Creosote Stakeholder Consultation
Introduction 
In the course of the Review Programme for existing substances used in biocidal products, the Rapporteur Member State for the evaluation of creosote reached the following conclusion in its Competent Authority Report submitted in October 2007:
'Based on the hazard assessment and risk characterisation for human health, an inclusion in Annex I of Directive 98/8/EC cannot be recommended at present for creosote as an active substance in wood preservatives, product type 8.'
Recently, new data on dermal absorption and exposure, produced according to available OECD guidelines and the EU Guidance document on dermal absorption, has been submitted by the applicant. Based on these new data, a safe use of creosote may be able to be identified with regard to human health. Therefore the recommendation in the report might be revised in order to propose inclusion in the Annex to the Directive.
However, the environmental risk characterisation section of the Competent Authority Report demonstrates that there are risks identified for some in-service uses for creosote treated wood. Based on the data presently available it has been shown that there are risks when treated wood is used in use classes 4 and 5, i.e. wood in direct contact with soil or water (freshwater and sea water).
If it should be decided that creosote cannot be included in Annex I or included with restrictions, the use of biocidal products containing creosote could eventually be prohibited and these products would have to be removed from the EU market.
However, the Rapporteur Member State also suggested that benefits from the use of wood preservatives containing creosote should be considered before taking a final decision:
'It is also recommended that the benefits of creosote products are analysed before a final decision is taken.''
During the 27th and 28th meetings of the Competent Authority for the implementation of Directive 98/8/EC, Member States discussed and agreed on the need to perform an overall risk/benefit analysis before taking a final decision.
Background
Directive 98/8/EC of the European Parliament and of the Council on the placing on the market of biocidal products was adopted in 1998 and entered into force on 14 May 2000.
The Biocidal Products Directive (the Directive) aims to harmonise the European market for biocidal products and their active substances. At the same time it intends to provide for a high level of protection for humans, animals and the environment.
The scope of the Directive covers 23 different product types. These include disinfectants used in different areas, non-agricultural pesticides, anti-fouling products used on hulls of vessels and chemicals used for preservation of products and materials, such as wood preservatives (product type 8), to which creosote belongs to.
Furthermore the Directive establishes a Review Programme for the systematic evaluation of those active substances, which were already placed on the market when the Directive came into force (the so-called existing active substances).
At the end of their evaluation, those substances, which are found to meet the requirements of the Directive, are included in Annex I or IA of the Directive and can be used in biocidal products, subject to the authorisation of these products by the Member States. Those substances, which do not meet the requirements of the Directive, are not included in the Annexes of the Directive and can no longer be used in biocidal products.
Issue
Creosote [CAS No. 8001-58-9], as defined in the European Standard EN 12303 (CEN 2000), is a brownish-black oily liquid with a smoky odour. It is a distillation product of coal tar which itself is a by-product of the high-temperature destructive distillation of bituminous coal to form coke.
The distillation process generally produces several oil cuts starting from 80°C to 450°C. Creosote is the intermediate cut, ranging from 200 to 355°C as described in the European Standard EN 13991 (CEN 2003).
Creosote is a complex mixture of hundreds of distinct compounds, including bi- and polycyclic aromatic hydrocarbons, phenols, as well as heterocyclic, oxygen-, sulphur- and nitrogen-containing compounds.
The application of creosote is industrial preventative wood treatment. During decades creosote treated wood has been used in several applications.
Two grades of creosote oils are presently under evaluation. The common one is called Grade B and is intended for treatment of timber wood by pressure impregnation. Grade C excludes the lower boiling fraction allowable in Grade B, and because of the lower volatility a reduction in odour is achieved.
Nevertheless, creosote has been restricted to some extent by Directive 76/769/EEC relating to restrictions on the marketing and use of certain dangerous substances and preparations because of its demonstrated hazardous properties.
Creosoted wooden sleepers are widely used by railway companies, especially in rural areas or in places which are difficult to reach. Also well known are the wooden poles utilized for the distribution of electricity or telecommunication wires. Last but not least, agricultural and industrial fencing is a big market for creosoted wood.
Consultation
In order to perform an overall risk/benefit analysis of the use of creosote as a wood preservative, the Commission services are inviting stakeholders to comment on the possible consequences of the inclusion or non-inclusion of creosote in Annex I to Directive 98/8/EC. In particular, the Commission services would invite stakeholders to provide sound data or evidence on:
- The practical and economic consequences of the phasing out of creosote.
- The availability of less hazardous or non-hazardous alternatives to creosote or creosote treated wood.
- Advantages and/or disadvantages of the use of these possible alternatives compared to creosote or creosote treated wood.
- Practicability of these possible alternatives, in particular whether they can be used in large industrial and/or commercial scale.
- If alternatives are not yet available, estimate of the time needed to develop and make available sound alternatives to the use of creosote.
- Whether or not alternatives can be used in connection with maintenance of cultural heritage or protected constructions.
The consultation started on 30 April 2008 and was closed on 30 June 2008.
Contributions and the outcome have been published on the Commission website for biocides.
Useful link
First Draft Competent Authority Report |