Transcript Quote: - Natural Ingredient

“Over-regulation is Destroying
Natural Aromatics.”
- Tony Burfield,
Co-founder, Cropwatch.
Presented at the 38th ISEO
Conference, Graz, Austria
on Wed 12th Sept 2007
Cropwatch
 Independent
Watchdog for the Aroma
Industry.
 Non-financed
 No
formal membership
 Newsletter
subscriber list on website
www.cropwatch.org
No worries - Lavender cutting in UK
Quote:
Nietzsche: "Madness is
rare in individuals, but
common in parties,
groups & organisations.”
Nonsensical Over-Regulation of
Aromatics

Why has it occurred ?

Why do we put up with it ?

Has anybody objected & what has happened ?

Re: status quo: who’s interests does it suit ?

What can we do about it?
Hyperbureaucratic
Technocracy

Perfumery/essential oils regulation hi-jacked by
career toxicologists – EU lawyer alliance

Flurry of over-restrictive measures for aroma
ingredients based on ‘Precautionary Principle’

No risk-benefit analysis; No risk quantification

No typical ‘in-use’ considerations

No end-user adverse effects evidence allowed
by EU Cosmetics Commission
Toxicological Imperialism

Impenetrable ‘big industry toxicology - EU lawyer
culture’ rules the cosmetics/toiletries/HP area

Selective toxicological evidence is forwarded to
‘expert’ committees - such as SCCP

Adherence to IFRA/EFFA CoP’s is condition of
joining some perfumery organisations (!)

Individuals/groups with contrary views on safety
are ignored, or deliberately kept ‘out of the loop’
Over-Regulation

‘Culture of fear’ amongst perfume-buyers arising from
prospect of ingredient safety scares in the media

Therefore perfume-buyers require supplier’s guaranteed
adherence to IFRA & EFFA CoP’s, EU Directives etc.

Strict adherence to ingredient restrictions destroys
perfumery excellence: creates synthetic junk perfume
scenario.

The more restrictive the legislation, the lower the
volume of natural products used.
Culture of ‘chemophobia’
 Career
toxicologists/dermatologists have
created ‘scare-mongering’ culture
 EU
Cosm. Comm. have responded with
politically-motivated safety program
 So
Europe has become a hostile
environment for Aroma trade & many
companies have relocated outside Europe
Over-regulation
Essential oils need to conform to/are regulated by:

National Pharmacopoeias, ISO stds, EOA stds, IFRA
Stds, EFFA CoP’s, FEMA/GRAS, EU Cosm. Directive
 If Biocides, under 98/8/EC. If cosmetics 76/768/EEC.
 If flavourings, under 88/388/EEC, if foodstuffs 178/200
EC, if feedstuffs under 70 /524 EEC .
 If Allergic data, to Directive 2003/15/EC amending
76/768/EEC
 If Pharmaceuticals 83/2001/EC; Trad Meds 24/2004/EC



GMO declaration under EC 1829/2003 & EC 1830/2003
Heavy metals, dioxins, PCB’s, pesticides, 3-MCPD etc.
Labelling & packaging regulations, transport/shipping.
“26 Allergens” Debacle

Some of 26 not allergenic e.g. coumarin

Some of 26 not allergenic enough to require legislation
e.g. citronellol, geraniol, anisyl alcohol

Any allergenic effects in CBS’s still to be evaluated for
effects from oxidisable ingredients e.g. linalool, geraniol

Contrary evidence not properly considered

New investigation of SCCP Opinions required under by
independent body – some SCCP committee members
are not disinterested parties.
Over-Regulation: Environmental
classification

Ecotoxicity
Aquatic environment:
• vertebrates
– fish
• invertebrates – daphnia
• plants
– algae
Terrestrial environment - no detailed criteria
• mobility
• persistence and degradability
– COD/BOD
– Biodegradation studies
• bioaccumulation
– log Pow
Natural product use perceived
to decline in cosmetics ?
“...essential oils (which currently
appear to be used more in
aromatherapy than in
perfumery)...”
Anton C. de Groot, Peter J. Frosch (1997)
"Adverse reactions to fragrances. A clinical
review." Contact Dermatitis 36 (2), 57–86.
Essential Oil Organisations…
 Don’t
fight the science behind the
progressive regulatory restrictions
 Charge
 Are
 Are
$$$’s for membership
a closed-shop
over-deferential to regulators, & sadly,
are largely ineffective
(A Very) Precautionary Principle

Not tied into actual risk quantification

Tied into NOEL of pure ingredient + safety factor

Matrix effects not considered

Usage conditions not considered

Risk-benefit analysis not performed

End-user adverse effect data not allowable as
evidence (stated EU policy)
(A Very) Precautionary Principle






Has frozen EU natural biocides industry & halted
innovation.
Only 2 natural biocides remain supported in 2nd
Phase of Review Process of Active Substances
in the BPD of the EU (garlic oil & margosa oil)
Industry too small to support safety studies
USA does not restrict natural biocides
Other govts consider essential oils as ‘of low
toxicological safety concern’
Natural biocides industry has no trade assocn –
so regulatory stalemate!
Quote:
Fenn R.S. (2005) “Europe’s
obsession with the
precautionary principle is
stultifying our creativity”
Perfumer & Flavorist vol 30 (Jan/Feb
2005) p 25.
Quote:
 Frank
Kafka:
“…it must be suspected that,
paradoxically, that these (scientific)
fundamentalists have contributed in
creating or preserving the most fearful
& oppressive fictions.”
Quote: Cropwatch (2007):
 The
EU Commission should require a
precautionary approach which highlights
the areas of uncertainty and absence of
information, which will then provide a
much better basis for decisions about
whether to proceed. At present pressure to
proceed is unrelenting even in absence of
comprehensive toxicological data e.g. over
the intention to restrict FCF’s in cosmetics.
Need for EU Fragrance
Commission

Fragrance is used in other areas than cosmetics
e.g. household products, aerosols,
environmental fragrancing, candles & incense,
reodourants etc.

Perfume is about art, heritage & culture. EU
Cosm. Directives have socio-economic &
ecological fall-out effects. EU Cosm. Comm.
refuses all above responsibilities, apart from
(politically compliant) safety aspects.
Natural Ingredient Restrictions
 EU
Cosm. Directives
 EFFA CoP
 40th-42nd
IFRA Amendment & IFRA Stds
 Dangerous
substances Regs (CHIP in
UK); Dangerous Preparations Directive
 REACH
40th Amendment to IFRA CoP

Has ruined spontaneous creativity in perfumery

Perfume creation now merely a software
exercise

Excessive red-tape mitigates against SME’s

Back-lash amongst natural perfumers, crafters,
soap-makers (>920 signed Cropwatch petition
against 40th Amendment which IFRA ignored).
IFRA Standards
 Progressively
reduce use of naturals in
fragrance formulations. Contrarily,
consumers want perfumes with
guaranteed naturals content!
 Minor
ingredient safety studies abandoned
due to economic considerations
 Major
worries now over future situation
regarding ethanol, citrus oils etc.
Examples of Restriction.
Oakmoss – foundation of Coty’s Chypre,
Guerlain’s Mitsouko, Dior’s Miss Dior.
 Styrax – once important perfumery ingredient –
now only exists as flabby neutralised products.
 Minor oils banned IFRA (lack of funds to
investigate): Melissa, Santolina
 Cinnamon leaf oil (& Clove oil) – used in
potpourris, candles but R43 issues mean
replacement with methyl cinnamic ald. etc.

Examples of Restriction (2).

No one wants environmental labelling – R50/53
dead fish/dead tree symbol on product.

(Cheap) Citrus oils have traditionally been used
in many types of air fresheners, particularly
wicks & gels, for their diffusion, lift & character
but perfumers now find it difficult to use them at
useful levels because of R50/53 labelling. Ditto
for pine oils.
Examples of Restriction (3)

FCF’s in Citrus oils. Citrus oils occupy a unique
place in perfumery esp. bergamot oil

Restriction of  FCF’s to 1 ppm in finished
cosmetics will cause chaos

SME’s in S. America, Cuba, Africa etc. with no
FCF reducing technology liable to be more
affected than big concerns elsewhere
Examples of Restriction (4)

Methyleugenol (ME) IFRA limits:
Fine fragrance: 0.02% Eau de toilette: 0.008%
Fragrancing cream: 0.004% Other leave on: 0.0004%
Rinse-off: 0.001% Non skin: 0.02% - conc in fragrance
compound
Other non cosmetic products not covered above: 0.001%

Many natural products contain ME from pimento leaf
oil to nutmeg oil restricting their use. Contrary
evidence on ME carcinogenicity never considered,
new research not evaluated, review long overdue.
Examples of over-exploitation

Sandalwood. Forests all but disappeared in
India.

Pharmaceutical companies have exploited
Prunus africana & Taxus brevifolia to brink of
extinction. Difficult to find signs of regret

Amyris, Spikenard, Rosewood, Cedrela,
Copaiba, Kenyan Cedarwood, Costus presently
especially vulnerable / endangered. No sign of
sustainability considerations.
Sandalwood E.I. Prodn Figs
Year
Sandalwood Sandalwood
prodn tons/yr Oil prodn t/yr
Sandalwood Oil
exported t/yr
1950
1970
5000
4000
150
100
90
60
1980
2000
80
50
1990
1200
50
30
2000
1600
30
10
2004
70
Not known
Not known
2006
--
9
4
Banned ingredients – Peru Balsam

Peru balsam sales in El Salvador halved since
IFRA restriction in 1982

Consequently Peru balsam tree forests
threatened in El Salvador

When ingredients are banned, the socioeconomic out-fall is ignored. EU officials claim
it is not their responsibility.

Technological processing fixes could overcome
adverse ingredient effects – but funding is
elusive.
Peru Balsam Annual Prodn. Figs
Source: Centrex, El Salvador
1976-1980
143 tons/annum
1985-1989
146 tons/annum
1996-2000
91 tons/annum
2001-2005
73 tons/annum
Quote
Félix
de Azúa: "Nobody is safe
from bureaucratic error, and
every day, fewer & fewer
citizens can be sure of getting
or keeping a job."
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
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restrictions on natural aromatics from whichever
directions they come

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
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