82%

10B Products remaining in contact with skin, including diapers and toilet seat wipes 55.82%

11A

Products leading to no skin contact or only incidental skin contact, including candles, joss sticks, incense, air fresheners and room fragrancing products of all types (plug-ins, solid substrate, membrane delivery, ambient, electrical, etc), scent pack, fragranced lamp ring, liquid refills for air fresheners (cartridge systems), insecticides (mosquito coil, paper, electrical, etc), toilet blocks, floor wax, plastic articles (excluding toys), fuels, paints, and similar products

No restriction

11B

Products leading to only incidental skin contact but previously considered by IFRA as not "nonskin-contact products,” including liquid refills for air fresheners (noncartridge systems), potpourri, fragrancing sachets, reed diffusers, scratch and sniff (sampling technology), shoe polishes, carpet powders, treated textiles (eg, starch sprays, fabric deodorizers, pre-perfumed fabrics), machine dishwashing detergents, machine dishwashing deodorizers, deodorizers/maskers not intended for skin contact (eg, fabric drying machine deodorizers), perfumed distilled water for addition to steam irons, animal sprays, cat litter, and similar products

No restriction

82

JOHNSON’S® Approach to Fragrance Safety

83

Option A) In the composition of the fragrance, any of the fragrance components listed in the EU Cosmetics Directive Annex III, Part I must not be directly added and must be <50 ppm from all indirect sources in the finished fragrance. (50 ppm was calculated to provide a working limit. If a fragrance is in a product at 1%, the ppm of any one component will not exceed 0.5 ppm.) In addition, camphor, menthol, thyme oil, and eucalyptus may not be used as fragrance components under this option. Option B) Any of the fragrance components listed in the EU Cosmetics Directive Annex III, Part I must comply with the restrictions for leave-on (<10 ppm) and rinse-off (<100 ppm) products therein to avoid the labeling requirement. The limits are calculated on the total weight of the product. Option C) Any fragrance component identified in the EU Cosmetics Directive Annex III, Part I may be used above the labeling threshold, except for the ones prohibited below. Under EU regulations, labeling for cosmetics will be required for any component that exceeds the labeling threshold.

All new fragrances used by JOHNSON’S® brand must be IFRA-compliant and must satisfy the following additional requirements by product category:

Option A applies to JOHNSON’S® Baby Products

JOHNSON’S® Brand Complies with IFRA Standards and Imposes Worldwide Ingredient Requirements in Products and Fragrances

role of fragrances in johnson’s® aby products · 2 objectives define and explain fragrances...

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