1999/833/EC: Commission Decision of 26 October 1999 on the national provisions notified by the Federal Republic of Germany concerning the limitations of the marketing and use of creosote (notified under document number C(1999) 3425) (Text with EEA relevance) (Only the German text is authentic
22. 12. 1999 EN Official Journal of the European Communities L 329/43 COMMISSION DECISION of 26 October 1999 on the national provisions notified by the Federal Republic of Germany concerning the limitations of the marketing and use of creosote (notified under document number C(1999) 3425) (Only the German text is authentic) (Text with EEA relevance) (1999/833/EC) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, and in particular Article 95(6) thereof, 3 % (= 30 g/kg) by mass. Wood treated with creosote or preparations containing creosote not respecting those limits may not be placed on the market. Whereas: I. FACTS 1. Community legislation: Directive 94/60/EC of laws, regulations (1) Council Directive 76/769/EEC of 27 July 1976 on the approximation and the administrative provisions of the Member States relating to restrictions on the marketing and use of certain last dangerous amended by Directive 1999/77/EC (2), provides for the prohibition and restriction of certain dangerous preparations. Directive and 76/769/EEC is regularly amended to include in its Annex additional substances which are dangerous to man and the environment. and preparations (1), the use of substances substances as (2) European Parliament and Council Directive 94/60/EC (3), which amends Directive 76/769/EEC for the 14th time, harmonises among other things the use and marketing of creosote and similar coal tar distillates, as well as preparations containing them, by limiting the content of in the one following B[a]P, and water extractable phenols when used for woodtreatment (point 32 in the Annex to Directive 94/60/EC). The limit for B[a]P is fixed at a maximum of 50 ppm (= 0,005 %) by mass and the limit for water extractable phenols is fixed at a maximum of component, Benzo-[a]-pyrene, specific (1) OJ L 262, 27. 9. 1976, p. 201. (2) OJ L 207, 6. 8. 1999, p. 18. (3) OJ L 365, 31. 12. 1994, p. 1 For use (3) However, by derogation, the Directive allows for the use of creosote and preparations containing creosote with up to 500 ppm (= 0,05 %) B[a]P by mass and water extractable phenols up to 30 g/kg for wood treatment in industrial installations. Such products may not be sold to the general public and containers have to be labelled with the phrase in industrial installations onlyí. Wood treated this way and placed on time can only be used in for the first the market industrial in applications, and professional except for example certain cases where its use is excluded, inside buildings, in contact with products intended for human or animal consumption, in playgrounds and in other outdoor places for public pleasure or where there is a risk of contact with skin. Old treated wood can be used commercialised for irrespective of the creosote-type applied except in the cases mentioned before. second time a 2. The German national provisions (4) The German legislation uses The German the term átar-oilsí to to the provisions in designate the substances subject question. Ordinance Tar-Oil (Teerölverordnung), which contains the national provisions concerning creosote, was notified to the Commission in 1990, promulgated on 5 June 1991, and entered into force on 1 October 1991. As part of the general the legislation on manufacturing, reorganisation of the Tar-Oil marketing, and use, Ordinance where included on 1 November 1993 in two ordinances, Ordinance (Chemikalien Verbotsverordnung, ChemVerbotsV) and the Hazardous Substances Ordinance (Gefahrstoffverordnung, the provisions of Chemicals Banned the L 329/44 EN Official Journal of the European Communities 22. 12. 1999 GefStoffV) without changing the substantive contents. The provisions of the two ordinances concerning tar-oils were amended by an ordinance of 19 Sepember 1994. (c) treated wood may not be used inside buildings or as a consumer product within the definitions of the Foodstuffs and consumer products Act (e. g. food packaging, hygiene products, and toys). (5) The term átar-oilsí are produced as liquid by-products of the coking of coal or wood, including those designated by the term ácreosoteí. substances covers that all (6) The legislation with regards to tar-oils in Germany is now comprised of: - provisions relating to the placing on the market, incorporated into the Banned Chemicals Ordinance in section 17 of the Appendix to paragraph 1, - provisions relating to special labelling requirements, incorporated Substances Ordinance in paragraph 12 in conjunction with Appendix III, No 15, the Hazardous into - provisions relating into and use, Substances incorporated Ordinance in paragraph 15 in conjunction with Appendix IV, No 13. to production the Hazardous (7) In principle, the German regulations place restrictions on the production, marketing and use of substances and preparations containing creosote and wood treated with such substances, depending on various limit values of the B[a]P content: 5 ppm, 50 ppm and 500 ppm. (8) The German legislation applies to both, creosote and preparations containing creosote, as well as products made of wood, partially or completely, that have been treated with creosote or products containing creosote. (9) Restrictions on marketing and use of creosote and wood treated with creosote are the following: 1. Sale to private consumers preparations prohibited, irrespective of their B[a]P content. containing of creosote creosote is and completely 2. Creosote with a B[a]P content lower than 5 ppm: (a) use is only allowed in closed industrial installations, 3. Creosote with a B[a]P content in the range of 5 to 50 ppm: (a) placing on the market is only allowed for use in installations by application of closed industrial certain impregnation techniques: - pressure impregnation with final vacuum - other impregnation processes for the partial impregnation of wooden posts, which ensure an in-depth protection, especially the dipping in the hot-cold process with final reduction of creosote content at the surface - other processes ensuring equal or better protection of man and environment; (b) sale of wood treated with such creosote is prohibited if impregnation has not been done abovementioned according techniques; to one of the (c) sale of treated wood is completely prohibited for use inside buildings, on children’s playgrounds or other purposes with regular human skin contact, or as a consumer product within the definitions of the Foodstuffs and consumer products Act. 4. Creosote with a B[a]P content in the range of 50 to 500 ppm: (a) use is permitted only for industrial treatment of railway sleepers and electricity poles in a process of pressure impregnation with final vacuum, (b) sale of wood treated with such creosote is prohibited except for use as railway sleepers or electricity poles intended for export to countries where increased conditions climatic wood protection. require (b) sale of wood treated with such creosote by brushing, spreading, or dipping is prohibited, 5. In addition, all types of creosote with B[a]P content up to 500 ppm may be placed on the market for 22. 12. 1999 EN Official Journal of the European Communities L 329/45 exclusive use in countries, where climatic conditions require increased wood protection. 6. Previously treated railway sleepers, electricity poles and posts may be marketed again as such (even when the indicated limits are exceeded). Such marketing is, however, prohibited if: - impregnation took place less than 15 years ago - fresh cut sites have not been permanently sealed or covered - wood is intended for use inside buildings, in children’s playgrounds or other purposes with regular human skin contact - wood products are intended for private consumers - the products are consumer products under the Foodstuffs and consumer products Act. (10) The German national legislation regarding tar-oils was amended for a second time by an ordinance of 12 June 1996. The latter transposed a part of the provisions of Directive 94/60/EC into German law. first contain version, the German regulations did not provisions concerning the content of water soluble requirements phenolic creosote of regarding compounds creosote, in the minimum drum size In their and a specific compounds containing 50 to 500 ppm B[a]P or specific labelling requirements of preparations containing such creosote, whereas the Directive establishes a maximum content of 3 % phenolic labelling requirement for creosote containing more than 50 ppm B[a]P. These provisions, being more restrictive than the initial German regulations, have been incorporated in the Banned Chemicals Ordinance and the Hazardous Substances Ordinance by the amending Ordinance in 1996. However the labelling requirement is slightly different from the Community provisions. The German national legislation requires the following wording: For exclusive use in the pressure impregnation with final vacuum for railway sleepers and electricity polesí. Furthermore the second amending decree restricted even further the use of old treated wood: in addition to the restrictions mentioned above, previously treated railway sleepers, electricity poles and posts may only be marketed áas suchí again. 3. Comparison between the German provisions and Directive 94/60/EC (11) Table 1 shows in detail the differences between the restrictions on the marketing and use of creosote and wood treated with creosote depending on the B[a]P content as laid down in Directive 94/60/EC and the German legal system in force at the date of adoption of the Directive. Table 1 Comparison between Directive 94/60/EC and the German regulations Council Directive 94/60/EC German regulations B[a]P < 5 ppm No restrictions on sale or use of creosote or newly treated wood Sale of creosote to private consumers and for use inside buildings prohibited Industrial use only in closed plants applied by brushing, treated wood prohibited if creosote Sale of spreading, or was dipping, or for use in inside areas or as a consumer product within the definitions of Foodstuffs and consumer products Act L 329/46 EN Official Journal of the European Communities 22. 12. 1999 Council Directive 94/60/EC German regulations B[a]P in range 5-50 ppm No restrictions on sale or use of creosote or newly treated wood of Sale prohibited creosote to private consumers Industrial use only in closed plants with certain impregnation techniques: - pressure impregnation with final vacuum - other processes with equal protection of man and environment - other impregnation processes for partial impregnation of wooden posts which ensure an in-depth protection, especially dipping in hot-cold process with final reduction of creosote content on the surface of prohibited treated wood Sale if impregnation has not been done with the abovementioned techniques. Sale of treated wood completely prohibited for use inside buildings, on children’s playgrounds or other purpose with regular skin contact, or as a consumer product within the definitions of Foodstuffs and consumer products Act. of private creosote Sale consumers to prohibited. However, all types of creosote with B[a]P content up to 500 ppm may be placed on the market for exclusive use in countries, where climatic conditions require increase wood protection Use permitted only for industrial treatment of railway sleepers and electricity poles in a process of pressure impregnation with final vacuum Sale of treated wood prohibited except for use as railway sleepers or electricity poles intended for climatic conditions require increased wood protection. countries where export to B[a]P 50-500 ppm Restrictions on sale of creosote: - no sale to private consumers - use only permitted in industrial installations. Minimum drum size 200 l. Special labelling required Treated wood may only be used for professional and industrial applications: - railways - electricity poles - fencing - waterways Explicit restrictions on treated wood. It may not be used: - inside buildings - in contact with foodstuffs - for containers for growing purposes - at playgrounds or other sites at risk of skin contact 22. 12. 1999 EN Official Journal of the European Communities L 329/47 Council Directive 94/60/EC German regulations B[a]P > 500 ppm or water soluble phenols >3 % Sale and use of products totally banned creosote and treated Sale and use of creosote and treated products totally banned when B[a]P content > 500 ppm (no provisions on water soluble phenols!) Old treated wood Use controlled as for wood treated with creosote containing B[a]P between 50 and 500 ppm Previously treated railway sleepers, electricity poles and posts may be marketed again (even when the limits indicated are exceeded). Such marketing is, however, prohibited if: - impregnation was less than 15 years before - fresh cut sites have not been sealed - wood is intended for use inside buildings, other in or purpose with regular skin contact playgrounds children’s - wood products are intended for private consumers - the products the under products Act are Foodstuffs consumer products consumer and (12) In summary the German provisions are more restrictive in several aspects: applications (railway sleepers, electricity poles for export), - creosote and preparations containing creosote may not be sold to the private consumer irrespective of their B[a]P content, - placing on the market and use of previously treated wood are further restricted in comparison to the EC Directive. - placing on the market of creosote and preparations containing creosote with a B[a]P content up to 500 ppm is only possible for export to countries with climatic conditions requiring enhanced wood preservation and, domestically, for industrial use. the use of Furthermore, creosote and preparations containing creosote with regards to process technology have been established depending on the B[a]P content (5, 5 to 50, and 50 to 500 ppm), specific obligations for - newly treated wood may not be placed on the market unless certain obligations with regards to the treatment process have been met. Additional restrictions apply for the use of wood treated with creosote containing less than 50 ppm. Wood treated with creosote containing B[a]P in the range 50 to two specific 500 ppm may only be used for II. THE PROCEDURE (13) Directive 94/60/EC was adopted on 20 December 1994. The Directive had to be transposed into the national law of the Member States no later than one year after its adoption, i. e. by 20 December 1995 (Article 2(1), first subparagraph) and the national provisions had to be applied from 20 June 1996 (Article 2(1), second subparagraph). (14) By letter of 4 July 1995, Germany transmitted a report (dated 19 June 1995) by which they informed the European Commission that on grounds of health protection Germany deemed it necessary to continue to apply the already existing legislation relating to átar-oilsí, and requested a derogation on the basis of the former Article 100a(4) of the EC Treaty from Directive 94/60/EC with regards to creosote. It was also stated that some amendments would be made in order to L 329/48 EN Official Journal of the European Communities 22. 12. 1999 incorporate a part of the provisions of the Community These the Directive amendments were notified on 8 July 1996. legislation. national into (15) By letter of 6 December 1995, the Commission invited the other Member States to present their observations the former Article on the German request under 100a(4). The Commission received comments from Denmark, Sweden, The Netherlands, Austria, and the United Kingdom. (20) (16) Denmark recalls that in its opinion, creosote is a dangerous substance to both human beings and the environment, and its use should be restricted as far as possible, or banned completely. Denmark therefore fully supports the idea that Germany should be given the rules with option to apply more stringent national regards to creosote. to have the greatest effects on German companies. the more stringent Austria therefore considers measures constitute neither an arbitrary discrimination nor a disguised restriction on trade. that the standards In contrast, the United Kingdom objects to the request from Germany. The UK authorities consider that the German request is based on a disagreement with scientific consensus, which was reached at Community level during the adoption of Directive 94/60/EC. Following the UK opinion, all Member States should accept single market measures, unless there are special circumstances which would lead to an increase of risk in one Member State if similar provisions applied. The UK is not aware of any special circumstances in Germany, which would justify the application of more stringent measures. The UK also points out that the threshold of 50 ppm B[a]P used in the Directive is entirely consistent with the classification criteria used in Directive 67/548/EEC. imposed by (17) Sweden shares the German views regarding the risks posed by creosote and wood treated with creosote and has no objections to the notified more stringent German provisions. Sweden underlines that creosote has adverse impacts as it is highly toxic to certain environmental are aquatic bioaccumulating. and creosote-treated wood should therefore be limited in order to minimise the risk of damage. Sweden recalls that it had also notified its intention to maintain its national provisions on creosote in view of special circumstances applying in its territory. components creosote certain use organisms The and of (18) The Netherlands recall that, they had made a statement in the Council underlining that the level of protection for public health, the workplace, and the environment set insufficient. The Netherland by the Directive was themselves already had notified a request for derogation under the former Article 100a(4). The Netherlands consider that the German measures meet a real need, and cannot be seen as a hidden barrier to trade, and the therefore Commission. confirmation support their by (19) According to Austria, is the the primary objective of the protection of consumer German provisions health, which is the objective of the former Article 100a(3). Austria agrees to the position that the cancer risk to consumers from direct dermal exposure to B[a]P containing tar-oils or wood treated with such tar-oils is considerable as the risks are highest during direct brush application of tar-oils (dermal and inhalatory exposure) and the (unnecessary) use of treated wood inside buildings. Austria therefore considers the continuous application of the national provisions as justified. The German regulations are proportional as they reduce the risk of exposure by addressing specific situations, while the free circulation of goods is only hindered to a very limited extent. Futhermore, the national measures seem (21) On the 1 May 1999, the Treaty of Amsterdam amending the Treaty on European Union, the Treaties establishing the European Communities and certain related acts, signed at Amsterdam, 2 October 1997, entered into force. By letter of 24 August 1999 the General the Commission informed Germany of the fact that their notification regarding the placing on the market and use of creosote would be treated in the framework of the new provisions of the Treaty. Secretariat of III. ASSESSMENT 1. Applicable Rules the former Article 100a of (22) The Treaty of Amsterdam has amended substantially the the Treaty provisions of establishing the European Community, by replacing paragraphs 3, 4, and 5 of this Article with eight new paragraphs numbered 3 to 10. Due to the new numbering of all Articles, the amended Article has the Treaty establishing the become Article 95 of European Community. (23) The Treaty of Amsterdam does not comprise specific transitional provisions on the rules applicable to the notifications made previously to the time of entry into force of this treaty like the German notification, which is the subject of this Decision. (24) In the absence of specific provisions extending their application, the old provisions of Article 100a(4) of the EC Treaty are regarded as repealed from the day of the 22. 12. 1999 EN Official Journal of the European Communities L 329/49 entry into force of the new provisions (1 May 1999). the Treaty apply Instead, immediately from that date to the examination of this notification. the new provisions of 2. Consideration of admissibility (25) The notification submitted by Germany intends to obtain the authorisation to maintain national provisions incompatible with Directive 94/60/EC, which constitutes a harmonisation measure adopted on the basis of the former Article 100a (now Article 95) of the EC Treaty. for maintaining them after notified, for which a Member State wishes to obtain the date of approval implementation of a Community harmonisation measure, that must have been adopted before the adoption of harmonisation measure. therefore exclusively deals with the legislation existing before adoption of Directive 94/60/EC as notified in the request of 4 July 1995. The provisions introduced by the amending Decree of 12 June 1996 (notified on 8 August 1996), for which an approval has not been requested, implement certain provisions of Directive 94/60/EC and are not subject to this Decision. This Decision 3. Assessment of merits (26) Article 95(4) of the Treaty reads as follows: If, after the adoption by the Council or by the Commission of a harmonisation measure, a Member State deems it necessary to maintain national provisions on grounds of major needs referred to in Article 30, or relating to the protection of the working environment environment, it shall notify the Commission of these provisions as well as the grounds for maintaining themí. the or (27) Directive 94/60/EC had to be transposed by the Member States by 20 December 1995 and enforced by 20 June 1996. Germany notified its national legislation relating to átar-oilsí which it intended to maintain on 4 July 1995 and thus before the date foreseen for application of the national provisions transposing the Directive. (28) The national provisions for which derogation was sought had entered into force on 1 October 1991 and thus before Directive 94/60/EC was adopted (20 December 1994). (29) (30) law that were more In the notification Germany announced its intention to legislation in order to transpose amend the national those parts of the provisions of Directive 94/60/EC into national restrictive. By the amending ordinance of 12 June 1996, which was notified to the Commission on 8 August 1996, a maximum permissible content of water soluble phenols, a list of specific substances being covered by the term átar-oilí, and a minimum drum size and specific labelling requirement for tar-oils containing 50 to 500 ppm B[a]P were included. The existing restrictions for old treated wood were also slightly modified. In the light of what precedes, the Commission considers that the request of the Federal Republic of Germany for derogation from Directive 94/60/EC as notified on 4 July 1995 under is admissible under Article 95(4) of the EC Treaty. the national provisions According to Article 95(4), former Article 100a(4) the (31) to assure that all the Commission has In accordance with the provisions of Article 95 of the Treaty, the conditions enabling a Member State to avail itself of the possibilities of derogation provided for in this Article are met. The Commission has, in particular, to verify whether the provisions notified by the Member State are justified by the major needs of protection referred to in Article 30, or relating to the environment or working environment. In addition, the Commission has to verify, these measures are justified, when it considers that they are whether or not arbitrary a means of discrimination or a disguised restriction on trade between the Member States, and whether or not they constitute an obstacle to the operation of the internal market (Article 95(6)). (32) Germany has based its request on the need for protection of human health. In order to substantiate its request for derogation, Germany submitted a brief justification for the more restrictive national measures which was substantiated by three documents: A report from the Senate Commission on the testing of materials injurious to health of the German Research Association (MAK Commission) on the suitability of B[a]P as a marker substance for mixtures of polycyclic aromatic hydrocarbons originating in combustion processes (completed in 1984), a study on the carcinogenic properties of B[a]P (4), and a collection of data on the identity, availability, and application of alternative wood protection agents toxicological and including their ecotoxicological effects. However, it was not possible to examine the merits of the request based exclusively on this information. (33) to verify whether In order provisions creosote-treated wood, concerning marketing the German national of and use indeed necessary and are (4) J. M. Holland, E. L. Frome, Advances in modern environmental toxicology, Vol. VI, Applied Toxicology of petroleum hydrocarbons, ed. MacFarland et al. , Princeton Scientific Publishers 1984. L 329/50 EN Official Journal of the European Communities 22. 12. 1999 contamination proportionate to that end, the Commission mandated a study to an external consultant to assess the situation of environmental in Germany (5). In addition, the findings of three further studies (6), which were mandated by the Commission in the framework of similar requests from other countries, have been used in the assessment of the request from Germany. creosote by (34) It has to be noted that, in the light of the time frame established by Article 95(6), which did not exist in the former Article 100a(4) under the regime of which the German request was notified, these substantial efforts of the Commission to find the elements necessary for the justification of the maintenance of the German national provisions cannot constitute a precedent for the future. When examining whether the national measures notified under Article 95(4) are justified by a major need, the Commission has to take as a basis áthe reasonsí put forward by the Member State to justify the maintenance of its national provisions. This means that, according to the provisions of the responsibility of proving that these measures are justified, lays with the requesting Member procedural framework established by Article 95, the Commission normally has to limit itself to examining the relevance of the elements which are submitted by the requesting Member State, without having to seek itself possible reasons of justification. State. Given the Treaty, the a as designed specifically (35) None of the studies referred to above was completely conclusive with regards to the effects of creosote on human health, in particular concerning its carcinogenic long-term potential, carcinogenicity study was still ongoing. This study (7) was made available to the Commission at the beginning of 1998. The findings of all these studies are set out below. In addition, all studies have been made available to the Scientific Committee on Toxicity, Ecotoxicity, and the Environment, which expressed a first opinion on the cancer risk to consumers from creosote and/or wood treated with such creosote on 27 November 1998. This opinion was revised on 4 March 1999. (5) Environmental resources management, Scientific evaluation of the German request for derogation from provisions of Council Directive 94/60/EC concerning creosote, Final report, 24 April 1996. für (6) G. Grimmer, Study on the justification in scientific terms of allowing The Netherlands to retain its national laws on creosote in place of Council Directive 94/60/EC. Final report, Biochemisches Institut (Germany), Umweltcarcinogene, Großhansdorf December 1995. Dr. P. M. Sorgo, Study on the justification in scientific terms of allowing Denmark to retain its national laws on creosote, Final report, November 1996. W. S. Atkins international Ltd, Study on the justification in scientific terms of allowing Sweden to retain its national laws on creosote in place of Council Directive 94/60/EC, Final report, August 1997. (7) Fraunhofer Institute of Toxicology and Aerosol Research, Dermal carcinogenicity study of two coal tar products (CTP) by chronic epicutaneous application in male CD-1 mice (78 weeks), Final report, Hannover, October 1997. 3. 1. Justification on grounds of major needs 3. 1. 1. Creosote general information (36) Creosote is a complex mixture of over 200 chemical compounds, predominantly aromatic hydrocarbons, as well as phenolic and aromatic nitrogen and sulphur compounds. tar (boiling point approximately 200 to 400 °C). is a mid-heavy distillate of coal It (37) Creosote can contain over 30 different polycyclic aromatic hydrocarbons (PAHs) with a possible total PAH content of 85 %. The most important ones are: - acenaphthene - naphthalene - phenanthrene - anthracene - fluorene - fluoranthene - chrysene - tripenylene - benzo[a]anthracene - benzo[b]fluoranthene - benzo[k]fluoranthene - benzo[a]pyrene (38) Benzo[a]pyrene (B[a]P) is one of the most thoroughly investigated PAHs and the B[a]P content is used as an indicator or marker substance for classification purposes and does not, in itself, reflect the total PAH content of creosote. Depending on the type of creosote concerned, the B[a]P content may vary between 0,003 % and 0,3 % by weight (30 to 3 000 ppm). A refined distillation of coal tar and selection of the fractions can lead to lower B[a]P or phenols contents. Different industry standards have been developed by the Western European Institute for Wood Preservation, characterised mainly by different contents of specified distillation fractions and, most important in this context, different contents of B[a]P. Limiting values for classification standards are 500 ppm and 50 ppm. (39) Modification to both the physical and chemical properties of creosote are possible if they are required for use or environmental purposes. is possible to create a lower viscosity product, better suited to brush It 22. 12. 1999 EN Official Journal of the European Communities L 329/51 application, by incorporating components with a lower boiling point, which is sometimes called carbolineum. Directive 94/60/EC does not make a distinction: it covers and treats in an identical way a whole range of different coal tar distillates, all of them specified by their names, Einecs and CAS numbers. (40) Creosote is principally and almost exclusively used as a wood preserving agent. Large-scale and professional applications are by far the most important ones: railway sleepers, poles for electricity transport, hydraulic engineering (bank protection), agriculture and fruit production. Creosote and similar products are also used by individual consumers for wood preserving purposes. industrial (41) The most important properties of creosote are: - high fungicidal efficacy - high insecticidal efficacy - long-term persistence - resistance to leaching and weathering. (42) A very small quantity of creosote is used in medicinal products for the treatment of certain skin diseases, for example psoriasis. T o x i c i t y o f c r e o s o t e : Human health effects (43) Despite the fact that creosote has been used as a wood preservative for over a century, there is very little published data on the effects on humans of sustained exposure to creosote. Many of the studies are rather old and do not always conform to modern standards with regards to documentation. (44) Exposure can occur via inhalation, ingestion, or skin contact. Creosote is evaluated as mildly to moderately toxic by ingestion. Most effects resulting from animal experiments and all epidemiological studies in humans are linked to dermal exposure. (45) Skin photosensitivity from coal tars has been described by a number of authors. Irritation symptoms, pitch warts, skin discoloration and dermal tearing have been reported to occur among workers exposed to creosote. The most recent study on workers exposed to creosote in Sweden and Norway was published in 1992 (8). The (8) S. Karlehagen et al. , Cancer incidence among creosote-exposed study examined workers exposed to creosote between 1950 and 1975. The investigators found a somewhat incidence than expected and an lower total cancer increased risk of cancer of the skin and lip and of non-Hodgkin lymphomas. However, the composition of the creosote was not documented and the authors conclude that the small number of cases did not permit valid conclusions. The increase could be attributed to exposure both to creosote and to sunlight. One other study (9) found an increased risk of mortality from for brickmakers exposed to creosote scrotal cancer during the period 1911 to 1938. Again, neither the B[a]P content of the creosote nor a clear dose response relationship is known. life-time (10), (46) Mostly based on an animal experiment, where the skin of mice war regularly exposed to B[a]P solutions in the International acetone during their Agency for Research on Cancer (IARC) has classified creosote as a group 2A human carcinogen. The IARC estimates there is sufficient evidence that creosote is carcinogenic in animals and certain evidence from epidemiological studies to conclude that creosote can be carcinogenic in humans. There is no significant new evidence from more recent this conclusion. investigations, which would affect in this class substances that for (47) For several years, experts from the Member States examined the issue of classification of creosote, other coal tar distillates, and further ácomplex substancesí in the framework of Council Directive 67/548/EEC of 27 June 1967, relating to the classification, packaging and labelling of dangerous substances (11), as last amended by Directive 99/33/EC (12). Drawing largely on the same data as the IARC, agreement was reached during the elaboration of Commission Directive 94/69/EC (13), the 21st adaptation to technical progress, according to which creosote and some other coal tar distillates are classified as category 2 carcinogens and must be labelled with the risk phrase R 45 May cause cancerí. However, the classification as a carcinogen need not apply if it the substance contains less than can be shown that 0,005 % (= 50 ppm) per weight B[a]P (14). This is different from the IARC classification, which applies without any specification of the B[a]P content. (48) The choice of a limit of 50 ppm in the concentration of in Community classification purposes B[a]P for (9) IARC, Monograph on the evaluation of carcinogenic risk to humans, Vol. 35, polynuclear aromatic compounds, Part 4, bitumen coal tars and derived products, shale soils and soots, Lyon, 1985. (10) See footnote 4. (11) OJ L 196, 16. 8. 1967, p. 1. (12) OJ L 199, 30. 7. 1999, p. 57. (13) OJ L 381, 31. 12. 1994, p. 1. (14) Note M of the foreword to Annex I to Council Directive workers, Scand. J. Work environment health, 1992:18, p. 26. 67/548/EEC is applicable to creosote. L 329/52 EN Official Journal of the European Communities 22. 12. 1999 legislation in order to distinguish carcinogenic from non-carcinogenic coal-tar distillates has been accepted by the Member States in the working group for the adaptation of Directive 67/548/EEC to technical progress only on the basis of a joint declaration by the Commission and the Member States. The declaration states that the situation would be reviewed when the results of the abovementioned scientific study by the Fraunhofer Institute were known, which had been initiated by industry in collaboration with the IARC and was in progress at that time. It has to be recognised that in 1994, there were no experimental data available to prove whether creosote containing less than 50 ppm B[a]P was carcinogenic or not. This situation has changed and the results of the Fraunhofer study will be presented below. through the skin by measuring (49) Little is known about the toxicokinetics of creosote in humans or experimental animals. Only very recent studies have investigated quantitative absorption of PAHs excreted metabolites of pyrene (15): absorption appears to vary between individuals and between different sites within the same individual. In a separate study (16), the dermal absorption of different PAH compounds was measured. PAHs of higher molecular weight for rapidly. Any example B[a]P were estimation of B[a]P uptake based on the pyrene marker will therefore result in an overestimation and can be considered conservative. than pyrene, absorbed less (50) It has to be noted that all effects observed in animal experiments or in in epidemiological humans are based on high level chronic exposures. No reports have been found in the literature of examples of cancer of the skin (or any other sites) which could be attributed to exposure to creosote in a non-occupational environmental context. investigations (51) Exposure of consumers can occur during the use of preparations containing creosote (or carbolineum) for wood preservation by brush application (dermal and inhalatory) or through the use of treated wood (e. g. adults during the construction of fences or other wooden structures for private use, children playing on structures made of treated wood). No measured data are available concerning the exposure of consumers to creosote, either directly through use of the product, or indirectly through contact with wood treated with creosote. Various models and calculations of exposure have been developed in the studies and will be discussed later. (15) Van Rooij, J. G. M. , et al. , Absorption of polycyclic aromatic hydrocarbons through human skin: differences between anatomical sites and individualsí, J. Tox. environ. health, 38, 1993, p. 355. (16) Van Rooij, J. G. M. , Dermal exposure to polycyclic aromatic ISBN 90-9007080-X, among workersí, Thesis hydrocarbons Nijmwegen 1993. Environmental effects facilities often being the source of (52) Environmental contamination by creosote has been reported in a number of countries, with old wood the treatment contamination. In fact, most information on the fate of creosote in the environment has been obtained from industrial creosote spills and from contamination left Environmental from disused contamination has been traced by an analysis of selected PAH compounds, notably B[a]P. creosote plants. (53) Creosote is toxic to certain organisms in the soil and highly toxic against aquatic organisms (with 96h LC-50 values often below 1 mg/l). Many of its components are bioaccumulating. (54) The main characteristics of PAHs in the environment are: - PAHs bind strongly to soil organic matter - the rate of degradation of PAHs in soil and other environmental slow. compartments Creosote residues can persist for many years in the environment (> 20 to 30 years) usually is - the main breakdown processes are photodegradation (i. e. under irradiation from the sun) and microbial degradation (i. e. by certain bacteria). Microbial degradation can occur under aerobic and Anaerobic conditions. PAHs compounds with four rings and more may be poorly degradable - PAHs reaching watercourses are rapidly transferred to sediment are removed primarily - in watercourses, most of the lower molecular weight PAHs by microbial degradation and the higher molecular weight compounds by photooxidation and sedimentation. the more water soluble Microbial degradation of PAHs and Anaerobic conditions. The PAH constituents have been shown to bioaccumulate in aquatic species. aerobic occurs under (55) Emissions of PAHs to air, water and soil can occur during the impregnation process and storage at the impregnation site, as well as during use of treated wood. However, PAHs found in the various environmental compartments originate from a variety of sources (e. g. all combustion processes, traffic, etc. ) and it is often difficult to ascribe their levels to any particular source such as creosote-treated wood. 22. 12. 1999 EN Official Journal of the European Communities L 329/53 (56) A study (17) in Sweden has shown that after 40 years in soil, creosote impregnated poles had lost a part of the compounds contained in creosote, notably those with the lowest boiling point (< 270° C). The part of the poles above the ground lost the larger amount. However, mobility of the leached compounds was very low as they could only be detected in the soil in close contact with the poles. This is coherent with the observation that the mobility of PAHs in soil is extremely low due to their strong absorption in organic matter. of creosote-treated wood. Migration (57) The presence of elevated levels of PAH in aquatic environments has often been attributed to the presence creosote of components from treated wood into water is higher into fresh water than into seawater and has been proven in many studies. Migration seems to be more limited in seawater; in one study, after 10 years in the sea, marine pilings retained 93 % of the original composition of creosote compounds (18). The pollution of sediments by creosote leaching from waterbank protection has been documented in The Netherlands (19) and also in studies on pollution from former impregnation facilities. (60) Germany holds the opinion that the stricter national measures are necessary due to the high carcinogenic potential of tar-oils. A reduction to the level of protection as established by Directive 94/60/EC would lead to an unacceptable additional risk to the population of contracting cancer. (61) Depending on their origin and on the production tar-oils varies. the carcinogenic potency of process, level of Individual every tar-oil component is impracticable. Nevertheless, in order to be able to take a position on the effect level, the MAK-Kommission has carried out an extensive evaluation of the available data and has concluded that: the carcinogenic effect testing of - B[a]P can be used as a reference substance for estimating the carcinogenic effect of tar-oils - the carcinogenic effect of tar-oils is greater by a factor of 7 to 20 than the effect due to the B[a]P-content alone. (58) As for human exposure, actually measured data on in pollution by originating PAHs environmental creosote are scarce. 3. 1. 2. The position of Germany is by in general (59) Germany justifies its request for maintaining the more in place of Directive restrictive national provisions the level of 94/60/EC exclusively on the claim that the Community health protection guaranteed provisions insufficient, especially with regards to health hazards to consumers. Germany does not share the assessment that hazards related to the use of creosote containing less than 50 ppm B[a]P and wood treated with such creosote are very low, as it has been agreed during elaboration of Directive 94/69/EC, the 21st adaptation to technical progress of Directive 67/548/EEC, according to which coal-tar distillates containing B[a]P in concentrations lower than the limit value of 50 ppm B[a]P need not be classified as carcinogens. Germany bases judgment on a study (20) published in 1984 presenting the results of carcinogenicity tests with B[a]P. the its (17) S. Holmroos, Analys av kreosotstolpar i Simlångsdalen efter 40 års exponering i fält. Rapoort nr. M205-252. 092. ˜lvkarleby: Vattenfall Utveckling. 1994. (18) L. L. Ingram et. al. , Migration of creosote and its components from treated piling sections in a marine environmentí, Proc. ann. meet. AM. wood preserv. assoc. 78, 1982, p. 120. See also footnotes 8 and 13. (19) See footnote 8. (20) See footnote 4. however, (62) Therefore, Germany agrees that, for pragmatic reasons, the effect level of tar-oils can be assessed on the basis of their content of certain constituents, for example B[a]P. cannot quantified This, assessments, different the carcinogenic substances tar-oils are not the substances have been identical and not all of identified and classified. For many of them, precise effect levels are not known. lead contents of in various since fully the to consumer. the private (63) According to Germany, the primary aim of the national regulations restricting tar-oils is the protection of the the In addition, health of provisions have effects of protecting workers and the environment. As the determining factor for the broader restrictions was the hazard to the health of the private consumer, Germany does not proceed the with any further analysis of professional user or the environment. the exposure of the positive (64) In estimating the hazards to the private consumer, the following types of potential exposure have been identified by Germany: - skin contact during the use of through brush application), tar-oils (generally - skin contact in the course of installing/carrying out carpentry work on the treated wood, - skin contact with the installed treated wood, - inhalation exposure in the course of using the tar-oils, - inhalation exposure to tar-oil components which escape from the treated wood as gases. L 329/54 EN Official Journal of the European Communities 22. 12. 1999 (65) is recognised that the level of actual exposure to It shows a marked dependency on individual tar-oils behaviour, as is usual in the consumer sector. When considering the exposure provisions, therefore, account must be taken of those situations where the level of exposure is considerably above the average (worst-case scenarios). and use of wood treated with creosote containing B[a]P in the range 50 to 500 ppm are necessary, as despite the reduction in tar-oil content at the surface of wood treated that way, there is still a considerable hazard to relatively frequent and even health in the case of either measured, or occasional estimated are presented to support these assertions. contact. No data, (66) Germany considers that according to the data of the only study establishing a dose-response relation for exposure to B[a]P (21), a solution containing 50 ppm of B[a]P causes skin tumours in 95 % of the animals. A less concentrated solution, containing 25 ppm of B[a]P, still produces tumours in 44 % of the animals, which proves that also at this concentration B[a]P is a strong dermal carcinogen in mice. (70) In what concerns the restrictions on the sale of used wood which was treated previously, they are considered necessary since there is an unacceptable cancer risk from skin contact as in the past tar-oils had higher the wood B[a]P contents, can be surface, considerable even after a number of years, and tar-oils migrate from freshly cut sites of the wood. No data, either measured, or estimated, are presented to support this assertion. the content of solar especially under tar-oil at exposure, (67) Germany justifies their claim that the level of protection established by Directive 94/60/EC is insufficient, by analysing more thoroughly one of the five exposure scenarios mentioned above: through the calculation of a risk assessment for children playing on wood treated with creosote containing 25 ppm B[a]P. Frequency of contact is assumed to be once a week over five years, tar-oil each time. Assuming a transferring 10 µl of lifetime of 70 years, the cumulative lifetime risk calculated by Germany is 0,02 (2 %). (71) Finally, according to Germany, less hazardous and equally effective substitutes for creosote are available for legislation bans or all applications where the national restricts more severely the use of tar-oils than the EU Directive. the German request contains a report on various wood preservation agents, giving the names as well as the health and environmental hazards presented by the substitutes. However, tar-oils are not covered by the report. In support of this opinion, (68) Germany thus arrives at the conclusion that the In cumulative lifetime risk is in the percent range. internationally acceptable cancer for contrast, risks substances are situated in the range of individual 1 × 10-5 (i. e. 0,001 %). The potential cancer risk of tar-oils containing 25 ppm of B[a]P and of wood treated with such oils, therefore, is not acceptable. Furthermore, the exposure dose is estimated for children playing on treated wood, only taking into account dermal exposure and probably underestimating the actual risk (which could be higher owing to inhalation and oral ingestion). according Germany, thus, to required (69) Germany justifies the other part of their more restrictive national measures, impregnation the technologies and the restrictions on the marketing and use of treated wood, also by referring to this evaluation according to which the health risks to consumers would otherwise prescribed unacceptable. Only be impregnation processes a high depth of penetration of the tar-oils and therefore permanent and effective protection of the wood. The reduction of the tar-oil content at the wood surface, which is required following the treatment, to minimise the health hazards. Simple brush application by consumers leads to ineffective impregnation as well as high exposure during application and from elevated surface concentrations. Restrictions on the marketing is necessary in order ensure the (21) See footnote 4. 3. 1. 3. Evaluation of the German position E x p o s u r e o f t h e e n v i r o n m e n t (72) The study made by ERM undertook to examine all available information regarding the possible direct exposure of the German population to unusually high doses of creosote through products sold to consumers and by contact with creosote-treated wood, as well as regarding the possible direct exposure of the German aquatic environment to high doses of PAH from creosote-treated wood in order to establish whether there was a specific situation, albeit not invoked by that could justify maintaining the more Germany, restrictive national measures in place of Directive 94/60/EC. (73) As mentioned in the for wood treatment chapter containing general the application of coal-tar information on creosote, distillates is only one possible source of emissions of B[a]P and other PAHs into the environment. Emissions occur in association with a broad range of human activities, the main sources today being traffic, industrial activities, and energy generation. Table 2, originating from the ERM study gives an overview on estimated emissions of B[a]P in several European countries. 22. 12. 1999 EN Official Journal of the European Communities L 329/55 Table 2 Estimated emissions of B[a]P in selected European countries (22) Country Total emissions (t/year) Source (%) Fuel combustion Transport Industry Others Denmark Sweden Norway Germany United Kingdom France Netherlands Europe 1 6 8 215 49 54 7 1 409 57,5 42,0 14,9 79,9 61,2 26,2 20,0 69,3 0,0 2,0 72,6 1,3 0,7 34,5 4,8 6,0 21,2 48,2 9,6 17,1 32,8 34,3 67,5 23,3 21,3 7,8 2,9 1,7 5,3 5,0 7,7 1,8 (74) It is clear from Table 2 that the use of creosote (which would be comprised in category áothersí or áindustryí) constitutes only a small contribution to overall B[a]P levels in the German environment. (75) A recent study (23) using the German Environmental Specimen Bank (supported by the German Ministry of Environment) which provides a historical databank of a range of different species from selected locations within Germany, has concluded that PAH concentrations have decreased significantly in the atmospheric and marine environment in the period 1985 to 1994. (76) Table 3 gives an overview of the consumption of creosoted wood in Europe. Table 3 Consumption of creosoted wood in Europe (1990) (24) Country Annual use in 1990 (m3/y) Annual use/capita (10ﬂ3m3 /cap. y) Annual use/km2 (m3/km2. y) Germany Netherlands Spain Italy United Kingdom Sweden France Belgium Norway Ireland Finland Denmark Europe 150 000 100 000 93 000 74 000 65 000 57 000 45 000 26 000 20 000 20 000 13 000 5 000 1 000 000 2,3 6,7 2,4 1,3 1,1 7,1 0,8 2,6 5,0 5,0 2,6 1,0 2,0 0,4 2,9 0,2 0,3 0,3 0,1 0,08 0,8 0,06 0,3 0,04 0,1 0,2 (22) Source: van den Hout KD, 1994. The impact of atmospheric deposition of non-acidifying pollutants on the quality of European forest soils and the North Seaí, main report of the Esquad project, p. 145. (23) J. Jakob, G. Grimmer, A. Hildebrandt, Trends in environmental pollution by PAH in Germany during the period 1985 to 1995í, published in Polycyclic aromatic compounds (1996). (24) bkh consulting engineers, Foundation of the appeal against the EC of Directive on creosote, Final report, Delft, 1 July 1995, p. 6. L 329/56 EN Official Journal of the European Communities 22. 12. 1999 (77) In Europe a total of 1 million m3 of creosoted wood was used in 1990. In absolute figures, Germany is the largest user of creosoted wood. However, the use per capita is not exceptionally high (rank 8 out of 12), the consumption per km2 is above average, but far lower than in The Netherlands. It is important to note that the data are from 1990, i. e. before the German regulations on tar-oils entered into force. (78) It is clear that there are no data supporting the existence of a specific situation in Germany with regards to pollution of the environment by PAH and B[a]P owing to the use of creosote and creosote-treated wood or the overall use of creosote-treated wood, which would necessitate a more restrictive national policy. H u m a n e x p o s u r e (79) Before commenting on the actual evaluations regarding the risks to human health, it has to be noted that none of the problems raised in this chapter are specific to Germany, and that all of them would apply in a similar manner to other Member States. (80) With regards to the risks to human health, it has to be noted that Germany neither presents new data (i. e. data unknown during the deliberations preparing Directive 94/60/EC) nor data demonstrating a higher exposure to creosote of the general population in Germany in comparison with the other Member States. The claim that the fact that the cancer risk of creosote containing less than 50 ppm B[a]P has been underestimated is sustained by referring to the same study that was used by the IARC for classification and was also discussed as a basis for assessing the carcinogenic potency of B[a]P and the the tar-oils Workshop carcinogenicity of complex and petroleum derived substancesí organised by the EC in Ispra in 1992, which let to the classification rules of Directive 67/548/EEC. This means that the study received due consideration before the adoption of Directive 94/60/EC. during on (81) The estimations made by Germany during the risk for children playing on creosote-treated assessment wood rely on a series of assumptions, which need to be compared with similar evaluations made by other assessors, notably those of the Dutch authorities and the study mandated by the Commission in the framework of the Swedish request for derogation under the former Article 100a(4) concerning the same Directive, as well as the Scientific Committee of Toxicity, Ecotoxicity, and the Environment. (82) The German assessment is fundamentally different from the others in so far as the dose of exposure to B[a]P is simply assumed to be identical to the total quantity of B[a]P transferred on the skin and is not calculated based on measured absorption data. The daily exposure dose to B[a]P according to Germany is 39,3 ng/day (assuming a transfer once a week of 10 µl creosote of a density of 1,1 g/ml containing 25 ppm B[a]P). (83) In contrast to the other studies, Germany does not take into account the body weight and skin specificities of the exposed individual humans by directly using a dose-response relationship from a study performed on mice. When normalising the calculated exposure to a body weight (bw) of 15 kg (as the other assessors have done), the daily dose amounts to 2,62 ng/kg bw/day. This is somewhat higher but not very different from the results of the Dutch authorities (2 ng/kg bw/day) and the study mandated by the Commission in the framework of the Swedish request (0,85 or 1,7 ng/kg bw/day). is (84) Despite the fact that the daily dose of exposure to B[a]P calculated by Germany (when normalised to the body from the dose weight) thus not very different (and the study estimated by the Dutch authorities mandated by the Commission for the Swedish request), the results for the calculated risk are, in fact, very different. According to the Dutch authorities, the risk is only slightly above an acceptable level (in the range of 1 × 10ﬂ5) for wood treated with creosote containing 50 ppm B[a]P and daily exposure over 10 years. In contrast, Germany calculates a risk which is orders of for wood treated with magnitude higher creosote containing only 25 ppm B[a]P with exposure once a week over five years, i. e. a much lower exposure results in a much higher risk. The assumptions made by Germany could thus lead to a clear overestimation of the risks involved. (2 × 10ﬂ2) (85) This interpretation is supported by the ERM study (25), which criticises the risk assessment made for children playing on creosote-treated wood presented in the German request and not quantitative. ERM points out that if the assumptions and calculations made by Germany were applied to exposure data measured for workers in occupational studies, all workers should have contracted skin cancer (risk higher than 300 %) which obviously was not the case. comprehensive as not (25) See footnote 5. 22. 12. 1999 EN Official Journal of the European Communities L 329/57 (86) Nevertheless, based on the assessments carried out by the Dutch authorities, and those contained in the two studies mandated by the Commission in the framework of the German and Swedish requests for derogation under the former Article 100a(4), the result that the likely exposure to B[a]P for children playing on creosote treated wood, which are mentioned above, is such that the risk is unacceptable, the claim of Germany that Furthermore, cannot both consultants recommend that the Commission, before taking a decision, awaits the results of the long-term carcinogenicity study that was ongoing at that time (26) (received at the beginning of 1998). The findings of this study have been examined by the Scientific Committee for Toxicity, Ecotoxicity, and the Environment and the analysis will be presented below. dismissed. totally be 3. 1. 4. Evaluation of the Scientific Committee for Toxicity, Ecotoxicity, and the Environment to progress technical (87) During the elaboration of Directive 94/69/EC, the 21st adaptation of Directive 67/548/EEC, a B[a]P content of 50 ppm had been accepted as safe by the Member States. However, as was already mentioned, the Commission and the Member States agreed in a Joint Declaration to review the the study situation in the light of concerning the coal-tar distillates currently undertaken on initiative of industry and in collaboration with the IARC. carcinogenic properties of the results of (88) This study (27) was made available to the Commission in January 1998. The study tested the carcinogenic effects of two creosote products provided by the sponsoring company (Rüttgers-VfT AG, Germany) containing 10 and 275 ppm B[a]P. Owing to the high viscosity of the products, they could not be applied directly to the skin of the mice but had to be diluted in toluene. Solutions with various concentrations of the products and thus various B[a]P concentrations, as well as pure B[a]P solutions and a control of pure toluene were applied to groups of 62 mice over a period of 78 weeks (twice a week, 25 µl). Development of tumours was observed during this time and the test animals were carefully examined after termination of the study. (89) The Commission submitted this study and all other documents exposure information on creosote to the Scientific Committee for Toxicity, Ecotoxicity and the Environment. The SCTEE containing scientific and (26) See footnote 7. (27) See footnote 7. was asked to evaluate whether there was sufficient scientific evidence to support the opinion that there is a cancer risk to consumers from creosote containing less than 50 ppm B[a]P and/or from wood treated with such creosote, and if such a risk exists, whether its magnitude can be estimated or quantified. The SCTEE adopted its opinion on 27 November 1998. (90) The SCTEE observes that there the Fraunhofer including B[a]P, study is well-designed and reaffirms the carcinogenic potential of coal-tar preparations. Owing to the genotoxic potential of PAHs is no threshold concentration determining carcinogenicity. The study indicates clearly a linear dose-response relationship between the B[a]P administered preparations and the number of animals developing tumours. Both preparations have a fivefold higher than pure B[a]P, potency to induce skin tumours presumably the other carcinogenic substances in creosote. It can be inferred from the study that creosote containing 50 ppm B[a]P would induce a significant incidence of skin cancer in mice. to the presence off content of due the are exposure (91) Data to fully evaluate the relevance of effects seen during a study on the application on mouse skin for human insufficient. situations Extrapolating skin carcinogenicity data from mice to the human situation also entails a number of uncertainties leading to difficulties in directly using cancer potency data from mice to assess the cancer risk in humans. Species dependent sensitivity of dermal exposure to the carcinogenic actions of creosote will be affected by the morphology and physiology of the skin, by metabolic activation and inactivation in the skin and by repair processes. On the basis of all the available information, a scientifically justified assessment of carcinogenic risk, for example for the dermal exposure of children playing on wood treated with creosote is therefore difficult. (92) From the data contained in the Fraunhofer study, the SCTEE calculated a T 25 carcinogenic potency value for pure B[a]P of 13 µg/kg bw/day. The T 25 is the chronic daily dose per kg bodyweight, which induces in 25 % of the test animals tumours at a specific tissue site within the standard lifespan of species. The creosote formulations five-fold higher overall carcinogenic potency (2,7 µg/kg bw/day). tested had a that children playing on creosote (93) Should the value of exposure estimates for the scenario treated wood as of calculated by Germany (2,62 ng B[a]P per kg bw/day) approximate the true exposure, this would result in a life-time cancer risk of 2,52 × 10ﬂ4 for a life long daily exposure which gives clear concern, a risk of 3,6 × 10ﬂ5 for a daily exposure over ten years out of 70 (the Dutch L 329/58 EN Official Journal of the European Communities 22. 12. 1999 assumption) and 1,8 × 10ﬂ5 for a daily exposure over five years out of 70 (the German assumption). Using the doses as calculated by the Dutch authorities (2 ng/kg bw/day) or in the study mandated by the Commission for the Swedish case (0,85 or 1,7 ng/kg bw/day), would reduce these risks proportionally. (94) Based on the most recent study with regards to the dose-response relation for dermal carcinogenicity of creosotes as derived by the SCTEE and the exposure model chosen by Germany, the calculated risk is several orders of magnitude lower than estimated by Germany. Depending on the exposure model selected, the risk is, however, slightly or more clearly above a value of 1 × 10ﬂ5, which is proposed as an acceptable risk level for genotoxic carcinogens in drinking water by the World Health Organisation. (95) The SCTEE also mentions that the figure of 2 ng B[a]P per kg bw/day as a worst-case exposure to B[a]P from playing on creosote-treated wood has to be compared to estimates for intake of B[a]P via food. Annual intakes of B[a]P from food has been estimated to be in the order of 0,3 to 1,6 mg, which would result in daily exposures of 12 to 63 ng/kg bw for a person weighing 70 kg (i. e. much higher than the dermal exposure). (96) Overall the SCTEE concludes: 1. - Given the the and the genotoxicity of B[a]P skin-application Fraunhofer outcome of study, there is sufficient scientific evidence to support the opinion that there is a cancer risk to consumers from creosote containing less than 50 ppm B[a]P and/or from wood treated with such creosote. - B[a]P is a good indicator for the carcinogenic hazard of the creosote preparation tested, since there was a linear relationship between cancer incidence and B[a]P dose. However, the cancer potency of the creosote preparation was five times higher than judged from its B[a]P content. into account 2. - On the basis of the available information, even considerable taking uncertainties in assessing the risks for children coming into contact with creosote-treated wood, the magnitude of the risk gives clear reason for concern. However, estimated the exposure is some 6 to 30 times lower than the highest the oral exposure of the adult population to B[a]P in food. - In order to get a better estimate of the exposure situation, one would have to perform a real-life, mass-balance study in exposed children. In addition to being very complicated and resource intensive, to conduct such a study would raise ethical questions. 3. 1. 5. Overall evaluation (97) Germany has neither claimed, nor could it be demonstrated through further research, that a specific situation exists in Germany with regards to the general pollution of the environment by PAHs, or the exposure of man and the environment to PAHs originating in the use of creosote and creosote-treated wood, or that this would be the case of Germany applied the provisions of Directive 94/60/EC. (98) However, the Commission has received additional information in the framework of similar requests from The Netherlands, Sweden, and Denmark for derogation the former Article from Directive 94/60/EC under 100a(4) of the EC Treaty, and new scientific evidence through an extensive the adoption of the Community Directive. study carried out after (99) Based on these most recent experimental data, the SCTEE has estimated that there is a cancer risk to humans from creosote containing less than 50 ppm B[a]P and wood treated with such creosote, the magnitude of which cannot be estimated with certainty. Taking into consideration the uncertainties concerning exposure, that measures aiming at reducing the probability of prolonged dermal exposure to creosote, either through direct contact with creosote or wood treated with creosote, are justified in the light of the precautionary principle. the Commission considers (100) The legislation notified to the Commission by Germany takes account of the general principle of proportionality, i. e. the measures do not seem to exceed what is suitable and necessary for the pursuit of the legitimate objective, as this legislation provides for the possibility to use creosote creosote when compatible with the needs for the protection of health and the environment. and products containing (101) In accordance with Article 95(7) of the Commission is already examining the appropriateness of the Treaty, 22. 12. 1999 EN Official Journal of the European Communities L 329/59 adapting to technical progress the provisions of Directive 94/60/EC regarding creosote. In addition, the Commission will evaluate the use of creosote under the review programme in Article 16 of established European Parliament and Council Directive 98/8/EC of 16 February 1998 on the placing of biocidal products on the market (28) in a time-frame compatible with the general timing of the review programme and taking into account other possible priorities identified when effectively setting up the programme. Furthermore, an ongoing research project under the fourth framework programme for research and technological development is reviewing the production chain and in-service life of poles treated with creosote (29). 3. 2. The absence of arbitrary discrimination (102) Article 95(6) obliges the Commission to verify that the national provisions are not a means of arbitrary discrimination. According to the ruling of the Court of Justice, the absence of discrimination means that no different treatment should be given to similar situations, nor similar treatment to different situations. (103) The limitations on marketing and use of products containing creosote in the German ordinances is based on their content of B[a]P: 5, 50 or 500 ppm. The restrictions apply without distinction to all products, whether in Germany or imported. The same applies for wood treated with preparations containing creosote. The Commission considers, therefore, that there is no evidence that the German regulations can be used as a means of arbitrary discrimination between economic operators in the Community. are manufactured they 3. 3. The absence of a disguised restriction on trade (104) More restrictive national measures in the area of limitations of marketing and use of products derogating from the provisions of a Community Directive do normally constitute a barrier to trade. Products that can the be legally placed on the market Community cannot be placed on the market in the Member States concerned. The concept enshrined in Article 95(6) the restrictions is intended to prevent based on the criteria of paragraph 4 being applied for inappropriate constituting economic measures introduced to impede the import of products from other Member States in order to protect indirectly national production. and in reality in the rest of reasons, (28) OJ L 123, 24. 4. 1998, p. 1. (29) Research contract framework FAIR5-CT98-3933 programme for RTD), Integrating the processes involved in the production of creosoted utility poles. (fourth to all examine available (105) The Commission mandated a study (30) to analyse the effects on trade and competition of the retention by Germany of its stricter national provisions. The study undertook information regarding the volume and value of trade with other the interest which Germany Member States affected, might have in using its national rules to promote a national interest in substitutes, and the interest which Germany might have in using its national rules to promote alternatives to creosote-treated wood. To this end, interviews took place with regulators in Germany, with industry representatives, and with the relevant industry associations. (106) According to the study, Germany imports all the total production of the creosote for domestic consumption (about 6 000 t). On the other hand, the only producer of creosote in Germany is exported (30 000 t, it is to be taken into mostly to the USA). However, account that export of creosote containing up to 500 ppm B[a]P is only permitted to countries with specific climatic conditions requiring enhanced wood protection. This means in practice the same that restrictions apply to exports as to the national market. Therefore the national legislation on creosote does not try to protect the national market by creating barriers to imports while allowing unrestricted exports. Germany also seems to import creosote treated timber; exact figures were, however, unavailable. (107) More recent and higher-value timber treatment biocides (like metal or boron salts) can substitute for creosote. These products are produced and imported in Germany in a similar manner to creosote. (108) It was established before that there is a real concern with regards to human health related to the use of creosote and treated timber. Therefore, the protection of health seems to be the real goal of maintaining the legislation, and not the creation of disguised national barriers to trade. (109) Overall, the Commission considers therefore that there is no evidence of a disguised restriction on trade between Member States provoked by the German ordinances concerning creosote. 3. 4. The absence of obstacles to the functioning of the internal market (110) This condition, which is established by Article 95(6), first subparagraph, is new in comparison with the text of the former Article 100a(4) of the EC Treaty. This (30) Environmental resources management, Trade and Competition assessment of the German and Danish request for derogations on the marketing and use of creosote, Final report, June 1996. L 329/60 EN Official Journal of the European Communities 22. 12. 1999 condition cannot be interpreted in such a way that it prohibits the approval of any national measure likely to affect the establishment of the internal market. In fact, any national measure derogating from a harmonisation measure aiming at the establishment and operation of the internal market constitutes in substance a measure that is likely to affect the internal market. Consequently, to preserve the useful character of the procedure for derogation provided for by Article 95 of the EC Treaty, the Commission considers that, in the context of the Article 95(6), the concept of obstacles to the operation the internal market has to be understood as a of disproportionate in relation to the pursued objective. effect (111) Germany asserts that the effects of the more restrictive German legislation on the functioning of the internal market can be considered to be small, and this for the following reasons: - tar-oils are unavoidable byproducts of the coking industry, having a low economic value. Major producers are located in Germany and the United Kingdom, - the parties most affected by the more stringent the German are national provisions producers, which clearly demonstrates the that national regulations have not been enacted as a means of economic discrimination or disguised restriction on trade. therefore (112) Germany further affirms there are no other measures possible which would have a smaller adverse effect on the functioning of the internal market while retaining a comparable level of protection. that (113) According to the study by ERM (31), the European creosote-production industry is characterised by the following features: - creosote is produced as a byproduct, not a primary one, - production exceeds consumption to a significant degree, - there are a small number of creosote producers, - there is a decline in demand. (114) Because of this situation, suppliers are generally willing the product specifications required by their to meet customers (if they can do so technically). (115) Producers of creosote are located in Germany, Austria, Italy, Belgium, Denmark, France, The Netherlands, Spain, and the UK. 90 % of creosote is used for the industrial impregnation of wood by professional wood preservation companies. The remaining 10 % of creosote is used by individual consumers, mostly in the UK and Ireland. (116) Professional impregnators primarily treat timber for use as telecommunications and power poles and railway sleepers. The composition of creosote varies according to the coal-tar feedstock used, the production method employed and the requirements of the customer. In fact, most of the large-scale users have developed their own detailed specifications in relation to boiling curves and in the specific the creosote. Most, but not all, of the producers can produce creosote containing less than 50 ppm B[a]P. concentration of components (117) Table 4 gives a survey of the situation with regard to location, producers of whether they can produce creosote with B[a]P content < 50 ppm and whether they have had trade with Germany. geographic creosote, their Table 4 Production, sales and trade in creosote in Europe (32) Country Number of producers Possibility of producing creosote with B[a]P < 50 ppm Sales of Creosote (tonnes/year) 1995 Trade with Germany Austria Belgium Denmark 1 1 1 No Yes Yes - 3 900 0 Yes No Yes (31) See footnote 30. (32) Source: see footnote 30, and: W. D. Betts, Study of the effects on trade and competition of the retention by The Netherlands of its national rules in place of the rules to be established by Directive 94/60/ECí, Tar Industries Services, Chesterfield (UK), December 1995. 22. 12. 1999 EN Official Journal of the European Communities L 329/61 Country Number of producers Possibility of producing creosote with B[a]P < 50 ppm Sales of Creosote (tonnes/year) 1995 Trade with Germany France Germany Netherlands Spain United Kingdom Italy Greece Ireland Sweden Finland 1 1 1 2 2 - - - - - Yes Yes Yes Yes/No Yes - - - - - 6 750 5 000 5 900 13 950 20 000 11 100 6 700 3 000 6 000 5 000 No - Yes No No No No No Yes Yes (118) Marketing and use of creosote have been regulated in Germany since 1991. The effect of the legislation has been mainly the elimination of the market for brush application (private consumers) and the introduction of restrictions on the professional market (treatment process, use of creosote containing less than 50 ppm B[a]P except for railway sleepers and electricity poles for export). could result from the fact that only wood treated with creosote containing less than 50 ppm B[a]P can be creosote imported, whereas wood containing up to 500 ppm B[a]P can be exported. However, the quantity of such wood exported seems to be very small. the study states that treated with (119) As a result the German creosote market is restricted to producers who are able to produce creosote with B[a]P level of < 50 ppm, which eliminated the Austrian creosote producer from the German market. Most of the producers in other Member States can comply with the German regulations. In fact, almost all domestically consumed creosote is imported from other Member States. A very small market for creosote containing up to 500 ppm B[a]P still seems to exist (exemption in the national is virtually unknown. for export) but this market regulations (120) Due to the restrictions, competition has increased and the margins have been lowered in creosote products for marketing and use within Germany. The decline in the market has mainly and disproportionately affected the German producer who had to reduce its creosote output, surplus output into lower value products such as carbon black feedstock and electrode pitch. This situation does not seem to have changed after the approval of Directive 94/60/EC. focus on export markets, re-direct (122) The market for railway sleepers has declined from a peak of 200 000 sleepers per year during the 1950s to approximately 30 000 sleepers per year in 1995. The main reason is the replacement by concrete as the increased mass of the sleepers is required for modern lines used by high-speed trains. The market for creosote-treated poles is also declining as salt treatment (power is transmission; telecommunication, agriculture). A review on behalf of the Federal Environment Agency into the German market for treated timber in 1992 concluded that about 2 million m3 of wood is used per year in Germany. 750 000 m3 is pressure treated with salt, which accounts for 70 to 90 % of the overall market for the treatment of wood. applications increasingly used all in to have declining (123) The market for the treatment of wood with creosote appears the been implementation of the German legislation, although the legislation appears to have accelerated the trend. Trends to use alternatives for the main applications of treated wood (railway sleepers and poles) had already existed before the implementation of the German regulations and were thus merely reinforced. prior to (121) In what concerns the creosote treated timber, there are some five companies treating wood with creosote (pressure/vacuum impregnation) and it is primarily used for and power/telecommunications poles. Market distortion in trade with treated wood railway sleepers (124) In conclusion, the direct volume and value of trade in creosote affected by German regulations is small since the use of creosote has already been effectively reduced. As the national legislation has been in place since 1991, L 329/62 EN Official Journal of the European Communities 22. 12. 1999 the maintenance of legislation after the the national approval of Directive 94/60/EC does not change the previously existing situation, which did not seem to have provoked significant distortions of the internal market for treated timber or for creosote. (125) Taking into account the preceding observations, the Commission considers that there is no evidence that the German provisions subject to this Decision constitute a disproportionate obstacle to the functioning of the internal market in relation to the pursued objectives. IV. CONCLUSION (126) of the the light above considerations, the In Commission is of the opinion that the provisions with regards to the use of creosote as notified by the Federal Republic of Germany pursuant to the former Article 100a(4) and examined under Article 95(4) and (6) of the EC Treaty: - fulfil the formal requirements of the said provisions and are to be admitted, (127) The Commission therefore has reason to consider that the national provisions notified can be approved, HAS ADOPTED THIS DECISION: Article 1 tar-oils, The provisions relating to marketing and use of contained in the Banned Chemicals Ordinance, section 17 appended to paragraph 1, and the Hazardous Substances Ordinance, paragraph 12 in conjunction with Appendix III, No 15, and paragraph 15 in conjunction with Appendix IV No 13, as notified on 4 July 1995 are approved. Article 2 This Decision is addressed to The Federal Republic of Germany. - can be considered justified on grounds of major need of protection of human health, Done at Brussels, 26 October 1999. - do not constitute either a means of arbitrary discrimination, a disguised restriction on trade a disproportionate between Member States, or obstacle to the functioning of the internal market. For the Commission Erkki LIIKANEN Member of the Commission