“Over-regulation is Destroying Natural Aromatics.” - Tony Burfield, Co-founder, Cropwatch.

1. “Over-regulation is Destroying Natural Aromatics.”- Tony Burfield, Co-founder, Cropwatch. Presented at the 38th ISEO Conference, Graz, Austria on Wed 12th Sept 2007

2. Cropwatch • Independent Watchdog for the Aroma Industry. • Non-financed • No formal membership • Newsletter subscriber list on website www.cropwatch.org

3. No worries - Lavender cutting in UK

4. Quote: Nietzsche: "Madness is rare in individuals, but common in parties, groups & organisations.”

5. 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?

6. 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

7. 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’

8. 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.

9. 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

10. 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, under88/388/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.

11. “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 membersarenot disinterested parties.

12. 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

13. 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 Dermatitis36 (2), 57–86.

14. Essential Oil Organisations… • Don’t fight the science behind the progressive regulatory restrictions • Charge $$$’s for membership • Are a closed-shop • Are over-deferential to regulators, & sadly, are largely ineffective

15. (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)

16. (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!

17. 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.

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

19. 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.

20. 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.

21. Natural Ingredient Restrictions • EU Cosm. Directives • EFFA CoP • 40th-42nd IFRA Amendment & IFRA Stds • Dangerous substances Regs (CHIP in UK); Dangerous Preparations Directive • REACH

22. 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).

23. 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.

24. 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.

25. Examples of Restriction (2). • No one wants environmental labelling – R50/53 dead fish/deal 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.

26. 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

27. 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.

28. Examples of over-exploitation • Sandalwood. Forests all but disappeared in India. • Pharmaceutical companies have exploitedPrunus 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.

29. Sandalwood E.I. Prodn Figs

30. 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 socio-economic out-fall is ignored. EU officials claim it is not their responsibility. • Technological processing fixes could overcome adverse ingredient effects – but funding is elusive.

31. Peru Balsam Annual Prodn. FigsSource: Centrex, El Salvador

32. 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."

33. Join Cropwatch! • We actively fight nonsensical regulatory restrictions on natural aromatics from whichever directions they come • We share information & don’t charge fees • If you can offer to work as a volunteer, we can offer long hours, no pay, an opportunity to be ignored by powerful organisations & officials, & unfairly criticised by the trade press…… but….

34. WE ARE DETERMINED TO CHANGE THINGS !