““Over-regulation is Destroying Over-regulation is Destroying Natural Aromatics.”Natural Aromatics.”

- Tony Burfield, - Tony Burfield, Co-founder, Cropwatch.Co-founder, Cropwatch.

Presented at the 38Presented at the 38thth ISEO ISEO Conference, Graz, Austria Conference, Graz, Austria

on Wed 12on Wed 12thth Sept 2007 Sept 2007

Cropwatch

Independent Watchdog for the Aroma Independent Watchdog for the Aroma Industry.Industry.

Non-financedNon-financed

No formal membershipNo formal membership

Newsletter subscriber list on website Newsletter subscriber list on website www.cropwatch.orgwww.cropwatch.org

No worries - Lavender cutting in UKNo worries - Lavender cutting in UK

Quote:Quote:

Nietzsche: "Madness is Nietzsche: "Madness is rare in individuals, but rare in individuals, but

common in parties, common in parties, groups & groups & organisationsorganisations.”.”

Nonsensical Over-Regulation of Nonsensical Over-Regulation of AromaticsAromatics

Why has it occurred ?Why has it occurred ?

Why do we put up with it ?Why do we put up with it ?

Has anybody objected & what has happened ?Has anybody objected & what has happened ?

Re: status quo: who’s interests does it suit ? Re: status quo: who’s interests does it suit ?

What can we do about it?What can we do about it?

HyperbureaucraticHyperbureaucratic Technocracy Technocracy

Perfumery/essential oils regulation Perfumery/essential oils regulation hi-jackedhi-jacked by by career toxicologists – EU lawyer alliancecareer toxicologists – EU lawyer alliance

Flurry of over-restrictive measures for aroma Flurry of over-restrictive measures for aroma ingredients based on ‘Precautionary Principle’ ingredients based on ‘Precautionary Principle’

No risk-benefit analysis; No risk quantificationNo risk-benefit analysis; No risk quantification

No typical ‘in-use’ considerationsNo typical ‘in-use’ considerations

No end-user adverse effects evidence allowed No end-user adverse effects evidence allowed by EU Cosmetics Commission by EU Cosmetics Commission

Toxicological ImperialismToxicological Imperialism

Impenetrable ‘big industry toxicology - EU lawyer Impenetrable ‘big industry toxicology - EU lawyer culture’culture’ rules the cosmetics/toiletries/HP area rules the cosmetics/toiletries/HP area

Selective toxicological evidence is forwarded to Selective toxicological evidence is forwarded to ‘expert’ committees - such as SCCP ‘expert’ committees - such as SCCP

Adherence to IFRA/EFFA CoP’s is condition of Adherence to IFRA/EFFA CoP’s is condition of joining some perfumery organisations (!)joining some perfumery organisations (!)

Individuals/groups with contrary views on safety Individuals/groups with contrary views on safety are ignored, or deliberately kept ‘out of the loop’are ignored, or deliberately kept ‘out of the loop’

Over-RegulationOver-Regulation ‘‘Culture of fear’ amongst perfume-buyers arising from Culture of fear’ amongst perfume-buyers arising from

prospect of ingredient safety scares in the mediaprospect of ingredient safety scares in the media

Therefore perfume-buyers require supplier’s guaranteed Therefore perfume-buyers require supplier’s guaranteed adherence to IFRA & EFFA CoP’s, EU Directives etc.adherence to IFRA & EFFA CoP’s, EU Directives etc.

Strict adherence to ingredient restrictions destroys Strict adherence to ingredient restrictions destroys perfumery excellence: creates synthetic junk perfume perfumery excellence: creates synthetic junk perfume scenario.scenario.

The more restrictive the legislation, the lower the The more restrictive the legislation, the lower the volume of natural products used.volume of natural products used.

Culture of ‘chemophobia’Culture of ‘chemophobia’ Career toxicologists/dermatologists have Career toxicologists/dermatologists have

created ‘scare-mongering’ culturecreated ‘scare-mongering’ culture

EU Cosm. Comm. have responded with EU Cosm. Comm. have responded with politically-motivated safety program politically-motivated safety program

So Europe has become a hostile So Europe has become a hostile environment for Aroma trade & many environment for Aroma trade & many companies have relocated outside Europe companies have relocated outside Europe

Over-regulationOver-regulationEssential oils need to conform to/are regulated by:Essential oils need to conform to/are regulated by: National Pharmacopoeias, ISO stds, EOA stds, IFRA National Pharmacopoeias, ISO stds, EOA stds, IFRA

Stds, EFFA CoP’s, FEMA/GRAS, EU Cosm. DirectiveStds, EFFA CoP’s, FEMA/GRAS, EU Cosm. Directive If Biocides, under 98/8/EC. If cosmetics If Biocides, under 98/8/EC. If cosmetics 76/768/EEC. 76/768/EEC. If flavourings, underIf flavourings, under 88/388/EEC, if foodstuffs 188/388/EEC, if foodstuffs 178/200 78/200

EC, if feedstuffs under 70 /524 EECEC, if feedstuffs under 70 /524 EEC . . If Allergic data, to Directive 2003/15/EC amending If Allergic data, to Directive 2003/15/EC amending

76/768/EEC76/768/EEC If Pharmaceuticals If Pharmaceuticals 83/2001/EC; Trad Meds 24/2004/EC83/2001/EC; Trad Meds 24/2004/EC GMO declaration under EC GMO declaration under EC 1829/2003 & EC 1830/20031829/2003 & EC 1830/2003 Heavy metals, dioxins, PCB’s, pesticides, 3-MCPD etc.Heavy metals, dioxins, PCB’s, pesticides, 3-MCPD etc. Labelling & packaging regulations, transport/shipping.Labelling & packaging regulations, transport/shipping.

““26 Allergens” Debacle26 Allergens” Debacle Some of 26 not allergenic e.g. coumarinSome of 26 not allergenic e.g. coumarin

Some of 26 not allergenic enough to require legislation Some of 26 not allergenic enough to require legislation e.g. citronellol, geraniol, anisyl alcohole.g. citronellol, geraniol, anisyl alcohol

Any allergenic effects in CBS’s still to be evaluated for Any allergenic effects in CBS’s still to be evaluated for effects from oxidisable ingredients e.g. linalool, geranioleffects from oxidisable ingredients e.g. linalool, geraniol

Contrary evidence not properly consideredContrary evidence not properly considered

New investigation of SCCP Opinions required under by New investigation of SCCP Opinions required under by independent body – some SCCP committee membersindependent body – some SCCP committee members areare not disinterested partiesnot disinterested parties..

Over-Regulation:Over-Regulation: Environmental Environmental classificationclassification

EcotoxicityEcotoxicity Aquatic environment:Aquatic environment:• • vertebrates – fishvertebrates – fish• • invertebrates – daphniainvertebrates – daphnia• • plants – algaeplants – algae Terrestrial environmentTerrestrial environment - no detailed criteria - no detailed criteria• • mobilitymobility• • persistence and degradabilitypersistence and degradability – – COD/BODCOD/BOD – – Biodegradation studiesBiodegradation studies• • bioaccumulationbioaccumulation – – log Powlog Pow

Natural product use perceived Natural product use perceived to decline in cosmetics ?to decline in cosmetics ?

“ “...essential oils (which currently ...essential oils (which currently appear to be used more in appear to be used more in aromatherapy than in aromatherapy than in perfumery)...”perfumery)...”

Anton C. de Groot, Peter J. Frosch (1997) Anton C. de Groot, Peter J. Frosch (1997)

"Adverse reactions to fragrances. A "Adverse reactions to fragrances. A clinical review." clinical review." Contact DermatitisContact Dermatitis 3636 (2), (2), 57–86. 57–86.

Essential Oil Organisations…Essential Oil Organisations…

Don’t fight the science behind the Don’t fight the science behind the progressive regulatory restrictions progressive regulatory restrictions

Charge $$$’s for membershipCharge $$$’s for membership

Are a closed-shopAre a closed-shop

Are over-deferential to regulators, & sadly, Are over-deferential to regulators, & sadly, are largely ineffectiveare largely ineffective

(A Very) Precautionary Principle(A Very) Precautionary Principle

Not tied into actual risk quantificationNot tied into actual risk quantification

Tied into NOEL of pure ingredient + safety factorTied into NOEL of pure ingredient + safety factor

Matrix effects not consideredMatrix effects not considered

Usage conditions not consideredUsage conditions not considered

Risk-benefit analysis not performedRisk-benefit analysis not performed

End-user adverse effect data not allowable as End-user adverse effect data not allowable as evidence (stated EU policy) evidence (stated EU policy)

(A Very) Precautionary Principle(A Very) Precautionary Principle Has frozen EU natural biocides industry & halted Has frozen EU natural biocides industry & halted

innovation.innovation. Only 2 natural biocides remain supported in 2Only 2 natural biocides remain supported in 2ndnd

Phase of Review Process of Active Substances Phase of Review Process of Active Substances in the BPD of the EU (garlic oil & margosa oil)in the BPD of the EU (garlic oil & margosa oil)

Industry too small to support safety studiesIndustry too small to support safety studies USA does not restrict natural biocidesUSA does not restrict natural biocides Other govts consider essential oils as ‘of low Other govts consider essential oils as ‘of low

toxicological safety concern’toxicological safety concern’ Natural biocides industry has no trade assocn – Natural biocides industry has no trade assocn –

so regulatory stalemate!so regulatory stalemate!

Quote:Quote:

Fenn R.S. (2005) “Europe’s Fenn R.S. (2005) “Europe’s obsession with the obsession with the

precautionary principle is precautionary principle is stultifying our creativity”stultifying our creativity”

Perfumer & FlavoristPerfumer & Flavorist vol 30 (Jan/Feb vol 30 (Jan/Feb 2005) p 25.2005) p 25.

Quote:Quote: Frank Kafka: Frank Kafka:

“… “…it must be suspected that, it must be suspected that, paradoxically, that these (scientific) paradoxically, that these (scientific) fundamentalists have contributed in fundamentalists have contributed in creating or preserving the most fearful creating or preserving the most fearful & oppressive fictions.”& oppressive fictions.”

Quote: Cropwatch (2007):Quote: Cropwatch (2007):

The EU Commission should require a The EU Commission should require a precautionary approach which highlights precautionary approach which highlights the areas of uncertainty and absence of the areas of uncertainty and absence of information, which will then provide a information, which will then provide a much better basis for decisions about much better basis for decisions about whether to proceed. At present pressure to whether to proceed. At present pressure to proceed is unrelenting even in absence of proceed is unrelenting even in absence of comprehensive toxicological data e.g. over comprehensive toxicological data e.g. over the intention to restrict FCF’s in cosmetics.the intention to restrict FCF’s in cosmetics.

Need for EU Fragrance Need for EU Fragrance CommissionCommission

Fragrance is used in other areas than cosmetics Fragrance is used in other areas than cosmetics e.g. household products, aerosols, e.g. household products, aerosols, environmental fragrancing, candles & incense, environmental fragrancing, candles & incense, reodourants etc. reodourants etc.

Perfume is about art, heritage & culture. EU Perfume is about art, heritage & culture. EU Cosm. Directives have socio-economic & Cosm. Directives have socio-economic & ecological fall-out effects. EU Cosm. Comm. ecological fall-out effects. EU Cosm. Comm. refuses all above responsibilities, apart from refuses all above responsibilities, apart from (politically compliant) safety aspects.(politically compliant) safety aspects.

Natural Ingredient RestrictionsNatural Ingredient Restrictions

EU Cosm. DirectivesEU Cosm. Directives

EFFA CoPEFFA CoP

4040thth-42-42ndnd IFRA Amendment & IFRA Stds IFRA Amendment & IFRA Stds

Dangerous substances Regs (CHIP in Dangerous substances Regs (CHIP in UK); Dangerous Preparations DirectiveUK); Dangerous Preparations Directive

REACHREACH

4040thth Amendment to IFRA CoP Amendment to IFRA CoP

Has ruined spontaneous creativity in perfumery Has ruined spontaneous creativity in perfumery

Perfume creation now merely a software Perfume creation now merely a software exerciseexercise

Excessive red-tape mitigates against SME’s Excessive red-tape mitigates against SME’s

Back-lash amongst natural perfumers, crafters, Back-lash amongst natural perfumers, crafters, soap-makers (>920 signed Cropwatch petition soap-makers (>920 signed Cropwatch petition against 40against 40thth Amendment which IFRA ignored). Amendment which IFRA ignored).

IFRA StandardsIFRA Standards

Progressively reduce use of naturals in Progressively reduce use of naturals in fragrance formulations. Contrarily, fragrance formulations. Contrarily, consumers want perfumes with consumers want perfumes with guaranteed naturals content! guaranteed naturals content!

Minor ingredient safety studies abandoned Minor ingredient safety studies abandoned due to economic considerationsdue to economic considerations

Major worries now over future situation Major worries now over future situation regarding ethanol, citrus oils etc.regarding ethanol, citrus oils etc.

Examples of Restriction.Examples of Restriction.

Oakmoss Oakmoss – foundation of Coty’s – foundation of Coty’s ChypreChypre, , Guerlain’s Guerlain’s MitsoukoMitsouko, Dior’s , Dior’s Miss DiorMiss Dior..

StyraxStyrax – once important perfumery ingredient – – once important perfumery ingredient – now only exists as flabby neutralised products.now only exists as flabby neutralised products.

Minor oilsMinor oils banned IFRA (lack of funds to banned IFRA (lack of funds to investigate): Melissa, Santolinainvestigate): Melissa, Santolina

Cinnamon leaf oil (& Clove oil)Cinnamon leaf oil (& Clove oil) – used in – used in potpourris, candles but R43 issues mean potpourris, candles but R43 issues mean replacement with methyl cinnamic ald. etc.replacement with methyl cinnamic ald. etc.

Examples of Restriction (2).Examples of Restriction (2).

No one wants environmental labelling – R50/53 No one wants environmental labelling – R50/53 dead fish/dead tree symbol on product. dead fish/dead tree symbol on product.

(Cheap) Citrus oils (Cheap) Citrus oils have traditionally been used have traditionally been used in many types of air fresheners, particularly in many types of air fresheners, particularly wicks & gels, for their diffusion, lift & character wicks & gels, for their diffusion, lift & character but perfumers now find it difficult to use them at but perfumers now find it difficult to use them at useful levels because of R50/53 labelling. Ditto useful levels because of R50/53 labelling. Ditto for pine oils.for pine oils.

Examples of Restriction (3)Examples of Restriction (3)

FCF’s in Citrus oils. Citrus oils occupy a unique FCF’s in Citrus oils. Citrus oils occupy a unique place in perfumery esp. bergamot oil place in perfumery esp. bergamot oil

Restriction of Restriction of FCF’s to 1 ppm in finished FCF’s to 1 ppm in finished cosmetics will cause chaoscosmetics will cause chaos

SME’s in S. America, Cuba, Africa etc. with no SME’s in S. America, Cuba, Africa etc. with no FCF reducing technology liable to be more FCF reducing technology liable to be more affected than big concerns elsewhereaffected than big concerns elsewhere

Examples of Restriction (4)Examples of Restriction (4)

Methyleugenol (ME)Methyleugenol (ME) IFRA limits:IFRA limits: Fine fragrance: 0.02% Eau de toilette: 0.008%Fine fragrance: 0.02% Eau de toilette: 0.008% Fragrancing cream: 0.004% Other leave on: 0.0004%Fragrancing cream: 0.004% Other leave on: 0.0004% Rinse-off: 0.001% Non skin: 0.02% - conc in fragrance Rinse-off: 0.001% Non skin: 0.02% - conc in fragrance

compoundcompound Other non cosmetic products not covered above: 0.001%Other non cosmetic products not covered above: 0.001%

Many natural products contain ME from pimento leaf Many natural products contain ME from pimento leaf oil to nutmeg oil restricting their use. Contrary oil to nutmeg oil restricting their use. Contrary evidence on ME carcinogenicity never considered, evidence on ME carcinogenicity never considered, new research not evaluated, review long overdue.new research not evaluated, review long overdue.

Examples of over-exploitationExamples of over-exploitation

Sandalwood. Forests all but disappeared in Sandalwood. Forests all but disappeared in India.India.

Pharmaceutical companies have exploitedPharmaceutical companies have exploited Prunus africanaPrunus africana & & Taxus brevifolia Taxus brevifolia to brink of to brink of extinction. Difficult to find signs of regretextinction. Difficult to find signs of regret

Amyris, Spikenard, Rosewood, Cedrela, Amyris, Spikenard, Rosewood, Cedrela, Copaiba, Kenyan Cedarwood, Costus presently Copaiba, Kenyan Cedarwood, Costus presently especially vulnerable / endangered. No sign of especially vulnerable / endangered. No sign of sustainability considerations. sustainability considerations.

Sandalwood E.I. Prodn FigsSandalwood E.I. Prodn Figs

YearYear SandalwoodSandalwood prodn tons/yrprodn tons/yr

Sandalwood Sandalwood Oil prodn t/yrOil prodn t/yr

Sandalwood Oil Sandalwood Oil exported t/yrexported t/yr

19501950 50005000 150150 9090

19701970 40004000 100100 6060

19801980 20002000 8080 5050

19901990 12001200 5050 3030

20002000 16001600 3030 1010

20042004 7070 Not knownNot known Not knownNot known

20062006 ---- 99 44

Banned ingredients – Peru BalsamBanned ingredients – Peru Balsam

Peru balsam sales in El Salvador halved since Peru balsam sales in El Salvador halved since IFRA restriction in 1982 IFRA restriction in 1982

Consequently Peru balsam tree forests Consequently Peru balsam tree forests threatened in El Salvador threatened in El Salvador

When ingredients are banned, the socio-economic When ingredients are banned, the socio-economic out-fall is ignored. EU officials claimout-fall is ignored. EU officials claim

it is not their responsibility.it is not their responsibility.

Technological processing fixes could overcome Technological processing fixes could overcome adverse ingredient effects – but funding is elusive. adverse ingredient effects – but funding is elusive.

Peru Balsam Annual Prodn. FigsPeru Balsam Annual Prodn. FigsSource: Centrex, El SalvadorSource: Centrex, El Salvador

1976-19801976-1980 143 tons/annum143 tons/annum

1985-19891985-1989 146 tons/annum146 tons/annum

1996-20001996-2000 91 tons/annum91 tons/annum

2001-20052001-2005 73 tons/annum73 tons/annum

QuoteQuote

Félix de Azúa: "Nobody is safe Félix de Azúa: "Nobody is safe from bureaucratic error, and from bureaucratic error, and every day, fewer & fewer every day, fewer & fewer citizens can be sure of getting citizens can be sure of getting or keeping a job."or keeping a job."

Join Cropwatch!Join Cropwatch!

We actively fight nonsensical regulatory We actively fight nonsensical regulatory restrictions on natural aromatics from whichever restrictions on natural aromatics from whichever directions they comedirections they come

We share information & don’t charge feesWe share information & don’t charge fees

If you can offer to work as a volunteer, we can If you can offer to work as a volunteer, we can offer long hours, no pay, an opportunity to be offer long hours, no pay, an opportunity to be ignored by powerful organisations & officials, & ignored by powerful organisations & officials, & unfairly criticised by the trade press…… but….unfairly criticised by the trade press…… but….

WE ARE WE ARE DETERMINED DETERMINED TO CHANGE TO CHANGE THINGS !THINGS !