Cropwatch
4.
OPINION:
The EU Biocidal Products Directive 98/8/EC and Essential Oils – The EU
Machinery Gets It Wrong Again!
§1. Alarm Bells Ring.
Poor
publicity surrounding the passing of the EU Biocidal Products Directive 98/8/EC
caught many in the EU commercial sector off-guard. For example an European
Federation of Essential Oils (EFEO) communication
(Nov 2003) drew attention of its members to yet another piece of legislation
potentially affecting the free & unfettered use of essential oils: “The EU
rules on biocidal products (EU Directive 98/8/EC, Regulation 1896/2000/EC) and
the follow up piece of legislation OJ L 307 of 24th November 2003,
accessed via http://europa.eu.int/eur-lex/en/oj/index_20031124.html,
means that under Annex III , and as
far as we can understand the situation at present, the following oils - subject
to clarification - cannot be used in the Community Market as Biocides
after 1st September 2006*:
Basil
oil, Cajuput oil, Cedarwood oil, Celery oil, Chamomile oil, Citronella oil,
Clove leaf oil, Coriander oil, Cornmint oil, Cumin oil, Cypress oil, Eucalyptus
oil, Juniperberry oil, Neem oil, Pinus oils, Lavender oil,
Lemongrass oil, Geranium oil, Litsea cubeba oil, Melaleuca oil,
Pine oil, Black pepper oil, Palmarosa oil, Patchouli oil, Pennyroyal oil,
Peppermint oil, Rosewood oil, Rue oil, Spearmint oil, Thyme oil, Valeriana
officinalis oil, and many, many other natural oils or natural
extracts.”
*The information in this 2003 communication may have
subsequently been updated - please
check the appropriate websites.
§2. Preamble: Biocides and Legislation: a
Potted History
The
EU Biocidal Products Directive (BPD), is aimed at harmonising the EU internal
market for biocides, affording a high level of human, animal & environmental
protection, being adopted by the European Parliament in April 1998; member
states were supposed to transpose the rules of this into national law by 14 May
2000. Biocides are products that destroy, deter or render harmless, harmful organisms
by chemical or biological means, or otherwise control or prevent their action.
The BPD covers similar product types to the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) in the US.
The
model for the BPD was the Plant
Protection Products Directive 91/414/EEC
(PPPD), which came into force in July 1993, aiming at harmonising regulatory
information. Here, active substances used in PPP’s were individually evaluated
and a dossier is constructed containing all the safety studies for the active
substance(s), as defined by the directive. Approved substances, are then listed
in annex I. A 12-year review process was begun, intending to evaluate all active
substances by July 2003; PP’Ps. Fees paid by producers wanting to support an
individual PPP were in excess of £125,000 (British Pounds). A guidance document
for borderline products between the BPD and the PPPD is available at http://ecb.jrc.it/biocides/
Returning
to the BPD – the directive describes four main groups of products, divided
into 23 categories of biocidal product types which fall within the remit of the
Directive – this is extremely wide-ranging and can be viewed at http://ecb.jrc.it/biocides
by clicking on 'Directive 98/8/EC’, but
for convenience these categories are set out below:
MAIN GROUP 1: Disinfectants and general
biocidal products
Product-type 1: Human hygiene biocidal products
Product-type 2: Private area and public health area disinfectants and other
biocidal products
Product-type 3: Veterinary hygiene biocidal products
Product-type 4: Food and feed area disinfectants
Product-type 5: Drinking water disinfectants
MAIN GROUP 2: Preservatives
Product-type 6: In-can preservatives
Product-type 7: Film preservatives
Product-type 8: Wood preservatives
Product-type 9: Fibre, leather, rubber and polymerised materials preservatives
Product-type 10: Masonry preservatives
Product-type 11: Preservatives for liquid-cooling and processing systems
Product-type 12: Slimicides
Product-type 13: Metalworking-fluid preservatives
MAIN GROUP 3: Pest control
Product-type 14: Rodenticides
Product-type 15: Avicides
Product-type 16: Molluscicides
Product-type 17: Piscicides
Product-type 18: Insecticides, acaricides and products to control other
arthropods
Product-type 19: Repellents and attractants
MAIN GROUP 4: Other biocidal products
Product-type 20: Preservatives for food or feedstocks
Product-type 21: Antifouling products
Product-type 22: Embalming and taxidermist fluids
Product-type 23: Control of other vertebrates
Substances
deemed “suitable” for use in biocidal products are set out in Annex I of the
BPD - the European Chemicals Bureau produced an initial non-exhaustive list of
active substances. Individual commercial products containing these substances
will require authorisation under the Directive within Member States.
If proponents wish to support a substance through a review process under
the Directive, then they have had to 'notify' the active substance to the
European Chemicals Bureau, indicating biocidal product type they wanted to
support the active for. If proponents did not want to support the
substance through a review then there was the option to 'identify' the active
substance. The lists of notified and identified active substances are available
in the Second Review Regulation. Annex I of the Second Review Regulation
contains the list of existing active substances which have been identified, and
Annex II of the Second Review Regulation contains the list of existing active
substances which have been notified. This can be found at:
http://europa.eu.int/eur-lex/pri/en/oj/dat/2003/l_307/l_30720031124en00010096.pdf
Three possibilities emerge:
1. For
active substances that have been notified, products containing them can continue to be placed onto the
market
subject to any requirements under existing national legislation, until the review has been completed. If the
substance is successful in gaining listing on Annex I, then products containing it will need to be authorised under the Directive in Member
States. Once authorised, any approvals given under older national schemes will lapse. If the substance does not gain Annex I listing then products
containing it will have to be removed from the market.
2. If an active substance has been identified but not notified, or
notified but not for the product types in which products are marketed, such products
can continue to be placed on the market, subject to any existing national
rules, until 1 September 2006.
3. If an active substance has been neither identified nor notified, then products containing that active substance can no longer be legally placed
on the EU market after 14 December 2003 (i.e. the date that the
Second Review Regulation entered into force).
Although many low risk biocidal products may not have
needed supporting, Knight (2000) gives details showing the estimated the cost of
supporting an active substance through a BPD review at the time as £1.48
million and for the whole EU program of active substances as £370 million.
Other estimates included one of 3 million Єuros ($2.6 million) price tag for each active
ingredient in cosmetics formulations should they not be exempt (Scott 2002).
Basically this has meant that large concerns such as Rohm and Haas, BASF, and
Lonza were capable of supporting their biocidal product range, whereas many
small producers closed down or were acquired by competitors.
A list of biocidally active chemicals where restrictions of marketing and use applies under Directive 76/769/EEC includes:
· Arsenic (Directive
2003/2/EC)
·
Creosote (Directive
2001/90/EC)
·
Organic tin compounds (Directive
2002/62/EC)
·
Mercury (Directive
89/677/EEC)
·
Pentachlorophenol (Directive
1999/51/EC).
Failure of eleven
national governments to transpose the EC commisions 1998 BPD into national law
or failing to adopt certain measures to its dangerous substances directive, has
resulted in a series of legal threats against Luxembourg, Austria, Germany, Greece, Luxembourg, the U.K. etc. and legal action against France by the European Commission in the
European Court of Justice (Brown, 2001; European Report 2003, York 2002).
The biocides market is
mature, growing at some 5% per annum. Freedonia Group (2000) predicted that the
US demand for biocides would reach $2.2 billion in 2004 with halogenated
products (chloroisocyanurates,
iodophors etc. – used in water treatment) constituting the largest group.
§3. Some Aspects of
the After-Effects of the BPD.
It
is impossible within a short space to set out the full implications of the
legislation on the EU commercial sector, and indeed on EU citizens, but here
below are a few considerations:
Pesticides: Scott
(2002) predicted that there would be an 80% reduction in the number of biocides
available in the commercial market, removing small tonnage active products for
niche markets, and letting in products which were non-specific for the task and
which had to be applied in larger volumes. The deep misgivings of learned horticultural experts with
respect to the effects of the incoming legislation were widely reported in the
UK daily press. Pook (2002), reported a statement by the Royal Horticulture
Society that “many well-known garden chemicals would disappear not because of
safety but because of the high cost of gaining approval for sales in a
relatively small market EU ruling will cut range of pesticides”. Elsewhere in
the article Pook predicts that the number of approved substances would drop from
800 to 300. Other press criticism included remarks in Metro July 30 2002
concerning risk of the rise of resistant super-pests, prompting Prof. Paul
Jepson to speculate that “public pressure might change once the production of
a range of crops is no longer sustainable”. By July 8th 2003, the
Guardian (p8) predicted chaos as lawnfeed and weedkiller products sold by large
UK stores were banned by an unpublicised European directive, and
had to be disposed by local authorities whose local councils were unaware of
their new responsibilities.
“Safe
biocides” is of course a relative term - weedkillers used in farming being
washed into rivers and carried down to were blamed for erosion of salt-marshes
threatening the coastal defences in the SE of England according to Prof Chris
Mason of Essex University as reported by Geraint Smith Evening Standard
23 June 2003 p18. Even The Times reported that superbugs threaten our
potatoes and carrots (Times Tues July 30th 2002 p7) quoting
Professor Ian Chute of Rothampstead, who said that “it is certainly quite
possible that a combination of resistant insects and removal of insecticides
through regulation could leave us vulnerable to a situation where we would have
to bring these articles in from abroad”.
Niche
applications of natural products (e.g. garlic vegetable processing waste used
against aphids in the cut flower industry; various essential oil-water-natural
surfactant emulsions against rust in vegetable & herb crops) are known in
the essential oil trade; these applications tend to be minor use “trade
secrets”.
Food
trade. Campden
& Chorley Wood (Anon 2003) wrote a brief piece reporting on the significant
costs to disinfectant manufacturers caused by the requirements of the BPD,
additionally noting that currently there is no requirement for disinfectants to
be approved for use in the UK, and that the responsibility to provide assurances
on efficacy was down to the producer. But they also noted that the European Standards Organisation (CEN) have produced new
disinfectant test methods which are published by the British Standards
Institute, the methods including disinfectant use throughout the food chain,
including efficacy against bacteria and their spores, fungi and viruses.
Cosmetics Industry & Biocides
Dweck (SPC 2003) subtitled his paper to the SCS Symposium
2003 as “The Reality of the Futility of Natural Preservatives”,
pointing out the hoops that have to be jumped through for a natural material to
attain natural cosmetic preservative status. Thus the prospective ingredient
would have to appear in Annex VI Part 1 of 2 of the EEC Cosmetic Directive
76/768/EEC, including the 7th amending Commission Directive 94/32/EC, have a
beneficial effect on the skin and have a positive effect on the total
preservative requirement of the formulation, if it is declared as a natural
active as ‘a parfum’. Notwithstanding, Dweck goes on to list the potential
antimicrobial activity of a huge range of plants and extracts.
Earlier David Roper (Manufacturing Chemist 1996)
had suggested that reliance on preservatives in cosmetics might be reduced via
formulation strategies such as adding salt or glucose; maintaining pH levels at
5.5; using metal ions such as silver, or using natural antibiotics such as neem
tree seeds, herbs, spices and terpenes.
These two examples confirm the position of certain natural aromatic products as being biocides by technical experts working in the field.
The Aromatherapy
position wrt Biocides: Previously Sylvia Baker of the Aromatherapy Trades
Council (currently representing some 53 essential oil distributors) produced an
information sheet together with Phillip Clarke of the Health & Safety
Executive in Dec 1998 which explored the position of the BPD and the practice of
aromatherapy. At the time it was expected that essential oils used in UK
practice would appear to fall under the scope of the Medicines Act 1968 and
would not be affected by the BPD. Creams, lotions and massage oils were expected
to fall within the Cosmetic Products (Safety) Regulations and again not be
affected by the BPD. An appeal to ATC members to list essential oils used as
insect repellents was made in Jan 1999 so that the could be included in a BPD
positive listing and remain on the market after May 2000. A Nov. 2003
legislation udate by the ATC at http://www.a-t-c.org.uk/pages/index.cfm?FuseAction=ShowPage&sec=6&page=190
states: “These Regulations
are likely to only affect those aromatherapy companies that produce products
whose prime function is that of insect repellents rather than cosmetics”.
Essential Oils Trade.
The
essential oils supply industry has already been under pressure from intolerable
demands for documentation and EU red tape with respect to 7th
Amendment to the Cosmetics Act (26 allergens issue), Transport & Packaging
regulations, GMO certification, foodstuffs regulations (naturalness
certification, heavy metal content, pesticide levels, PCB’s levels, dioxin
levels) etc. etc. and many oil traders have disappeared altogether or have been
taken over by larger concerns. In spite of the efforts of bodies like European
Flavours & Fragrances Association, many oil traders are still completely
unaware of the BPD, or in the current state of low morale, regard it as another
just nail in the coffin for the industry. The opening communiqué from EFEO
above in §1 gives a flavour of a harassed and overstretched industry trying to
cope with increasing demands for paperwork which detract from its’ core
activity of producing & trading essential oils.
Perfumery Trade.
In today’s marketplace, fragrances are often expected
to possess beneficial properties apart from merely possessing a pleasant odour -
mood changing perfumes, for example, are now quite commonplace. Biocidal
perfumes have been with us for a long time – in fact a forty-year-old article
on the properties of Eau de Colognes (Rovesti P. 1961) explores & celebrates
this very concept. Nevertheless, it would seem that this area needs to be better
explored, in order not to suppress potential commercial applications.
Insecticidal Use.
A number of small UK companies use formulations
containing essential oils as insect repellents for human and animal use (horses,
dogs, cats etc.); a literature review of these applications is currently in
preparation by the author. Most of these companies contacted by the author in
2003-4 were unaware of the BPD.
In a private letter to the BPU (Dec 2003), the author
pointed out that one of the principle anti-malarial drugs (artemisinin) is
derived from the extract/essential oil of the plant Artemisia annua, extensively
used in Chinese medicine for over a thousand years as an anti-malarial (Trig
1989) – which does not figure in the BPD Annexes. This litmus test failure
shows that leaving the construction of an exhaustive list of biocides to
industrial input has been largely unsuccessful (this being just one example of
many).
§4. Comments.
General Remarks
Why draw attention to the Biocides issue? It is important
because the EU citizen’s right to use natural products is being continually
eroded, often by legislation which is seen by some outside experts to be highly
contentious or distinctly in favour of Corporate interests. It isn’t a great
step to empathise with ‘conspiracy theory’ supporters who suspect that the
power and influence of large chemical and pharmaceutical concerns (via lobbying
in Brussels etc.), is actually influencing and distorting the proper and fair
process of EU law-making, and affecting the free choice and human rights of the
EU buying public to buy natural products.
Essential oils as biocides.
A literature search will reveal whole libraries-worth of
material supporting the traditional multi-faceted global role of essential oils
and other aromatic products as biocides – for elimination of food crop pests,
for their human topical anti-fungal properties, for actions against human
bacterial pathogens, their uses in vetinary applications against parasitic
infestations, and as disinfectants and preservatives as well as uses as insect
repellents and attractants.
To quote a couple of examples, the use of essential oils
as an alternative to methyl bromide fumigation for food crop produce was the
subject of an article by Landau (1999), and the death kinetics of Staphylococcus
aureus bacteria to tea tree oils was reported by Christof et al. (2001).
How can it be then that the existing EU legislation is in denial over
these properties, seeking to cover up biocidal properties by filing away natural
products in other pieces of legislation – such as General Medicines Act, or by
regarding them as cosmetics. Scientifically, essential oils are biocides –
it’s an irrefutable fact. Why then do we have to tolerate pieces of EU
legislation such as the BPD, which requires an impossibly large input of effort
by non-EU officials, in order to give EU legislators concerned an exhaustive
positive list of biocides which includes natural products?
Well that’s not strictly true, they would argue.
Whereas you could be forgiven for assuming that the BPD had been drawn up 100%
exclusively by input from the synthetic chemical industry [indeed the standard
text book on the Biocides Business (Knight & Cooke 2002) - does not
even mention essential oils!]
defenders of the existing legislation (if there are any) would point to
Annex 1 of the Directive, where some essential oils have been listed. The
problem is, with so many possible potentially biocidal essential oils – who
exactly has time to list them all (basically for zero potential reward)? And why
aren’t they listed there for potential use as a block category, by a competent
EU official?
EU legislators would argue that those with vested
interests in using essential oils in retailed products specifically for a
biocidal purpose would be the people to have registered the oils in Annex 1. But
the real answer is of course that the situation is driven by economics. “Big
Industry” cannot generally make serious amounts of money out of marketing
applications of commonly used essential oils as biocides – as their
applications are often enshrined in traditional use, and therefore the
applications are prospectively not covered by patents. Conversely small
retailers of biocidal products, who might benefit from niche applications, are
unlikely to be able to afford the enormous prospective costs of the complete
registration process with their slender economic resources, and so are prevented
from pursuing their legitimate commercial interests. Clearly an uneven playing
field discriminating against small concerns, created by the requirements and
procedures of the EU directive itself.
Anne Ashton (2004) has advised that a Niche Market
Working Group has been set up by the EU Commission to investigate and take
forward the issue of low volume/niche market uses of biocides – however the
problem is one of identification & notification of interested parties who
may not belong to trade associations or other concerned groups.
2. Safety issues
The fact that the world is not yet a healthier place in
spite of the commencement of the Chemicals Policy of the EU has been the subject
of recent press comment, as for example the frequency of the incidence of
cancers continues to rise (including breast cancer: Ruddell 2003; Hodgekins
lymphoma, prostate & testicular cancer & multiple myeloma: Page 2004),
and asthma attacks and allergies reach alarming levels Europe-wide. This was a
stated reason why the Chemicals Policy was introduced in the first place (see:
http://europa.eu.int/eur-lex/en/com/wpr/2001/com2001_0088en01.pdf).
Whilst it could and probably should be argued that it is early days for
this policy just yet, the effects of the legislation may well lead to human body
loading of higher amounts of “safe” synthetic chemicals with unknown
prospects for human health over the long term.
Another negative aspect of the BPD legislation is the
fact that as well as the requirement to register actives, risk assessments will
have be carried out in relation to human health and the environment, whilst
efficacy will also be valuated. Ann Ashton notes (2004) “It was not the
EU Commission or the Competent Authority's responsibility to ensure all actives
are listed, but Industries’ responsibility to choose which actives they wished
to list” (presumably therefore only the profitable ones will be listed). This,
to my mind, thoroughly mis-comprehends the expected role of industry in this
matter by the BPU. The fact that there is no actual industrial economic
incentive to list natural actives has been already dealt with above. But more
seriously, the fact is that the safety of essential oils is already thoroughly
reviewed & established elsewhere, and it seems stupid to reinvent the wheel
for this essentially specious purpose here. In any case, many aspects of safety
of essential oils are, however, quite contentious: the 26 allergens issue
(within the 7th Amendment to the EU Cosmetic Act) is considered by
many in the aroma trade a thoroughly bad piece of legislation based on shaky
scientific evidence generated by identifiable dermatologists with vested
professional interests and an obviously poor comprehension of aromatic &
terpene chemistry. Curiously the
Act has been passed (perhaps, it could be cynically argued, that it came along
at a convenient point to be fitted within the scope and aims of the EU Chemicals
Policy), in spite of the accumulation of scientific evidence suggesting the
science behind listing of certain substances within the 26 allergens list is
patently incorrect (for example in the cases of linalool, coumarin, benzyl
salicylate etc). This particular piece of legislation has had a negative effect
on the overall volumes of natural essential oils incorporated into cosmetic
formulations as fragrance components in the past year or two, letting in
Corporate Aroma companies with the resources to produce “safe” synthetic
molecules, and driving us evermore towards a synthetic perfumery future. The art
of natural perfumery – and hence the rights of consumers to avoid un-natural
synthetic aroma chemicals - has been made almost impossibly difficult to work by
this divisive legislation.
The requirement to demonstrate efficacy of the
“identified actives” in the BPD – reveals even more evidence of the
synthetic chemical lobby’s influence in the very wording of the legislation.
“Identified actives” in essential oils are 100% of the contents of the oil,
because of the symbiotic biocidal activities of the individual components making
up the oil. Whereas essential oils are distinctly useful as biocides, they may
not be sufficiently wide-spectrum in their range of actions, may not have rapid
kill times, and their minimum inhibitory concentration values may not be in the
same range as chemical disinfectants. Does this mean they should be excluded
from the definition of disinfectant just because their mode of action is not
widely appreciated or not fully elucidated? The range of mechanisms displayed by
essential oils for bacterial kill (for example Knobloch et al. 1987 suggested
terpenoids inhibit electron transport, proton translocation, phophorylation
steps and other enzymic reactions within the cell) surely means that they
justify occupying a separate category of biocides all on their own? In
particular cell mortality via potassium ion leakage has been established as a
mode of action by tea tree oil (Melaleuca alternifolia) against E.
coli and Staph. aureus by Cox et al. (2000), although other workers
have explored other possible modes of action (i.e. Carson 2002); these may prove
useful in fighting drug-resistant human pathogenic fungi etc. such as Candida
albicans (see Mondello F. et al. 2003). It seems that purely commercially
orientated definitions of active components, disinfectants, antiseptics etc. is
going to lead to the distorted world of corporate science, which has little
relationship to the absolute of pure science and truth.
3. A (past) glimmer of hope? - Essential and Minor
Use Products.
If you go to http://www.hse.gov.uk/hthdir/noframes/biofact11.htm
you will see that under the heading of Essential and Minor Use Products:
“At a meeting of the competent authorities in Dec 2001,
there was some discussion about the difficulties some Industries may have in
supporting active substances that are considered to have minor or essential uses
as biocides. Essential oils, pheromones and Product Type 22 (embalming and
taxidermy fluids) were mentioned as examples. Whilst the EC is clear that there
are no derogations under BPD for such uses, it does appreciate that there may be
difficulties and that an alternative way forward may need to be found. With this
in mind, the advice the EC is giving is that active substances with uses such as
biocides should at least be identified before 28 March 2002. After this date the
EC would look at the issue again. The best option is still to notify in case it
is not possible to agree a different way forward.”
If this is indeed a way forward, it seems that not many
outside specific EC committees know of it.
4. Attempts at reform.
The following extract from a personal mail was sent to
the BPU in Dec 2003 by the author:
“The existing list of notifiable substances which you
referred me to at http://europa.eu.int/eur-lex/pri/en/oj/dat/2003/l_307/l_30720031124en00010096.pdf
is in great need of editing by someone with technical knowledge. For example, Clove oil is un-necessarily down twice, once under its unused
former Latin name. Cedar oil is down twice (as CAS No: 68890-83-0: Texas Cedarwood oil and 8000-29-7: Virginian Cedarwood oil, but this isn't made
clear) but none of the genuine cedarwood oils are listed [for example Atlas Cedar Cedrus atlantica, Himalayan Cedar Cedrus himalaya etc.].
This is unfortunate because Cedrus deodara is used in Indian to combat sheep
mange, and as a molluscicide. Does this non-listing mean that a farmer in the UK
who wants a natural preventative to combat sheep mange in his flock cannot use
the oil of Cedrus deodara after September 2006?
Really the list of actives is not a defining document, does not include Latin names, chemotypes or geographic origins of essential oils which are
universally recognised as being required to properly define them, and mixes US
and EU listings of CAS numbers. Further, the comprehensive listing (as claimed)
of all uses of essential oils used as Biocides is probably not technically
possible as I indicated earlier unless expert input is employed, and is
especially not attainable in a short timescale, by merely relying on inputs of busy technical departments of those manufacturers who are aware of the
regulations.”
At the time of writing (31.05.04), many of the EU
internet links on Biocides are not working, so any subsequent reforms made to
overall scientific accuracy of the information currently presented cannot be
checked out
§5. Concluding Thoughts.
As we have seen above, enactment of hasty and badly constructed EU legislation implementing aspects of the Chemicals Policy (such as the “26 allergens” issue & the BPD) has benefited the large industrial concerns and has caused the collapse and acquisition of many smaller EU companies unable to financially support their products. In certain cases currently known to the author, large Corporations are just waiting for the biocidal product patents of small concerns to expire, or for the companies to bleed to death financially because of BPD requirements, before jumping in and patenting the products for themselves. In this respect the EU is certainly living up to its reputation as “a rich mans club” and is actively discriminating against small concerns by setting them impossible conditions for the continuance of business.
The frightening aspect of the BPD legislation, as with
other aspects of EU bureaucracy, is the sheer impotence of the European citizen
or small craft industry in being able to make the slightest difference the
eventual outcome of any due EU legislative process. The European citizen has
been effectively disenfranchised by a Brussels mindset which prefers to deal
exclusively with professional organisations and industrial representatives.
In practical terms, notifying a completely exhaustive list
of essential oils with biocidal properties to Annex 1 might theoretically take
an ethno-botanist with a team of helpers a year or so to complete – adding
safety information (where available) might take a lifetime. In any case much
safety information on essential oils used in perfumery and flavourings is
already available, and some of these same assessed oils are also used for
biocidal purposes. So why exactly should we EU citizens be denied the potential
use of essential oils as biocides in the future, because inappropriately
experienced officials in the EU with no authoritative overview for this area
want a positive list? Essential oils are already used in many hospital and
health care situations – and so the sheer absurdity of this measure coming so
quickly after the “26 allergens” fiasco, can only sour the relationship
between an aroma industry overworked with red tape, and - in the author’s
judgement, the whims of a somewhat under-performing and misdirected Health and
Safety officialdom.
§6. Recommendations.
1. That essential oils as class of biocides be treated as a special case.
2. That essential oils should be enabled to classified as the disinfectants and antiseptics that they undoubtedly are.
3. That all essential oils should be classed as potential biocides per se in the BPD, and not shunted off into other categories with secondary biocidal properties appended (such as cosmetics).
4. That toxicological evidence and matters surrounding the safe use of essential oils as biocides be adopted by reference to the experience and experimental studies of other user industries (perfumery, flavourings, pharmacology etc.).
5. That a referee is appointed within the EU Commission to review and amend existing legislation, in order to prevent “Corporate and Vested- Interest Science” ever again distorting the basis of absolute scientific truth required for EU legal processes.
6.
That the fundamental right to free choice for EU citizens in being able
to purchase commercially retailed items containing ecologically sound natural
products rather than synthetic chemicals be addressed by the EU.
References:
Anon (2003)
“CCFRA can help with disinfectant choice” Food Trade Review 5/1/2003
Ann
Ashton, BPU (2004) – personal communication
Brown
J. (2001) “Brussels Threatens Action over Biocide Directive” Chemical
Week 2/28/2001.
Carson CF et al. (2002) “Mechanism of action of Melaleuca
alternifolia (tea tree oil) on Staphylococcus aureus determined by
time-kill, lysis, leakage, and salkt tolerance assays and electron microscopy”
Antimicrob. Agents Chemother. 46(6), 1914-20.
Christof F., Stahl-Biskup E. & Kaulfers P.-M. “Death Kinetics
of Staphylococcus aureus exposed to commercial Tea-Tree oils s.l.” J. Essen
Oil Res. 13, 98-102 (Mar/April 2001).
Christy (1992) quoted by Kiesche,
Elizabeth S. “Regulations create a hairy environment for biocides” Chemical
Week 7/22/1992.
Cox SD et al.
(2000) “The mode of action of the essential oil of Melaleuca alternifolia”
J Applied Microbiol 88(1), 170-175.
European
Report 1/21/2003:
Environment: Luxembourg warned over pesticide legislation.
Freedonia Group (2000) Research
studies - Biocides Freedonia Group Inc Cleveland, Ohio.
Konbloch K. et al (1988)
“ Mode of Action of Essential Oil Components on Whole Cells of Bacteria” Bioflavour
1988 pp287-299.
Knight Derek J. and Cooke
Mel (2002) The
Biocides Business - Regulation, Safety & Applications
ed. by pub. Wiley-VCH 2002 ISBN 3-527-30366-9.
Knight Derek J.
(2000) “Active Control for Biocides” Chemistry and Industry 8/7/2000.
Landau P.
(1999) “Essential oils prove natural substitute for methyl bromide” Chemical
Market Reporter 3/22/1999.
Manufacturing
Chemist (1997)
“Preventing Microbial Contamination” Manufacturing Chemist 2/1/1997.
Mondello F. et al. (2003)
“In vitro and in vivo of tea tree oil against azole-susceptible
and –resistant human pathogenic yeasts” J Antimicrob Chemother. 51(5),
1223-9.
Morrison S.
(2002) “Biocides rule confuses suppliers to cosmetics sector” Chemical
Week 3/20/2002.
Page J. (2004) letter to The
Guardian 28th May 2004 p27.
Pook S. (2002) The
Guardian 16th
Sept 2002 p7.
Rovesti P. (1961)
“Aromatherapy and the Antiseptic Properties of Eau de Cologne”
International Commemorative Symposium on
Eau de Cologne SPC Year Book 1961
pp. 7-9 & 16.
Ruddell R (2003)
“Environmental Pollutants & Breast Cancer” Environmental Health
Perspectives June 2003.
Scott A (2002)
“Group fears EU policy may decimate industry” Chemical Week 10/30/2002
SPC (2003)
“Prevention & Cure: Cosmetic micro-biology – reducing your growth
potential” SCS Symposium 12-13th May 2003 Soap, Perfumery &
Cosmetics Sept 2003.
Trig P.I.
(1989) Qinghaosu (Artemisinin) as an Antimalarial Drug Ch 2 in
Economic & Medicinal Plant Research Vol 3 Academic Press 1989
Young I. (2002) “Brussels
takes France to court over Biocides” Chemical Week
3/6/2002.