The Cropwatch Series

Synopsis: This article takes fresh look at The EU Biocidal Products Directive 98/8/EC, which has met considerable criticism & condemnation by industry & academia alike. In particular it investigates the effect on the essential oil trade & natural products trades and their end-user customers, suggesting that basic & immediate reform of the legislation is necessary.

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 24^th 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.

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:

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

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

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

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

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:

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.

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 8^th 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 30^th 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.

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.atc.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”.

The essential oils supply industry has already been under pressure from intolerable demands for documentation and EU red tape with respect to 7^th 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.

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.

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).

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.

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.

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 7^th 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.

“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.

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

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.

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.