Toxic & Harmful Substances in Complex Materials of Botanical Origin,
and Other Frequently Required Information from Essential Oil Traders.
[Expanded from Cropwatch Newsletter No 4].
Copyright Ó Cropwatch Sept 2006.
Essential oils and other natural aromatic botanical products are widely used in the pharmaceutical, vetinary, flavour (food & feed trades), cosmetics & perfumery professions, and are employed as biocides & in traditional medicines the world over. They are used also in aromatherapy & home remedies, and, with the possible exception of aromatherapy, are subject to a wide range of overlapping regulations. Limits for specific contaminants or harmful substances, are amongst common regulatory requirements for traded essential oils, absolutes, oleoresins & other raw material ingredients of botanical origin, & as such, may be requested by customers as demanded by the existing laws operating in many countries, or simply in order to conform to specific customers international buying policies. These requirements may need producer statements for the following subject areas (please notify any corrections or comments to email@example.com in order to help us improve this document):
Following pressure from influential Danish dermatologists, an SCCNFP Opinion on Allergens was devised, & has been incorporated into EU legislation under the Directive 2003/15/EC, amending Directive 76/768/EEC. The original 6th Amendment of the Cosmetics Act 93/95/EEC required the word parfum to be added to the labelling of fragranced cosmetics - this applied even to circumstances in which there was one component only present (such as an individual essential oil). The subsequent legislation 2003/15/EC Directive relates to a labelling disclosure about the presence of any of the 26 alleged allergens in cosmetic products, 16 of which occur in natural botanical products (including essential oils). The sixteen SCCNFP allergens occurring in natural products are:
para-Anisyl alcohol; Benzyl alcohol; Benzyl benzoate; Benzyl cinnamate; Benzyl salicylate; Cinnamic aldehyde; Cinnamyl alcohol; Citral; Citronellol; Coumarin; Eugenol; Farnesol; Geraniol; Isoeugenol; Limonene; Linalool.
In spite of widespread protests, the EU regulators in their wisdom have decided not to make a distinction regarding the origin of the allergens, therefore they can apply to essential oils & essential oil blends just as much to synthetic or part-synthetic fragrances, or indeed to their artefacts. The allergens content must be calculated for potential labelling purposes, & if the concentration of the individual allergen noted above is above 100ppm (= 0.01%) in products washed off the skin, or 10 ppm (= 0.001%) in fragranced products left on the skin.
The new QRA approach outlined in IFRA’s 40th Amendment (see elsewhere in this newsletter) will replace this leave-on / wash-off system with a system more related to dose per unit area of skin type. It represents even more red tape & required calculations for perfumers, who’s creative time is progressively reducing as legislative duties correspondingly increase.
For Allergen Intolerance Data, see Food Intolerance Data section below.
For legal reasons, or to suit “green” buying policies, buying customers frequently want to know details of any Animal Testing performed on botanical products after 11 Sept 2004 (a transitory period was granted for animal testing before its proposed phasing-out according to the 7th Amendment of the EU Cosmetics Directive 76/768/EC), or testing prior to 11 Sept 2004, but after 1976. New methods of testing need to be adopted by standardising bodies such as the OECD.
Stating the correct Latin binomial botanical nomenclature for an aromatic commodity of botanical origin, along with the naming botanist, is rarely successfully accomplished by aroma traders. However, a listing of one hundred & sixty three botanical names of common essential oils, together with naming botanist, common names in English & French, and part of plant used, are set out in ISO standard No. ISO 4720 (2nd edn. 2002). The list needs updating, and does not distinguish different chemotypes, geographic origins, or include crop maturity stage harvesting details, so cannot totally define the status/likely composition of the essential oil […but it’s a start!].
Unfortunately, for some unfathomable reason, much data which is rubber-stamped by EU regulators & the European Chemicals Bureau for website display often does not conform to best practice wrt botanical nomenclature, as set out by the latest publications of The International Code of Nomenclature for Cultivated Plants, and The International Code for Botanical Nomenclature (see www.users.globalnet.co.uk/~nodice/new/essential/essential1.htm). Instead we have the dreaded INCI list (q.v.). This is strange because, conversely, chemical nomenclature usually does conform to best practice via the rules set out by the corresponding chemical systematics naming body IUPAC. This situation (as Cropwatch can attest) has lead to a considerable amount of confusion, but there is seemingly no real interest by regulators in any move to remedy the situation.
California Proposition 65.
Deriving from the Safe Drinking Water & Toxic Enforcement Act (1986), Prop. 65 is a list of some 750 chemicals known to cause cancer or reproductive toxicity. A useful guide to this legislation can be found at http://www.oehha.ca.gov/prop65/prop65_list/Newslist.html from which a current downloadable list of identified chemicals is also available.
Cropwatch comments: Interestingly & controversially the current list (Aug 2006) includes estragole. The inclusion of tobacco smoke is puzzling – perhaps serious questions need to be asked about what happens when consumers turn their domestic water taps on, in California!
California Senate Bill 484 (California Safe Cosmetics Act, 2005).
Signed by Gov. Arnold Schwarznegger, the legislation requires that manufacturers list by 01.01.2007, all cosmetics & personal care products sold in California, along with the identification of any ingredients, together with their CAS Nos, of any identified by authoritative bodies (National Toxicology Program, US EPA, California’s Prop. 65) of causing cancer or reproductive toxicity (Note: there is apparently no minimum concentration for which reporting would be required, … or a suitable expert body who might oversee the legislation).
The Chemical Abstracts Service (a division of the American Chemical Society) assigns a unique chemical identifier number to chemical compounds, botanical extracts etc. etc. There are currently just under 30 million numbers allocated; some now regard it as a universal identification number. For example Eucalyptus oil from Eucalyptus globulus Labille. has a CAS No, (US) 8000-48-4 & CAS No. (EU) 84625-32-1. Problems have arisen where duplication exists, or where incorrect assignment of numbers to appropriately defined, botanically derived extracts, occurs.
Quoting from the Agency for Toxic Substances & Disease Registry http://www.atsdr.cdc.gov/cercla/#bookmark04:
“The Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) section 104 (i), as amended by the Superfund Amendments and Reauthorization Act (SARA), requires ATSDR and the EPA to prepare a list, in order of priority, of substances that are most commonly found at facilities on the National Priorities List (NPL) and which are determined to pose the most significant potential threat to human health due to their known or suspected toxicity and potential for human exposure at these NPL sites.” Downloads of the current list are available from this site.
Chemical Hazard Information & Packaging Regulations (CHIP) were introduced in 1994 and subsequently amended; eventually the Dangerous Preparations Directive (1999/45/EC) was implemented in the UK (July 2002) as CHIP 3, the Directive outlining the classification and labelling requirements for preparations (mixtures of chemicals) including household products & some fragrances (depending on concentration present).
IFRA-IOFI-EFFA have produced listings of hazard & risk codes of flavour & fragrance ingredients to suit European legislation, a task which will now revert to EFFA (& which will apparently become a “Code of Practice”). The BEOA has in recent years produced an annual CHIP guidance list on essential oils and some heavily traded aroma chemicals for its (UK) members (and may of course continue to do so), but it is understood that EFFA will produce information on hazards for essential oils in future.
Many professional perfumers have software programs to help them work out the CHIP status of formulae automatically - for example for definitive R10, R38, R43 and R50-53 status etc., and to warn of closeness to IFRA ingredient limits etc. The rest of us have to use a calculator.
Some customers require provision of analytical details for the total content of chlorinated organics per unit weight of the product (see Pesticides section).
Some maintain that in many cases these approximate to:
Natural substances 21 CFR 172.510
Artifical substances 21 CFR 172.515
Spices/seasonings & flavourings 21 CFR 182.10
Essential oils, oleoresins & natural extracts 21 CFR 182.20
Stands for Carcinogenic, Mutagenic & Reproductive toxicity status, customers may ask about substances listed in the CMR classification according to EEC/548/675 DSD Directives Since little specific data exists in these categories for essential oils, the synthetic chemicals lobby (worried about the competition from natural materials) has had a field day influencing the safety regulators. This means that for example in the Biocides area, perfectly safe, low toxicity, fully biodegradable essential oils will not now legally be allowed for sale in Europe as retailed products in most biocidal categories from 1st Sept 2006. This leaves the European public without a natural biocidal product consumer choice option, only products containing arguably more toxic, bio-accumulative, and in some cases, quite possibly carcinogenic, synthetic biocides. This is exactly how bureaucratic bungling turns a sensible law designed to protect the health of EU citizen into regulations which put public health more at risk.
Applies to whether the material is classified as dangerous under 67/548/EEC (amended 9 times, including 79/831/EEC & the Preparations Directive 88/379/EEC). Annex 1 includes some 8000 new and existing substances for which labelling has been agreed. Generally a catch-all category for preparations outside the reach of other categories; some commentators call this the ‘R43 Act’.
Dietry & Nutritional Data.
Current Kosher certificates may need to be provided for specific purchases: questionnaires may need to be completed wrt contained ingredients or contact with ingredients of animal origin, seafood (incl. fish), grape or wine sources, or those derived from dairy (milk). Current Halal certificates may need to be provided for specific purchases. Suitability for Vegans. Lacto-Vegetarians, Ovo-lacto-vegetarians & Celiacs may be requested.
Nutritive value data also may be requested under EU Directive 90/496 or NLEA 21 CFR 101 (this data not applicable to essential oils). Food intolerance data (see section below) may need to be provided.
Dioxins & Dioxin-like PCB’s.
Dioxins, which the WHO concludes are non-genotoxic carcinogens, are regulated under 2375/2001 & 1998/53/EEC; for example the concentration in vegetable oils should be <0.75pg/Kg.
Commission Regulation EC No 199/2006 (Feb 2006) refers to “ ‘Dioxins’ … a group of 75 polychlorinated dibenzo-p-dioxin (PCDD) congeners and 135 polychlorinated dibenzofuran (PCDF) congeners, of which 17 are of toxicological concern. Polychlorinated biphenyls (PCBs) are a group of 209 different congeners, which can be divided into two groups according to their toxicological properties: a small number exhibit toxicological properties similar to dioxins and are therefore often termed ‘dioxin-like PCBs’. The majority do not exhibit dioxin-like toxicity but have a different toxicological profile.” All operators in the food/feeds chain must endeavor to keep levels of dioxins & PCB’s down according to limits set out in Regulation (EC) No 466/2001, which will be reviewed in Dec 2006.
[Cropwatch comments: Lets face it, most essential oil traders do not have the facilities to test for dioxins or PCB’s, or the spare capital to invest in the expensive equipment required. It is difficult to see therefore how these laws will be effectively & fairly employed in this area, unless the trading is left to those few large corporate concerns who can afford the equipment. Or, say, unless the Government Chemist offers free testing to financially disadvantaged aroma traders?].
EINECS (European Inventory of Existing Chemical Substances).
Register of chemical substances commercially available in EU from 1971 to 1981, created by EC Directive 67/548/EEC. Was replaced in Sept. 1981 by ELINCS (q.v.).
ELINCS (European Inventory of Existing Chemical Substances).
Both EINCS & ELINCS numbers are now superceded by EC number. The ESIS data-base can be searched through CAS # (EU), EC #, or common names (includes essential oils), can be accessed at http://ecb.jrc.it/esis/esis.php?PGM=ein .
Details of the precise effects of pollutant chemicals on ecosystems are scarce for the essential oil category, and anyway biodegradation may occur ahead of any untoward toxic effects. Unfortunately, armchair modelling – sorry, (QSAR) Quantitative Structure Activity Relationships modelling - is increasingly used as a surrogate, instead of doing any actual work. Sorry, fieldwork. In this way very Persistent, very Bioaccumulative materials (vPvB) can theoretically be identified. An example of this is the DEFRA Horizon scanning programme (DH 2004) Future Effects of Non-Synthetic Chemical Use, which in one aspect, explored the accumulation of substances which might pose a hazard materials from increased use of essential oils in CAM and…wait for it… pesticide use (see elsewhere in this newsletter to understand the irony here!). However, this is, in a lot of ways, an admirable and ambitious piece of work and there is no intention criticise unnecessarily. The surprise is the list of predicted problematic environmental substances includes α-terpineol, neryl acetate, geranyl acetate, limonene terpinyl acetate, and valencene. The authors admit they did not consider microbial biodegradation by soil micro-organisms (or presumably photo/auto-oxidation & other reactive fates) and quite frankly, unless this is programmed into the number crunching, the results in this particular case may be quite worthless.
Elsewhere, the ultimate ‘bad science’ situation has already arrived, where surrogate compounds, for which there just happens to already be some eco-toxicity data, are substituted for essential oils on an arbitrary basis e.g. the reactive aldehydic substance citral, for citronella oil Java-type Cymbopogon winterianus Jowitt, in the PAN Pesticides Database (itself derived from sources such as the EPA’s AQUIRE database). The scholars amongst you will have already spotted that citronella oil Java contains virtually no citral at all – but apparently this is not a valid point! Cropwatch has already argued by mail with PAN staff that this policy is reprehensible, and they agree that surrogate substances are indeed arbitrary designated, but, seemingly, there is no actual momentum to be able to change anything. We then find that various safety regulators cite this arbitrary surrogate data for specific actives, as if it were proven fact, in their environmental regulatory decisions (as has already happened in Canada & UK). Since appealing against the individual decisions of regulators for any one active substance usually involves parting with tens of thousands of pounds sterling in fees, it is difficult to see how any common sense will ever prevail here - well, short of some sort of Judicial Review.
Solvent products used in production of foodstuffs & food ingredients need to correspond to EU Council Directive 88/344/EEC and amendments (92/115 EEC, 94/52/EC; 97/60/EC) relating to extraction solvents. Readers may find web pages at http://europa.eu/scadplus.leg/en/lvb/12114.htm useful for further information. Limits on solvents in (food) oleoresins are sometimes specifically stipulated in Codex monographs e.g. in FCC IV & supplements.
Customers ask for data on any residual quantities (mg/Kg) of any of the following solvents:
Propane, Butane, Ethanol, Ethyl acetate, Acetone, Methanol, Methyl acetate, Hexane, Ethyl methyl ketone, Carbon Dioxide, Nitrous oxide, Propan-1-ol, Propan-2-ol, Butan-1-ol, Butan-2-ol, 1,1,1,2-Tetrafluoroethane, 1,1,2-Trichloroethane, Dichloromethane, Cylcohexane etc.
[Cropwatch comments: Some essential oils – especially ‘extended’ oils - are enhanced with certain food colourings to make them appear ‘more normal’ in appearance]. Any food colours used for this purpose need to correspond with EU Directive 95/45/EEC.
Food Intolerance Data.
The Directive 2003/89/EC (amending 2001/13/EC) may require the supplier to give details on the presence or possibility of cross-contamination for the following items, according to Annex 3a:
Peanuts/tree nuts and derivatives (including Cashew, Walnut, Hazlenut, Brazil, Pistachio,
Almond, Pecan, Macadamia & Queensland)
Mustard & derivatives
Celery and derivatives
Eggs and derivatives
Sesame seeds and derivatives
Gluten containining products i.e. wheat, barley, rye, oats, spelt, kamur - hybrids & products.
Dairy products including milk and lactose
Sulphur dioxide & Sulphites at > 10mg/Kg or 10mg/l SO22-.
Some suppliers may ask for additional information regarding the presence of:
Beef Meat; Pork meat; Chicken meat
Cinnamon & derivatives
Azorubine, Carmoisine (E122)
Brilliant Black (E151)
Orange Yellow S (E110)
Cochineal Red A (E124)
EU Flavis Data-Base.
The EU Flavour information system FLAVIS (Flavis Nos. are regarded as replacing outdated CoE Nos) contains approx 2,748 chemically defined substances (but not as far as we can see, essential oils etc.) and can be viewed at http://ec.europa.eu/food/food/chemicalsafety/flavouring/database/
Food Grade Status.
Food flavourings/essential oils etc. may required to be declared Food Grade according to General Food Law Regulation EU/178/2002 as well as complying to EU 88/388 etc.
Although phototoxic status is has not required to be stated under CHIP labelling regulations, an SCCP Opinion has proposed a revision of the limits for furanocoumarins (FCF’s) in cosmetics from 15ppm down to 1ppm. Cropwatch has established to its own satisfaction (summer 2006) that many aroma industry workers, especially working perfumers, are largely unaware of the actual FCF content of common aromatic raw materials of the Rutaceae & Apiaceae. This illustrates a credibility gulf between those concerned with legislation and those concerned with its implication, and will provide an interesting situation with regard to the forthcoming 40th IFRA Amendment (see Nobody Expects the Spanish Inquisition in Cropwatch Newsletter No 4).
GRAS (Generally Recognised As Safe) or FEMA-GRAS Status.
A Q & A section about GRAS status can be found at www. cfsan.fda.gov/~dms/grasguid.htm#Q8 which essentially says: “Under the authority of Section 201(s) & 409 which are the 1958 Food Additives Amendments to the Federal Food Drug & Cosmetic Act (FDCA: enacted 1938)… & FDA’s implementing regulations in 21 CFR 170.3 & 21 CFR 170.30, the use of a food substance may be GRAS either under scientific procedures, or for a substance used before 1958, through experience based on common use in food.” [the FDCA actually says “safe under conditions of intended use” and “adequately shown through scientific procedures.”]. In other words there is little about what is required in the way of official guidance for GRAS status, and some flavourings producers have taken to using third party safety reviewing committees (although it is not clear to Cropwatch if these committees are directly paid by the flavourings producers for these reviews). Nevertheless there are some 2000 materials that have GRAS status (GRAS materials are listed in the Journal of Food Technology).
Cropwatch comments further: Flavouring essential oils are often organoleptically appraised by flavour technicians at 0.01% (10 ppm) in diluted sugar syrup; the literature indicates that we might consume essential oils in foods at a level of around 15 to 20 parts per million (as "the level required to produce the desired effect"), and presumably this is the sort of dose that the GRAS status should ideally refer to. With several books & articles on cooking with essential oils currently appearing in magazines & in high-street shops, now is the time perhaps to make recommended concentration limits clear: after all what is GRAS at 20 ppm may present a health risk at higher concentrations.
These regulations apply in Europe: GM-free Certification wrt EEC Regulation 2092/91/EGW Biological Agriculture, and GM Food/Feed Regulation 1829/2003 (22nd Sept 2003): & 1830/2003 (22 Sept 2003) concerning the Traceability & Labelling of Food & Feed products from GMO’s (amending Directive 2001/18/EC.
In other words, you might get the message that GM-derived flavourings are not welcome in EU food & feed products (!).
Producers/traders may also be asked if the product provided contains any of the following plants or products (which have been associated with GM modification):
Chicory, cotton, flax (linseed), maize, melon, papaya, potato, rape (canola), rice, soybean, squash/pumpkin, sugar beet, tomato, wheat.
HACCP (Hazard Analysis & Critical Point Methodology).
Originally regarded as a food safety management system utilising a systematic, science-based approach to identifying & controlling hazards (see http://www.fao.org/DOCREP/005/Y1579E/y1579e03.htm), HACCP methodology, with its attention directed at prevention rather than end-product testing, is now applied to many other industries. Refreshingly, some producers are highly critical of this methodology. A paper containing elements of an in-depth narrative interview with a small farm-owner resistant to HACCP methodology has been published (Taylor & Taylor 2004) which seeks to uncover reasons for the lack of implementation success for HACCP in small businesses. Cropwatch comments: we actually agree with many of the farmer’s perceptions: observed lack of credibility/competence of officials & authorities, impractical, futile & insulting paperwork & formalities etc. etc. In our view, HACCP methodology has become a buck-passing exercise between producers, traders, customers and health officials, each attempting to absolve themselves of responsibility for everyday working transactions.
[Cropwatch comments: heavy metal contamination can occur via leaching from metal containers or metal processing plant etc; Zheljazkov et al. (undated) concluded that Mentha oils produced from plant material grown in high heavy metal content soils were not unduly high in heavy metal content.]
EU Council Directive 88/388/EEC, relating to flavourings for use in foodstuffs and source materials for their production (i.e. may include essential oils), requires that:
In addition some customers may require further limits e.g. Copper <1mg/Kg, Iron Fe<1mg/Kg, Zinc Zn <1mg/Kg etc.
A list of ingredients ordered by INCI name can be currently found at http://ec.europa.eu/enterprise/cosmetics/inci/inci_2006.pdf (they keep moving it!). This antique piece of history has been widely criticised, is botanically inaccurate, outdated & outmoded, desperately needs revision, & does not follow best practice wrt botanical nomenclature, as set out by The International Code of Nomenclature for Cultivated Plants, and The International Code for Botanical Nomenclature. Furthermore it is unethical in principle, in that includes threatened & vulnerable species subject to restrictions under current EU Directives. Apart from that, it’s fine.
For essential oil blends/natural perfumes, a certificate of compliance to the 39th IFRA Amendment is sometimes requested.
A forthcoming 40th IFRA Amendment, will perhaps (God help us) change the basis on with fragrance use restrictions apply away from the present system to a Quantitative Risk Assessment (QRA) approach, based on the dose of perfume per unit area of skin (see http://www.ifraorg.org/Enclosures/News/Technical%20Dossier%20FINAL%20REVISED%202006%205%2026.pdf), also taking various other factors (such the dose vehicle) into account. It is reported in the trade press (and we reproduce this in good faith) that in a second proposed development, a third party monitoring system & laboratory will function to ensure the IFRA members comply to the IFRA code of regulations (!). We understand that if disallowed substances are found in finished fragrances, or other non-compliance is observed, the guilty party will have to explain itself to IFRA, and if continued non-compliance is discovered … well, we’ll just have to leave it to our readers to imagine the consequences! If this development doesn’t have fragrance companies leaving IFRA in droves & joining Cropwatch, then we don’t know what will.
[Cropwatch comments: 3-Monochloropropane-1,2-diol (3-MCPD) is regarded as a genotoxic carcinogen which can be generated by steam distilling proteinaceous material (as would be found in the aromatic leaves, stems, roots etc. of plants) with chlorinated mains water. It has been found to be a problem in soy & oyster sauces (produced from hydrolysed protein) and in sterilized herbs, but it can also occur in essential oils].
For foodstuffs & food ingredients, the product must conform to Council Directive 466/2001 EEC (March 2001) regarding 3-MCPD content, which needs to be at an undetectable level (detection limits taken by some to be 0.2ng/Kg in hydrolysed vegetable protein).
Material Safety Data Sheets (MSDS).
Generally required with delivered goods according to OSHA: CFR 1910: 1200 (US) or 91/155/EEC & 2001/58/EC, which carry on from Article 10 of Directive 88/379/EEC. Details of the obligatory 16-point information system template for MSDS sheets are set out in 91/155/EEC. These are:
1. Identification of the substance & company undertaking
2. Composition information on ingredients
3. Hazards identification
4. First aid measures
5. Fire fighting measures
6. Accidental release measures
7. Handling & storage
8. Exposure controls & personal protection
9. Physical & chemical properties
10. Stability & reactivity
11. Toxicolgical information
12. Ecological information
13. Disposal considerations
14. Transport information
15. Regulatory information
16. Other information
For example, under Section 9, details of the product’s flash-point, boiling-point, vapour pressure, auto-ignition temperature, upper & lower flammability limits, water solubility, hazardous decomposition products on ignition etc. may be listed since they are of especial use in the case of an emergency situation.
The technical level of information on essential oils presented by many traders in MSDS sheets is often extremely poor; customers are reminded they have the legal right to demand from their suppliers a level of information which they can both understand and which is suitable for purpose.
[May not be directly applicable to essential oils, oleo-resins etc. since by their very (non-aqueous) nature they may not support microbial growth, or show bacteriostatic or anti-microbial properties].
Foodstuffs must comply with 4006/2001 EEC & amendments wrt max levels of aflatoxin, ochratoxin & patulin. Regulation 47/2002 & Directives 2002/27/EC & 2002/26/EC apply so that:
Certificates of Naturalness under natural flavour/flavouring substances regulations:
US: 21 Code of Federal Regulation (CFR) 101.22(a)3 - 100% derived from named source.
EEC: Regulation 88/388/EEC (22.6.88) article 1, §2 (b) (i) – natural aromatic substance 90%+ derived from named source, or article 1, §2 (c) – natural aromatic preparation.
and/or fragrance ingredients for products, as defined under:
ISO 9325 Article 9 Sect 2. The criteria for Natural Cosmetics under guidelines proposed by the Committee of Experts on Cosmetic Products 2000.
The certificate should indicate the percentage of botanically derived materials from the named species present, together with percentages of any additives, anti-oxidants etc.
According to Walden & Holton (2005), for flavourings in the US, organic status can be gained if the material contains solely flavouring constituents & meets the US FDA 21 CFR 101.22 requirements. The National List of Allowed & Prohibited Substances disallows synthetic solvents and carrier systems, and artificial preservatives in natural flavourings.
The US Dept of Agric NOP (National Organic Program: 7 CFR 205) regulates organic status in the US; organic certification requires an audit trail tracking all handlers from farm to distributor and requires materials to originate from an organism with a genome unaltered by modern biotechnology, and to be produced/processed without synthetic pesticides, synthetic fertilisers, irradiation etc.
n the EU, organic certification is regulated by Council Regulation 2092/91 EEC. Rules of Production from plants & plant products is set out under art. 6 annex 1; rules for inspection requirements from farms or collection (annex III, A).
[Cropwatch comments: We don’t deny that the principle behind the organic movement is not a worthy one. But a word of caution: "Certified Organic Essential Oils" are not necessarily always pesticide free, because of the phenomena of universal background pesticide levels/pesticide drift, and they are not usually analytically tested by certifying agencies to prove that they are in fact lower in, or free of, pesticides than non-organic produce. History shows that essential oils claiming to be "certified organic" have been shown to contain large amounts of diethyl phthalate on occasion in the UK – on 3 separate occasions which Cropwatch has come across, from the same (unscrupulous) producer!].
Packaging/other food contact materials: traceability etc.
EC Directive No. 1935/2004 art 17. & 24 (implementation date 27th Oct 2006) refers to systems & procedures for full traceability of materials & articles coming into contact with foods or food ingredients, extending the traceability regs. for food ingredients used in the food chain under EU Food Framework Reguln. 178/2002 art 18.). The purpose is for the identification of materials & article suppliers, for recall of defective products, consumer information & attribution of responsibility (art 17.1 of Reguln. 1935/2004).
Natural products must comply to Council Directives 76/895/EEC, 86/362/EEC, 86/363/EEC & 90/642/EEC and amendments for maximum levels of pesticides in or on foodstuffs. Synthetic pesticides can be persistent in the environment as well as bio-accumulative, and can be broken down into several major categories e.g. oganochlorine compounds, organophosphates, dithiocarbamates etc. A pesticides data-base for essential oils has been started at http://www.cropwatch.org/pesticidesdbase.htm
Polyaromatic Hydrocarbons (PAH’s).
Polyaromatic hydrocarbons can arise in essential oils under dry distillation conditions. IFRA has previously given guidance for PAH containing oils (i.e. Cade oil crude from dry distillation of Juniperus oxycedrus should only be used in perfumery when redistilled to reduce/eliminate PAH content). Oils should not contain more than 1.0 ppb benzo(a)pyrene.
Polychlorinated Biphenyls (PCB’s).
These man-made persistent air & water-borne pollutants tend to bio-accumulate in plants & animals. Their manufacture & use in electrical equipment ceased in the UK in the 1970’s. The current TDI recommendation is 2pg WHO_TEQ kg. They are regulated in Holland under Article 2 of Food & Drug Contamination of Food and under Attachment 1 of 90/642/EG (see dioxin above).
A product specification to a given standard will generally be required. This could be an internal standard, or to the specifications of standardising organisations such as, FCC IV, EOA, ISO, AFNOR etc., or a stipulated Pharmacopoeia (e.g. Eu Pharm, USP, BP) etc.
Protection of Wild Flora & Fauna.
The aroma industry has a fairly shameful record in this area, and actually helps to eliminate threatened species, either through ignorance or greed e.g. the sale of Kenyan Cedarwood oil from Juniperus procera Endl. previously reduced the species to the edge of extinction, so that only a few miserable diseased specimens now remain. EC Regulation 228/97 and articles from 388/97 (the detailed rules for the latter being set out in Commission Regulation EC No 865/2006) effectively put in controls to protect species such as Indian & African Civet, Musk Deer, Costus, Mountain Tobacco and Gentian spp. – but this move has had little effect in preventing unmonitored European aroma companies trading these items. The sale of ambergris is legally prohibited in Australia and the US, but this did not prevent the flagship trade journal Perfumer & Flavourist speculating recently in its columns on who would purchase a recent large Australian find (!). The need for education on this topic was never more urgent, before other hard-pressed species like Sandalwood (Santalum album) and Rosewood (Aniba spp.) disappear altogether in the wild.
REACH (Registration, Evaluation, Authorisation of Chemicals).
All manufactured substances (including essential oils, botanically derived extracts etc.) either manufactured or brought into the EU produced at over 1 metric ton (1000Kg) will eventually need to conform to this regulation*, the final form of which is expected to be agreed in 2007. Registration of individual substances is expected in several waves according to volume (except for CMR materials) which will be followed by Chemical Safety Report submissions, risk assessments etc. etc. Costs to the European fragrance & flavour industry is expected to be in the hundreds of millions of UK pounds sterling, when reformulation & administrative expenses are included, although flavour substances are expected to be excluded. Animal welfare issues wrt extra demands of extra toxicological testing required to implement REACH are unresolved.
*That is, unless you happen to be a very powerful lobbying organisation. For example REACH may not apply to turpentine oil.
In contrast it might be of interest to note on the other hand that the US-American High Production Volume (HPV) program initiated in 1999 has effectively come to nothing.
Information requested may include:
AIC listed? (Australian Inventory of Chemical Substances)
Chemical name according to IUPAC:
CAS #’s (Chemical Abstract Service #’s EU & US):
CAN Domestic Substances List (DSL) listing? [Cropwatch comments: nearly 400 flavour/fragrance ingredients are now delisted from the original list]
CoE # (now replaced by Flavis #)
Commodity Code # - Country of origin & Harmonised Tariff Codes (HTC),
NAFTA information may be required.
EINECS # (q.v.)
Flavis # (q.v.)
IFRA accordance statement (q.v.).
JEFCA # - see http://apps3fao.org/jefca/flavoagents/flavag-q.jsp.
MITI listed? (Ministry of International Trade & Industry Japan).
RIFM Monograph #
TSCA Inventory inclusion? [Number may be required under US Environmental
Protection Agency’s TSCA Inventory].
[Cropwatch comments: ISO standard No. 21092 lists CAS, EINECS, FEMA, EC & FDA Nos. for essential oils].
The carcinogenic Sudan dyes I, II, III & Scarlet Red/Sudan IV continue to be found in food products such as chilli, canned food, pizza, sauces & dips etc. and the EC last year (2005) extended EC import controls to include curcuma and virgin palm oil. These dyes are not considered safe in food at any level and essential oil/vegetable oil/spice suppliers may be required to prove their absence in their natural botanically derived products.
Suitability for Cosmetics.
IFRA standards – see above .
Allergens etc. in Cosmetics Directive III/1 refs 67-92 (N.B. this list includes benzyl alcohol).
Traceability of product lots may require conformation to article No 18 of EC Regulation 178-2002.
Products may be required to have their status declared with regard to whether they contain animal or animal-derived ingredients (such as tallow & tallow derivatives), or whether they have been processed with animal or animal-derived ingredients. They may need to be completely free of Specified Risk Material according to 98/16/EC, and appropriate processing conditions met. Suppliers may also be asked whether products contain protein banned under EU Council Decision 2000/766/EC (4th Dec 2000) concerning protection measures wrt transmissible TSE/BSE and the feeding of animal protein.
This will often approach 100% for several essential oils; cold expressed citrus oils, rose oils, ginger oils etc. will have a non-volatile content due to the presence of waxes/stearoptenes, furanocoumarins etc.
DH 2004: see http://horizonscanning.defra.gov.uk/Default.aspx?menu=menu&module=Programme0205&NavID=29.
Walden J. & Holton E. “Organic Certification” Perf. & Frag. 30 June 2005 pp12-15.
Taylor E. & Taylor Z.T. (2004) “Perceptions of the bureaucratic nightmare” of HACCP.” British Food Journal 106(1), 65-72.
V.D. Zheljazkov, E.A. Jeliazkova, L.E. Craker, B. Yankov, T. Georgieva, T. Kolev, N. Kovatcheva, S. Stanev, A. Margina (undated) “Heavy Metal Uptake in Mint.” ISHS Acta Horticulturae 500: II WOCMAP Congress Medicinal and Aromatic Plants, Part 1: Biological Resources, Sustainable Use, Conservation and Ethnobotany.
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