"Is excessive
regulation destroying
the perfumery art?"
by Tony Burfield
Cropwatch
www.cropwatch.org
Logo: Juniperus procera Hochst. ex Endl.
(Kenyan Cedarwood): Over-Exploited to Near
Extinction by the E.O. Trade.
Who are Cropwatch?

A loosely based, non-financed, independent watchdog to the aroma & natural products trade. In
existence approx 6-7 years.

Best known for its pro-active campaigning activities

No formal membership; produces an occasional
Cropwatch Newsletter which reaches some 40,000
people.

Provides free information on natural aromatics on its
website www.cropwatch.org and free advice to
enquirers.
on natural aromatics, data-bases on threatened
aromatic species & bio-piracy, long-term opposition
to the 26 allergens legislation, & to the QRA (which
the SCCP has also criticised in SCCP/1153/08).
Part I – Perceived Problems with
Fragrance Safety Legislation
& Safety ‘Experts’.
Safety Issues in the Aroma Business.

Fragrance customers usually insist on adherence to all
existing H&S guidelines (both official & voluntary)
because of the prevailing fear-culture, and possible
media exposure regarding potential adverse effects to
end-users from single ‘hazardous’ fragrance
ingredients.

EU Regulators have no capability of gauging the socioeconomic effects of their policies. Banning or
restricting natural aromatic materials often has severe
economic consequences for natural aromatic
producers and dependent communities in developing
countries. Disastrous EU legislation is (sometimes)
followed by an impact assessment and (then possibly)
corrective action – but by then its often too late to save
any affected SME’s (e.g. the effect of the BPD on
Europe’s natural biocidal product manufacturers).

Knowledgeable whistle-blowers revealing questionable
trade practices are shunned by the trade (for example,
as detailed in the letters of the late Stephan Arctander).
Safety Issues in the Aroma Business cont’d.

So many SME’s (candle-makers / soap-makers/
incense traders / pot pourri makers / hand-made
cosmetics makers / general cleaning product makers
/ natural perfumers / aromatherapists etc.) cannot
afford IFRA / RIFM’s annual fees, & so are locked
out of access to a lot of detailed safety data.

Perfume manufacturing orgs. require the implicit
adherence of their members to IFRA Standards &
CoP [note: these are not legal requirements, with the
exception of Eco-label fragrances]. However many
traditional perfumes types, as well as natural,
organic & functional perfumes are almost impossible
to construct under existing IFRA regulations.

Safety data is often generated by the major aroma
corporates in an atmosphere of secrecy & may have
private ownership issues attached; data can be
difficult to locate, & expensive or virtually impossible
for the general public to obtain. There is also a lack
of transparency by regulatory professionals.
Healthy factory environments:
at least, nobody ever caught a cold!
The ‘Zero Risk Mindset’.


EU Regulators apply - (or appear to have been
pressurised into, by ‘invisible’ lobbyists) a
disproportionate & excessive degree of regulation wrt
aromatic ingredients, which appears to be an attempt
to construct a clean, risk-free and largely syntheticbased world of their own. That is not the world that
most of us wish to inhabit, and Cropwatch believes
that many will ignore any restrictions which deny us
the use of those familiar natural materials which we
associate with our lives, our heritage & our traditions.
“..a society that does not try to shape its future ends
up being dictated to by its own anxieties.”
- Hunt (2004)
So How Dangerous is it to go Outside…?

The green leaves of trees & plants continuously emit & -pinenes, limonene etc. Shenck (1979) estimated
that 438 million tons of monoterpenes* evaporate into
the air continually from biological materials [*natural
monoterpenes that are designated ‘dangerous for the
environment’’]. It has been calculated that one European
forest puts more chemicals into the environment that the
whole EU chemical industry.

Emitted leaf volatiles also react with ozone to form
irritating / sensitising terpene epoxides. Some US
fragranced home-care products containing limonene are
labelled (paraphrasing): do not use if smog outside !

Tree leaf volatiles also react with nitrogen oxides from
combustion engine emissions causing chemical smogs.
Academics at Lancaster University (2002) recommended
that UK councils modify the planting of certain VOC
emitting trees (maple trees: good; oaks & poplars: bad!)
(not, you will notice, take any steps to stop cars emitting
nitrogen oxides).
Nature: Presents More Hazards than
Using Fragranced Products?

Inhalation of fern spores poses a cancer risk to
countryside visitors / dwellers, & the spores are also a
risk to the safety of potable water supplies (Calif. Prop
65).

Unregulated nuisance farm crops such as mustard seedrape (flowers & roots) emit allyl isocyanate, benzyl
cyanide etc. into the air & soil. Aerial dispersion causes
respiratory distress / allergy to many in vicinity (see
Rapeseed report: Cropwatch Files).

This is not to mention the unregulated intake of natural
carcinogens, mutagens, toxins etc. consumed in food &
spices, & beverages (e.g. methyl eugenol from pesto,
safrole from nutmeg, and the CMR1 substance ethanol).
Crop of Unregulated Allyl
Isocyanate & Benzyl Cyanide
Emitters (Brassica napus L. ssp.
oleifera).
Forest of Unregulated - & -Pinene Emitters
(Pinus sp.), Finland, near Local Aquifer! (can
you spot the Daphnia?)
Unregulated Phenylacetaldehyde Emitters Lotus
corniculatus L. growing in the Shetlands!
Unregulated Wild-Flower
Coumarin Source
(Melilotus officinalis L.).
Unregulated Plateful of Suspected
Rodent Carcinogen posing as Foodstuff.
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REACH.
Industry is seen as a cash-cow by the EU H&S
Commission. REACH registration costs will
potentially ruin all but the largest aroma concerns, in
spite of concessions for SME’s. The aroma industry
magnates therefore divisively support the REACH
regulations as a means of eliminating competition.
The ECHA has created an unmonitored situation
under REACH (e.g. for lead registrants & for SIEFS
etc.) where bullying and mafia-like activity by large
aroma industry corporates has gone unrestricted.
REACH will severely reduce the available portfolio of
fragrance ingredients – Western companies will only
be able to make ‘Mickey Mouse’ perfumes.
REACH has already driven the focus of activity of
leading trans-international aroma companies out of
Europe.
Leading toxicologists are opposed to REACH (see
next slide)
The Basis of REACH challenged



The idea that the toxic effects of a chemical show a
dose-dependent linear relationship ending at a
threshold level is now challenged: at low levels
adaptive, non-adverse or even beneficial effects
occur (hormesis), and have been shown for >6,000
chemicals (Calabrese 2004).
This raises a ‘serious misreading of the term toxic’
charge for the EPA, and for the ECHA over the
REACH legislation, and suggests that the 50-100
million Euros spent on the exercise is wasted, and
will not save a single life.
The above reference to the EPA needs to be seen as
what appears to be a gagging order, mentioned a
document prepared by the EPA in 2004, which states
that the purpose of a risk assessment is to identify
risk (harm, adverse effect etc.), effects that appear to
be adaptive, non-adverse or beneficial may not be
mentioned. - through Calabrese (2007) ”Belle Newsletter:
Introduction. “ Human & Experimental Toxicology 26, 845.
The importance of natural
aromatic ingredients.
Naturals breathe life into an otherwise simple blend of
chemicals, adding depth and sophistication - whether
floral absolutes, woody materials or citrus oils are
employed (many of these ingredients will disappear
under REACH).
 Whole fragrance styles / families would not exist without
naturals – for example, Eau de Colognes, Eau Fraiches.
 Many landmark fragrances & fragrance styles owe their
conception to key natural materials e.g. the chypre style
of Mitsouko & Miss Dior, which were based on accords
of oakmoss, patchouli oil and labdanum together with
bergamot oil.
 Many essential oils lend an incomparable radiant
freshness to fragrances e.g. lime, lavender & petitgrain.
It is hard to imagine an impressive masculine fine
fragrance which merely relies on synthetic materials for
its freshness.

A Timid Industry.


Cosmetic / biocidal / detergent & cleaning ingredient
restrictions & regulation proceed with little effective
trade questioning or objection in the EU, leading to
questions about why industry is so timid (see
Durodie 2004).
But ‘the worm is turning’. In the US, cosmeticsbased SME’s are grouping together to prevent
financially discriminating legislation acting against
them – for example over the crippling fees & costs
involved with compliance to the FDA Globalisation
Act HR-759, 2009). The Colorado Safe Personal
Products Act HB-1248 which proposed zero
tolerance for many ‘hazardous’ single cosmetic
ingredients (& so was potentially even more extreme
than existing European legislation) failed in
committee (01.03.2010) due to pressure from SME’s.
In S.E. Asia, producers of natural aromatic materials
& cosmetics are just starting (Feb 2010) to form antiregulation groups to protect their livelihoods.
Shortcomings of the EU Cosmetic
Commission’s H&S Policies.

The EU Cosmetics Commissions’ CoP refuses to define
‘safety’, there is no individual ingredient risk
quantification, it does not consider ingredient risk /
benefit considerations (except for preservatives), it does
not allow in-use considerations, & it does not allow for
end-consumer adverse reaction statistics to affect safety
policy - as apparently this is not ‘bona fide’ evidence
(Daskaleros 2007).

This ‘risk-only’ chemophobic scenario leads to a state of
toxicological imperialism, where over-precaution &
scare-mongering are de rigueur, and where
pharmaceutical & chemical company lobbying
disadvantages competitive natural products. Worrying
situations of vested interest (e.g. in the SCC(S)(P))
remain unaddressed. Europe has become a hostile
environment for perfumery; many concerns have relocated outside the EU.
A Lack of Cross-Disciplinary Expertise..


EU Cosmetic Comm. staff admitted to Cropwatch
(Brussels 2007) they were unable to find the
services of a botanical expert, and the SCCP had no
literature search ability until 2007 (& so previously
could not properly independently review the
evidence presented to them). Now a pool of 160
’experts’ is supposedly to be made available to
Brussels staff (but no word on any botanists!).
The previous safety assessments of many / most
natural fragrance ingredients by RIFM have
proceeded via industrially donated materials which
have not been botanically identified at source by an
expert, were not batch-tracked and not proven as
100% derived from the named botanical. The lack of
forensic and taxonomic application has led
Cropwatch to describe a number of IFRA Standards
as non-robust, where botanical identifications (as
published) are either incorrect, incomplete or based
on false assumptions of ingredient purity e.g. for
opoponax (see Cropwatch Files - Opoponax).
..and a Lack of Ecological Awareness..



The industrial over-exploitation of many natural
aromatic species by the Cosmetics &
Pharmaceutical industries remains virtually
unchecked – by the time a CITES listing or an IUCN
Red Listing is in place, it is often too late to save the
species under threat, or the full compliment of its’
genetic diversity.
For example while IFRA pondered a new Standard
for styrax qualities, less than 15 hectares of Asian
styrax trees remained unlogged in Turkey.
Commodities from rare or threatened species
include: agarwood oil, sandalwood oil East Indian,
sandalwood oil East African, rosewood oil, Cedrela
odorata oil, guaiacwood oil, copaiba balsam, gurjun
balsam, candeia plant spp., costus qualities,
Parmelia (fragrant lichen) qualities, some
frankincense yielding spp. e.g. Boswellia papyrifera,
chaulmoogra oil and many others (see Cropwatch
data-base on Threatened Aromatic Species).
Media Bad Science on
Naturals – an Example.

Gynecomastia in 3 pre-pubertal boys, allegedly
caused by using lavender/TTO-containing
cosmetics / personal care products (Henley et
al. 2007), received much newspaper coverage
in 2007-8. The New England Journal of
Medicine which ran the article, had previously
announced a policy change, as it could not find
independent experts for peer reviewing, who
had not been paid off in some way by industry
(Newman 2002). A pity, since refutation of the
robustness of science behind the alleged
gynecomastia-lavender/TTO link followed [e.g.
by Nielson (2008) & Lawrence (2007) amongst
others], but of course, received no attention from
the popular media.
Bad Science on Naturals in PeerReviewed Journals – An Example.
According to Frosch, White et al. (2002):
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patchouli oil contains cinnamic aldehyde,
benzaldehyde & eugenol!
Atlas cedarwood oil contains alpha-ionone!
sandalwood oil contains geraniol & citronellol!
the main components of spearmint oil are limonene,
3-octanol, menthone and dihydrocarvone (but no
mention of the major constituent: carvone!)
Ref: Frosch P.J., Johansen J.D., Menné T., Pirker C.,
Rastogi S.C., Andersen K.E., Bruze M., Goosens A.,
Lepitoittevin J.P. & White I.R. (2002) “Further important
sensitisers in patients sensitive to fragrances II Reactivity to essential oils.” Contact Dermatitis 47, 279287.
Part 2. The Mis-regulation
of Natural Ingredients – some
Examples
Destroying the very foundations
of perfumery.



The restriction/banning of key fragrance ingredients on
dubious / over-precautionary safety grounds, can easily
compromise the founding elements of the traditional
perfumery art. For instance, the crucially important
fougère perfumery accord consists of a combination of
bergamot, coumarin & oakmoss.
Bergamot oil usage is under threat from potential EU
legislation because of its allegedly photo-toxic
furocoumarin (FC) content (see flawed SCCP Opinion
0942/05, then compare with the Cropwatch FC database).
Oakmoss was originally proposed to be restricted as a
sensitiser under SCCP/1131/07, limiting the potent
sensitisers atranol & chloroatranol to 2ppm in product.
Cropwatch (2009) described this Opinion as unsafe from
a failure to consider all the published evidence (which it
has subsequently made publicly available). EU policy on
oakmoss / treemoss has since been modified.
Public Objections to ‘Safe’
Reformulations of Classic Perfumes.

Reformulations of classic perfumes, carried out
in order to conform to modern regulatory
requirements, have led to disappointment and
bitterness amongst their long-term devotees,
whose historical memories and emotional
attachments are evoked by the odour profiles of
particular fragrances, as part of their rightful
cultural inheritance. Many fragrance houses
seem in-denial about the whole subject, but
Turin (2007) has remarked on customer anger
generated during the Guerlain Mitsouko
reformulation debacle. Internet discussions on a
wider range of classic perfumes whose
character has been allegedly mutilated by
reformulation are available (for example see
Perfume of Life Forum Jan 2007)…
Natural Ingredient Usage Declines.

The usage of naturals has declined in perfumery
from downward pressure on ingredient costs
(synthetics are comparatively cheaper), erratic
supply (climatic & geophysical events; political
events; demand pressures) & from stability &
compositional issues.

Under existing EU H&S policy, natural complex
substances are treated as a collection of
individual composite chemicals. The vast
majority of essential oils, absolutes & resinoids
contain several of the 26 named allergens,
which have to be labelled under EU Directive
2003/15/EC (now under review). The desire by
cosmetic manufacturers to avoid excessive
product labelling has previously lead to some
decline in the overall usage of essential oils.
Naturals Usage Declines cont’d.

Under CHIP / EU DPD & DSD (now under the CLP
1272/2008/EC), R50/53 environmental labelling (dead fish /
dead tree symbols) and R65 labelling have had a serious
impact on usage of citrus oils & their terpenes. Citrus oils
have been traditionally employed in many types of
perfumes for household & air care products due to their
diffusion, lift & fresh character, but perfumers now find it
difficult to use them for the reasons above. Ditto for pine
needle oils.
 Cinnamon leaf & clove oils were used in pot pourris &
candles, but R43 issues with cinnamic aldehyde &
eugenol contents etc. mean that their use is restricted.
 Minor oils that IFRA has banned / restricted on predictive
toxicological grounds, but has no funds to practically
investigate – melissa, santolina, boldo etc. NB Cropwatch
recently published the Robertet toxicological evidence on
melissa oil showing the original IFRA ban was unjustified
 Natural products needing expert botanical identification
& chemical analysis for QRA studies, are/were not
supported (read: can’t afford to support) by IFRA–
opoponax, styrax..
The ‘Weak Animal Carcinogens’ Issue.

The EU classification of methyl eugenol as a suspected
rodent carcinogen & mutagen, and safrole as a
hepatocarcinogen, together with corresponding IFRA
restrictions, has led to a great reduction in the use of
those natural materials which contain them, such as the
methyl eugenol-containing spice oils: clove bud, pimento
leaf & pimento berry. The use of rose oil has been
similarly affected - it is now virtually impossible to create
a 100% natural rose fragrance which complies to IFRA
guidelines, formulated with >1% rose oil. Use of
cinnamon leaf & nutmeg oils too, has also been curtailed
by the safrole classification, as has the use of basil &
tarragon oils containing estragole (weak carcinogen,
weak mutagen).

Such limitations have had significant effects on fragrance
styles entering the market place: traditional aromatic
masculine fougères and rich spicy notes are very difficult
to achieve at so-called ‘safe’ levels.
Some Inconvenient Classifications.

Safrole: carcinogen cat. 3 mutagen cat. 2 (EFFA CoP
2009). Occurs in sassafras, nutmeg, mace, star anise &
cinnamon leaf oils.
 Methyl chavicol: Possible weak genotoxic
hepatocarcinogen (SCF 2001). Occurs in star anise,
exotic basil, fennel, tarragon oils.
 Methyl eugenol: Possible carcinogen (US). Calif. Prop.
65 carcinogen. Occurs in rose, basil, bay WI, cananga,
citronella Sri Lanka, pimento, lovage & betel oils etc.
Human exposure levels normally several magnitudes
below bioassay levels for rats, mice; relevance of rodent
data questioned (Robison & Barr 2006).
 Ethanol: CMR cat 1. Cosmetic manufacturers are
currently withdrawing ethanol from mouthwash
formulations. Indispensable ingredient to cosmetics
trade.
Legislation-Compliant Ingredients?

Cropwatch has a large A-Z data-base of articles on
the various furocoumarin (FC) contents of natural
products following FC phototoxicity issues (under
SCCP/0942/05 etc.). Companies like Treatt, Capua
etc. now market a range of FC-free citrus oils, but
small traditional producers of citrus oils are
potentially disadvantaged without huge technology
investments. And for what reason? The safety case
for reducing FC’ s to the minute levels the EU
proposed in cosmetic products is not robust, and
other commonly used cosmetic ingredients also
show photo-toxic effects.
 To date, safrole-free nutmeg qualities, methyl
eugenol-free rose oil, IFRA compliant oakmoss
qualities, furanocoumarin-free bergamot oil etc. etc.
have all proven to be more-easy-to-adulterate, pale
olfactory shadows of traditionally produced natural
products. This reduction in ingredient quality
compromises the art of the possible in perfumery
practice.
‘Allergic’ Fragrance Ingredients.
SCCNFP in Opinion SCCNFP/0017/98 & 0329/00 identified a
number of fragrance chemicals (16 of which occur in natural
products) associated with a labelling obligation for allergens
where conc. in the final product is <0.01% in products rinsed
off the skin products or <0.001% in leave-on products. This
was incorporated into Council Directive 2003/15/EC. The
basis for the inclusion of these chemicals as allergens has
never been explained by the SCCP (Storrs 2007). The
chairman of the SCCP (Ian White) has co-authored a number
of research papers on alleged allergens, & cannot be said to
be a disinterested party.
 Independent papers / peer-reviews (e.g. those by
Schnuch, Floc’h, Vocanson, several by Hostynek & Maibach)
have indicated that there is no robust clinical or experimental
evidence to support many of these 26 ingredients as
allergens. Schnuch (2008) asked the EU to rethink their
policy.
 Hostynek & Maibach’s (2008) detailed article on “Allergic
Contact Dermatitis to Linalool: Allergen Status Disqualified”
has appeared in a third consecutive journal/trade magazine.

Allergic Fragrance Ingredients II.

A request for an updated scientific opinion on the
labelling of 26 fragrance substances which were
introduced into Annex III of the Cosmetics Directive
by 2003/15/EC was made by the EU Commission of
the SCCP, politically passed off as ‘a spin-off from
the public consultation (Nov 2006) on the
Commission proposal of regulation of some
fragrance substances’.

"Scientific information of general and specific nature
has been submitted to DG-ENTR. in order to ask the
SCCP for a revision of the 26 fragrances with respect
to further restrictions and possible even delisting.”

“At that time there were not sufficient scientific data
to allow for determination of dose response
relationships and/or thresholds for these allergens”.
- Cropwatch comments: if this is manifestly correct,
why did they go ahead with the legislation?
Allergic Fragrance Ingredients
III

The older Opinion SCCNFP/0017/98, divided
allergens as most frequently listed (list A)
and infrequently listed (list B), but the recent
Brussels request to the SCCP (see previous
slide) makes no reference to the work of
Schnuch et al. (2007), who called for a
slightly different list of substances to be
reviewed as allergens, on the basis of his
published work indicating there were no
safety concerns to consumers for a number
of these SCCP allergens.
The Tea Tree Oil (TTO) Debacle

TTO is in a Catch-22 situation. It is universally
acknowledged by microbiologists as a useful biocide
except by the EU Biocides Commission. Therefore,
apparently, TTO in EU cosmetic products ‘does not have
a cosmetic purpose’ (SCCP/1155/08).
 Also according to SCCP/1155/08, diluted TTO might be
unstable in cosmetic formulations, skin & eye irritation
not assessed by adequate methods. The SCCP
identified data-gaps relating to subchronic toxicity,
percutaneous absorption, genotoxicity / carcinogenicity &
reproductive toxicity.
 The ATTIA (& RIRDC) made the big mistake of
submitting a safety dossier to the SCCP on these
shortcomings, at a cost of £200,000 Australian, thus
creating a precedent for the whole essential oils industry.
The SCCP took nearly 2 years to evaluate their data,
and still were not satisfied.
 Adverse end-user reactions from sales of tens of millions
of small bottles of TTO by major distributors runs at <
0.0015% (Cropwatch, unpublished data).
Vanillin

Under IFRA’s 44th Amendment, vanillin was at first restricted on
alleged QRA sensitisation grounds, but this restriction is
currently suspended (this dithering costing industry hundreds
of thousands of Euros in reformulation, ingredient stock
adjustment, costs of buying in substitution stock and relabelling). Current vanillin consumption is about 6,000t/y.

Vanillin has been the foundation of the oriental fragrance family
formed from accords of vanillin, balsams, spices, patchouli,
woods, salicylates and citrus oils. Jicky, created in 1889 by
Guerlain was the first major oriental fragrance founded on this
accord.

In the early to mid 1990s a major vanillic trend was founded on
an overdose of vanillin and vanilla. Beginning with Vanilla
Fields (Coty 1993), a host of sweet vanillic floral and vanillic
floriental fragrances were launched e.g. Tocade (Rochas 1994),
Loulou Blue (Cacherel 1995), Le Male (J. P. Gautier 1995), Allure
(Chanel 1996), Ghost (2000). This trend of the 1990s has lead to
a general sweetening of fragrance styles, (and consequently a
generally higher use of vanillin), which is apparent today in the
myriad of oriental masculine styles (e.g. 212 Sexy for Men 2006)
and fruity floral feminine types and fruity florientals (e.g.
Delicious Night DKNY 2007).
Vanillin II

Evidence for the alleged very weak sensitising activity of
vanillin (according to IFRA) rests on 3 pieces of evidence,
2 of which are hardly new but are unavailable to the
general public:
Basketter D.A., Wright Z.M., Warbrick E.V., Dearman R.J., Kimber I., Ryan C.A.,
Gerberick, G.F., White I.R. (2001). “Human potency predictions for aldehydes
using the local lymph node assay.” Contact Dermatitis, 45, 89-94.
RIFM (Research Institute for Fragrance Materials, Inc.), 1970. Maximization
study with vanillin. RIFM report number 1760, October 7. (RIFM, Woodcliff Lake,
NJ, USA).
RIFM (Research Institute for Fragrance Materials, Inc.), 2009. Human repeated
insult patch test. DRAFT REPORT. (RIFM, Woodcliff Lake, NJ, USA).

Opposing evidence to the sensitising potential of
vanillin was listed in Cropwatch Newsletter 15 – for
example >99% vanillin ex lignin has been found nonsensitising. But it is likely that this major fragrance
ingredient will yet suffer severe usage restrictions
on dubious QRA testing grounds.
Coumarin I
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
Coumarin is regulated by EU Directive
2003/15/EC such that coumarin requires
labelling as a sensitiser if present at
concentrations of >10ppm in fragranced leaveon products, or >100 ppm in fragranced
products washed off the skin.
SCCP Opinion /0935/05 on 99.9% pure coumarin,
shows the expert committee had misunderstood
the data, incorrectly concluding that pure
coumarin is a sensitiser - Schnuch (2004), Floc’h
et al (2002), Vocanson et al (2006 & 2007) and
many others have opposing views. Cropwatch’s
submission to DG-Ent. on coumarin was never
acknowledged.
Minor impurities in some commercial grades of
synthetic coumarin used for allergy testing
(dihydrocoumarin; 6-chlorocoumarin etc.) may
however be sensitising.
Coumarin II.
Only 1 well-documented clinically relevant case of allergy
to coumarin has ever been reported (Mutterer et al. 1999).
Low numbers of clinically relevant cases exist for many
other alleged allergens listed under EU Directive
2003/15/EC. The legislation clearly lacks proportionality.

EFSA (2004) concluded that coumarin is non-genotoxic.
Any human carcinogenicity issues may only be relevant
to very small sub-section of human population (Lake
1999).

Federal Institute for Risk Assessment (BfR) had to be
publicly corrected in 2007 on alleged risks with coumarin
toxicity from cosmetics. The BfR had wrongly maintained
that the TDI (0.1mg/d) for coumarin could be exceeded by
the normal application of cosmetics. Commentators are
on record as saying that Prof. Hensel has, additionally,
not understood species differences relevant to coumarin
metabolism.
Other Fragrance Ingredients with
Questionable Restrictions.

Benzaldehyde (used for almond & cherry notes);
tagetes oils & absolutes; oakmoss & treemoss
qualities; FC-containing citrus oils; opoponax &
styrax qualities; jasmine absolute; santolina,
boldo & melissa oils; oils of the Pinaceae.

All of these and many others have been
discussed by Cropwatch (see website), and
many are the subject on on-going investigations
to reverse the hasty & over-precautionary
limitations imposed.
References.
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Acronyms.
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ATTIA – Australian Tea Tree Industries Association
BfR - Federal Institute for Risk Assessment
BPD – Biocidal Products Directive
DG-ENT - Directorate General (Branch of European Commission responsible for Industry)
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CoP – Code of Practice
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E.O. – Essential Oil
ECHA - European Flavour & Fragrance Association
EFSA - European Flavour & Fragrance Association
FC – FuroCoumarin
H&S – Health & Safety
IFRA - International Fragrance Association
QRA - Quantitative Risk Assessment
REACH - Registration, Evaluation, Authorisation and Restriction of Chemicals
RIFM - Research Institute for Fragrance Materials
RIRDC – Rural Industries Research & Development Corporation (Australian Govt).
SCCNFP - Scientific Committee on Cosmetic Products and Non-Food Products
SCCP - Scientific Committee on Consumer Products
SCF – Scientific Committee on Food
SME – Small to Medium sized Enterprise
TDI - Tolerable Daily Intake
TTO – Tea Tree Oil
VOC – volatile organic carbons