Report Lindane 0804...HCH a cumulative use of 259 000 tonnes α-HCH, 20 000 tonnes β-HCH, and 135...

Reports on Substances Scheduled for Re-assessments

Under the UNECE POPs Protocol

Technical Review Report on Lindane

August, 2004

Prepared by:

Ingrid Hauzenberger, Federal Environment Agency

Spittelauer Lände 5 A-1090 Wien, Austria

page 2/38

Executive summary Under the POPs Protocol to the Convention on Long Range Transboundary Air pollution the parties agreed in 1998 to reassess the production and use of lindane (see article 10 of the Protocol and the reassessment clause in annex II). This technical review serves this purpose and is a compilation of two surveys performed in 2001 and 2004 in the UNECE region. From 49 Parties or Signatories to the Convention 31 parties provided information via a ques-tionnaire concerning the production and use of lindane, including information of alternatives and control actions. Technical HCH and lindane are listed in Annex II of the Protocol under the agreement that technical HCH is restricted to use as an intermediate in chemical manu-facturing. Applications of lindane are restricted to the following:

1. Seed treatment 2. Soil applications directly followed by incorporation into the topsoil surface layer 3. Professional remedial and industrial treatment of lumber, timber and logs 4. Public health and veterinary topical insecticide 5. Non-aerial application to tree seedlings, small-scale lawn use, and indoor and outdoor use for nursery stock and ornamentals 6. Indoor industrial and residential applications

The condition stated in the Protocol is that all restricted uses of Lindane shall be reassessed no later than two years after entry into force. Because of its toxic, suspected carcinogenic, persistent, bioaccumulative and suspected en-docrine disrupting properties lindane became a substance of scrutiny and was flagged for regulatory intervention in the recent decades. Thenceforth production as well as marketed volumes steadily decreased. Any production seems to have been discontinued sometime in the mid nineties at the latest. Since no ongoing production could be identified in 2004 accord-ing to the responding countries for the UNECE region, it is concluded that all continuing uses of lindane products are based either on imported active substance or domestic stockpiles. Although not all Parties or Signatories to the Convention provided information, there is evi-dence that e.g. Romania still produces lindane. With the scheduled accession of Romania to the EU in 2007 and subjection to the recently adopted EC Regulation on POPs this produc-tion site will have to be closed down in the near future. Generally the new EU policy concerning POPs will have a major influence on the restricted uses of lindane as stated in the Protocol, as a complete phase out of lindane was decided in the framework of the EC regulation on POPs, which entered into force in May 2004. The stepwise procedures still allow the use for professional remedial and industrial treatment of lumber, timber and logs, and indoor industrial and residential applications until September 2006. Technical HCH for use as an intermediate in chemical manufacturing, as well as lin-dane containing products for public health use and as veterinary topical insecticide will be banned by 31 December 2007 at the latest. According to the survey in 2004 the major reported use of lindane was for public health and as a veterinary topical insecticide. Canada and US stated explicitly that pharmaceutical use of lindane in their countries is limited for the treatment of humans. The remaining countries, except Switzerland and Croatia, i.e. members of the EU (Austria, Czech Republic (only hu-man health), Germany, France, Ireland and UK) will be expected to terminate the uses for human health and for veterinary purposes by the end of 2007 according to the new EC regu-lation on POPs. Two EU-member countries (France and Spain) also reported indoor indus-trial and residential applications. Use of lindane for wood preservation (professional remedial and industrial treatment of lumber, timber and logs) is still practise in France. Since no non-EU-member country reported these application areas, use for indoor industrial and residen-tial applications, as well as wood preservation will also be terminated by 2006. A major use of lindane was historically for plant protection. However, only one Party to the Convention (US) responding to the 2004 questionnaire reported the use of lindane for seed treatment to be relevant. All other countries are in the stage of prohibition or had already in-terdicted all authorisation and use of lindane containing plant protection products.

page 3/38

In comparison to the result of the two survey concerning alternatives to lindane, 16 countries reported available and well known alternatives in 2004 compared to 5 countries in 2001. A comprehensive evaluation of these substitutes goes beyond the scope of this dossier. Sum-marising the result of the survey 2004 it was shown that the use of lindane is definitely re-duced and further steps are expected to be taken in the context of other international frame-works and strategies (OSPAR, NAFTA).

Introduction

Protocol Requirement In the framework of the UN-Economic Commission for Europe the Convention on Long Range Transboundary Air Pollution (LRTAP-Convention) was elaborated and signed by 49 parties. Since 1979 this instrument for the reduction of air pollution via transnational efforts was ratified by 33 signatories. In 1998 the Protocol on Persistent Organic Pollutants was signed in Aarhus and entered into force on 23 October 2004. Under the basic obligations of this protocol parties agreed to restrict the substances listed in Annex II to the uses described herein. In the past HCH was worldwide used for its pesticidal activity in various areas of application. The conditions stated in the protocol allow technical HCH as an intermediate in chemical manufacturing, whereas its gamma form, lindane, is restricted to 6 uses. The condition for these exceptions lies down that all restricted uses of lindane shall be reassessed until the 23 October 2006 (article 10 of the Protocol and the re-assessment clause in annexe II).

Chemical information Lindane is also known under the synonyms γ-HCH, γ-BHC, y-benzene hexachloride or y-hexachlor.1 Lindane is the active isomer among the eight stereoisomers of hexachlorocyclo-hexane.2 The minimum content of lindane for commercial use is usually equal or above 99.5 %. The value complies with the value set in the international specifications, e.g. FAO 4γ/TC/S (1990).3 γ-HCH can be converted into other HCH isomers in the environment, and also microorganisms and plants may convert γ-HCH into the alpha, beta or delta isomers.4

Chemical name (IUPAC) (1,2,4,5/3,6)- gamma stereo isomer of 1,2,3,4,5,6-hexachlorocyclohexane

Chemical name (CA) 1α,2α,3β,4α,5α,6β- hexachlorocyclohexane CAS No 58-89-9 EEC No 200-401-2 Molecular mass 290.82 Structural formula

ClH

H

HCl

HHCl

ClClH

Cl

1 Maryadele, J., Smith, A:, Heckelman, P., Obenchain, J., Gallipeau, J., Arecca, M. (Edit.) (2001): The Merck Index. Merck & Co., INC. USA, 13. Edition, p. 986. 2 Hornstein, I. (1955): Nomenclature and structure of 1,2,3,4,5,6-hexachlorocyclohexanes. Science, Feb 11;121(3137) p. 206-7. 3 Food and Agriculture Organization of the United Nations (1990): LINDANE - Specifications for Plant Protection Products. FAO, Rome. 4 Roberts, T., Huston, D.(2002): Metabolic Pathways of Agrochemicals. Royal Society of Chemistry, Cambridge, UK, p. 171.

page 4/38

Classification: 5

EU-Classification T (toxic), Xi (irritating), N (environmentally dangerous) R23/24/25 Toxic by inhalation, in contact with skin and if swal-

lowed R36/38 Irritating to eyes and skin R50/53 Very toxic to aquatic organisms, may cause long-term

adverse effects in the aquatic environment

Methodology The Executive Body, at its seventeenth session, decided to establish an Expert Group on POPs for the further assessment and technical review of the Protocol on POPs. In this con-text Austria (with contribution from Ms. Barbara Perthen-Palmisano, Federal Ministry of Agri-culture, Forestry Environment and Water Management) and Germany (Michael Herrmann, Federal Environment Agency, Berlin) volunteered to prepare jointly an information dossier on lindane in July 2002 based on a questionnaire, which was circulated and distributed in De-cember 2001 to 50 parties. 25 countries responded. Following the entry into force of the protocol, the Executive Body for the Convention estab-lished the Task Force on POPs at its twenty-first session in December 2003. The technical report takes the up-dated result from the distributed questionnaire in March 2004 into con-sideration as well as current decisions regarding lindane under other international regula-tions. It was assumed that no changes occurred concerning the status of lindane in countries which provided information in 2001 but did not respond to the questionnaire in 2004 (see Annex III for details of responding parties).

Production Historical production sites of technical HCH and/or lindane can be found in many European Countries including the Czech Republic, Spain, France, Germany, UK, Italy, Romania, Bul-garia, Poland and Turkey (Annex I, table I-1). Production in the UNECE Member Countries took mainly place from 1950 or earlier to 1970 and stopped in 1970 to the 1990s. Only rough estimates on years of production and on produced volumes could be made available, if at all. Rhone Poulenc in France and Inquinosa in Spain run the last sites in Western Europe to close down production. Outside Europe manufacturers and suppliers of lindane were also located in the US. In 1978 the US EPA set an end to the production of technical HCH, 6 years ago Canada’s manufacturer voluntarily discontinued the production of this compound.6 Worldwide production volumes decreased steadily, figures are given in table 1. Table 1: Production of lindane7 Tonnes per year Production world-wide 19868 approx. 38 000 World Production 1988-19939 4 400 World Production 1990-1995 3 222 Production in Western Europe in the 90s approx. 2 055 Production in the EEC (1991) 10 1 000 – 5 000

5 Commission Directive 93/72/EEC of 1 September 1993 adapting to technical progress for the nineteenth time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. Official Journal L 258 , 16/10/1993. p. 29 – 30. 6 North American Commission for Environmental Cooperation (2000): Decision Document on Lindane. 7 Hazard Substances Committee of OSPAR Convention (2002): OSPAR Background Document on Lindane. 8 IUCLID (1994): International Uniform ChemicaL Information Database. 9 Deutzler, A. (1998): Investigation of emissions and abatement measures for persistent organic pollutants in the Federal Republic of Germany. Umweltbundesamt Berlin, UBA Text 75/98; p.291.

page 5/38

The trend of the historical production of lindane can also be interlinked with decreasing us-age volumes and pattern. The use of technical HCH was the major source of γ-HCH until the late 1970s. Thereafter lindane became the major source of this isomer, though during the production process α-HCH is a major by-product.11 EU-Directive 79/117/EEC caused a ban of technical HCH (< 99 % of γ-isomer) in 1979 within EU Member States.12 From data gathered within the ‘Popcycling-Baltic’ project it was suggest that a total of 382 000 tonnes of technical HCH and 81 000 tonnes of lindane were used in Europe from 1970 to 1996. Assuming a technical HCH pattern of 65 – 70 % α-HCH, 10 % β-HCH and 15 % γ-HCH a cumulative use of 259 000 tonnes α-HCH, 20 000 tonnes β-HCH, and 135 000 ton-nes γ-HCH were estimated for this time period.13 Other estimates for global usage of lindane report a drop from 11 900 tonnes in 1980 to 8 400 tonnes in 1990.14 According to C.I.E.L (Centre International D Études Du Lindane), an association of lindane manufacturers from France, China, India and Spain which supported the review of lindane under the EU Plant-Protection-Product-Directive (91/414/EEC), the average annual lindane consumption in Europe was 2 130 tonnes from 1992 to 1997. France was a major user of lindane in Europe at that time with an annual average consumption rate of 1 600 tonnes/yr.13 In the United States, estimates of annual usage of lindane between 1980 and 1990 show a decrease from 268 to 114 tonnes/a. During this same period, Canada's usage increased from 200 to 284 tonnes/a.15 From 1996 to 2001 the weighted average of lindane used for seed treatment in US was 65 tonnes/a.16 According to the survey among UNECE countries in 2001 and 2004 no ongoing production could be identified and therefore it is concluded that all continuing uses of lindane products are based either on imported active substance or domestic stockpiles. Although no data were submitted from e.g. Romania and the Russian Federation, there is evidence that Romania still produces lindane.17 Other worldwide production sites of lindane are located in India, China and Japan.18 Concerning trade connections Spain, UK, Canada and the US declared, according to the UNECE survey 2004, that lindane is imported to their countries. Figures, if available at all, ranged up to 105 tonnes/a (US). Up to 2001 the estimation of exported lindane formulated in plant protection products from the US mainly to Canada is about 500 tonnes/a. However these numbers are likely to have been an overestimation according to the result of the 2004 questionnaire.

Use Lindane is an insecticide which acts by contact, ingestion and fumigation. It has been used on a broad range of applications among which the most important ones are in agriculture, horticulture and forestry (for seed treatment and for control of a broad spectrum of phyto-phagous and soil-inhabiting insects and as ectoparsiticide for livestock). Lindane was used in plant protection products as an insecticide for a wide variety of crops including seed treat-ment and fumigation.

10 Rippen, G. (1990/2000): Umweltchemikalien: Stoffdaten, Prüfverfahren, Vorschriften. Ecomed: Lands-berg/Lech; 3. Aufl., Loseblattsammlung, Aktualisierung 5/2000; ISBN 3-606-73210-5. 11 World Health Organisation (1992): Environmental Health Criteria, WHO, 123:1-66. 12 Council Directive 79/117/EEC of 21 December 1978 prohibiting the placing on the market and use of plant protection products containing certain active substances. Official Journal L 033 , 08/02/1979 p. 36 –40. 13 Breivik, K.; Pacyna, J.M.; Münch, J. (1999): Use of α-, β- and γ-hexachlorocyclohexane in Europe 1970-1996. Sci. Total Environ. 239: p. 151-163. 14 Li, Y.F.; McMillan A; Scholtz M.T. (1996): Global HCH/Lindane usage with1°x1° longitude/latitude resolution. Environ. Sci. Technol. 30: p. 3525-33. 15 North American Commission for Environmental Cooperation (2000): Decision Document on Lindane. 16 US EPA (2002): Reregistration Eligibility Decision for Lindane. CASE 315. 17 NAFTA - North American Regional Action Plan on Lindane (2003): Background Document on lindane. 18 PAN UK (1995): Lindane, a chemical of the past persists in the future. Pesticides News No.28: p 28-29.

page 6/38

Also its use as a biocide (e.g. preservation of wood, leather etc. including indoor applica-tions) as well as an insecticide for medical or veterinary treatment has been widespread in industrial and developing countries. Also in the light of the lack of comparable alternatives the POP protocol restricted the uses of lindane in 1998 to the following: 1. Seed treatment 2. Soil applications directly followed by incorporation into the topsoil surface layer 3. Professional remedial and industrial treatment of lumber, timber and logs 4. Public health and veterinary topical insecticide 5. Non-aerial application to tree seedlings, small-scale lawn use, and indoor and out door use for nursery stock and ornamentals * 6. Indoor industrial and residential applications As a milestone and as a consequence of the problematic properties of lindane the EU de-cided a complete phase out of lindane by the EC regulation on POPs (EC 850/2004), which lists lindane in Annex I).19 Thus the production, marketing and use of HCH/lindane is prohib-ited. By way of derogation, Member States may allow:

• Until 1 September 2006: o professional remedial and industrial treatment of lumber, timber and logs, and o indoor industrial and residential applications;

• Until 31 December 2007: o Technical HCH for use as an intermediate in chemical manufacturing; o Products in which at least 99 % of the HCH isomer is in gamma form (lindane)

are restricted for use as public health and veterinary topical insecticide. The Regulation allows the use of technical HCH and lindane for laboratory scale research and as a reference standard only. The below compilation and analysis of the results of the questionnaire 2004 (Annex I, table I-2) and other relevant international actions regarding lindane were clustered according to the different application areas.

Agriculture In the European Union by Commission Decision 2000/801/EC concerning the non-inclusion of lindane in Annex I to Council Directive 91/414/EEC, the withdrawal of authorisations for plant protection products containing this active substance started.20 Any period of grace for disposal, storage, placing on the market and use of existing stocks of plant-protection prod-ucts containing lindane allowed by Member States was limited to a period of no longer than 18 months to allow existing stocks to be used in no more than one further growing season. That means application of lindane for agricultural uses in the EU was discontinued in mid 2002. In several Member States and other European countries authorisation of lindane prod-ucts for agricultural applications expired already in former years. Lindane was subject for re-registration under die Federal Insecticide, Fungicide and Rodenti-cide Act (FIFRA) for agricultural as well as pharmaceutical use in the US. The re-registration eligibility decision for Lindane restricts use to pre-plant seed treatment on barely, corn, oats, rye, sorghum, wheat and possibly canola.21 The average and the maximum annual tonnage are given with 66 to 106 mt/a (including around 1 mt/a for pharmaceutical use). Though 1998 Canadian registrants agreed to undertake voluntary reduction initiatives the Canadian Pest Management Regulatory Agency announced a special review of pest control

19 Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC. Official Journal L 158 , 30/04/2004 p. 0007 - 0049 20 European Commission Decision 2000/801/EC of 20 December 2000 concerning the non-inclusion of lindane in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant-protection products containing this active substance. Official Journal L 324, 21/12/2000 p. 42 –43. 21 US EPA (2002): Office of Pesticide Programs, Lindane Reregistration Eligibility Decision. [http://www.epa.gov/oppsrrd1/REDs/lindane_red.pdf].

http://www.epa.gov/oppsrrd1/REDs/lindane_red.pdf

page 7/38

products containing lindane. The review resulted in a prohibition of the last remaining appli-cations of lindane for seed treatment by the end of 2004.22 Thus the US is the only country which reports usage of lindane for seed treatment after 2004. The use of lindane for non-aerial application to tree seedlings, small-scale lawn use, and indoor and outdoor use for nursery stock and ornamentals was no longer supported by any responding country. Also soil applications directly followed by incorporation into the topsoil layer can be considered of no relevance any more.

Biocide and other applications Lindane products have been also used for hygiene purposes as well as to enhance durability of materials like wood, leather, wool, cotton etc. by protecting from insect infestation. The EU regulates non-agricultural insecticides, acaricides and products to control other arthropods under the Biocidal Products Directive 98/8/EEC.23 An informal list of biocidal substances communicated by the European Chemicals Industry to the Commission of the EU includes applications of lindane for purposes of wood preservation, preservation of liquid-cooling and processing systems, rodenticides and insecticides, acaricides and products to control other arthropods.24 According to the 2nd EU-Review Regulation lindane was notified as veterinary hygiene biocidal product in 2002.25 As a consequence all other biocidal uses would be pro-hibited by September 2006. These restrictions were also reflected in the step-wise phase-out of lindane in the EC regulation on POPs. Thus the reported lindane treatment of lumber, timber and logs by France will be terminated in 2006. However, this does probably not set an end to the commerce with imported lindane-treated articles on the EU-market. For indoor industrial and residential applications, which were only reported by France and Spain, the above mentioned will also apply. UK revoked all non-agricultural uses of lindane setting step-wise revocation periods for products which expired by the latest of January 2004. Responding countries reported no other types of uses besides the ones mentioned under the protocol in the questionnaire.

Public health and veterinary topical insecticide Lindane is used to control ectoparasites of humans (head lice, scabies) and of domestic animals. In ten responding countries in 2004 lindane-containing preparations are still allowed to be marketed for these purposes: Austria, Canada, Croatia, Czech Republic, France, Ger-many, Ireland, Switzerland, UK and the US (see Annex I, table I-2). Several scabicide and pediculicide products containing lindane are registered in Canada under the Food and Drug Act. Sale and distribution of registered products has been discontinued by the manufacturers for veterinary topical uses. 26 Also no veterinary topical insecticides containing lindane are registered in the US. Under the US Food and Drug Administration lindane was labelled as a second line therapy in 2003 after a review by the Agency. However according to the US-EPA re-registration of lindane it cannot be concluded that exposure through scabies treatment will not result in unacceptable exposure and risk for human health.27 In 2002 California prohibited products for the treatment of lice or scabies in human beings that contains the pesticide lin-

22 Pest Management Regulation Agency (2002) Update on the Special Review of Lindane and the Status of Lin-dane, Health Canada. 23 Commission Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market. Official Journal L 123. 24/04/1998 p. 0001 – 0063. 24 CEFIC (12.07.2000) Provisional Lists of biocidal active substances, [http://ecb.ei.jrc.it/Biocidal-List] 25 COMMISSION REGULATION (EC) No 1896/2000 of 7 September 2000 on the first phase of the programme referred to inArticle 16(2) of Directive 98/8/EC of the European Parliament and of the Council on biocidal prod-ucts, Official Journal of the European Communities 8.9.2000 L 228/6. 26 Database Health Canada (2002) [http://search.hc-sc.gc.ca/cgibin/query?pg=q&fmt=.&q=lindane]. 27 USEPA (2002) Office of Pesticide Programs, Lindane Reregistration Eligibility Decision. [http://www.epa.gov/ oppsrrd1/REDs/lindane_red.pdf].

http://ecb.ei.jrc.it/Biocidal-List

http://search.hc-sc.gc.ca/cgibin/query?pg=q&fmt=.&q=lindane

http://www.epa.gov/

page 8/38

dane from being used or sold in the state.28 Also currently New York State proposes legisla-tion banning the sale, use, and prescription of lindane.29 Although lindane-containing products are allowed to be on the market, some countries ex-pressed their uncertainty if the use of this products reflects adequately the current practise. According to literature development of head lice resistant to therapies, including lindane, permethrin and malathion, has become a worldwide problem. Resistance to organochlorine insecticides (e.g. lindane) has been observed in Great Britain, the Czech Republic, France, Canada, Denmark and the US.30 Also resistance to commonly used scabicides became a major problem in recent years. To a considerable extent, the law of the country dictates the prescribing pattern. E.g. in the UK permethrin has replaced lindane which is according to literature data no longer available.31 There is no reason in the light of the poor pediculicidal and ovicidal activity for keeping lindane on the market in the United States, where lindane resistance has been documented. 32 Other experts on epidemics deem lindane products to be an indispensable tool for safe control of emerging resistant strains. Rotational therapy, using different agents, may help to slow the emergence of resistance.33 According to the new EC regulation on POPs lindane will be phased out in 2007 for human health and veterinary purposes.

Actions to control production and use According to the result of the survey 2004 all UNECE parties take national actions for use and/or production of lindane. Some countries differentiated the status according to different application areas. The current registration status of lindane was reported as limited author-ised by 11 countries, whereas the majority of 20 countries claimed a total ban. The manda-tory actions ranged from restrictions, prohibitions and exemptions (see Annex I, table I-3).

Other information

Alternatives for the use of lindane Reflecting the current national and international trend concerning the restriction and prohibi-tion of lindane a major issue is the availability of alternatives. In comparison to the question-naire circulated in 2001 to UNECE parties in 2004, 16 of the responding countries provided information. In 2001 only 5 countries reported alternatives in the questionnaire. For the time being a detailed evaluation of alternatives in the light of a comprehensive cost-benefit analy-sis goes beyond the scope of this dossier and will possibly be dealt at a later stage. An overview of alternatives is given in table 2. Table 2: Compilation of reported alternatives Use Active substances

Seed Treat-ment

pyrethroids, imidacloprid, fipronil, isofenphos, thiameth-oxan, clothianidin

Agriculture

Soil applica-tion

benfuracarb, furathiocarb, carbosulfan, aldicarb, terbufos, carbofuran, fenitrothion, tefluthrin, chlorpyrifos

28 California Law (2000): California Lindane Prohibition. BILL NUMBER: AB 2318. 29 PRWEB (15.4.2004): New York Follows California to Ban Prescription Pesticide Lindane for Lice and Scabies [http://www.prweb.com/releases/2004/2/prwebxml103521.php]. 30 Eichenfield, L.F., Colon-Fontanez, F. (1998): Treatment of head lice. Pediatr. Infect. Dis. J 17(5) 419-20. 31 Roos, T.C., Alam, M., Roos, S., Merk, H.F. Bickers D.R. (2001): Drugs. 61(8) 1067-88. 32 Meinking, T.L., Entzel P., Villar M.E., Vicaria M., Lemard G.A. Porcelain, S.L. (2001): Comparative efficacy of treatments for pediculosos capitis infestations: update 2000. Arch. Dermatol. 137 (3):287-92. 33 Elston, D. M. (1999): What´s eating you? Pediculus humanus. Cutis 63 (5) 259-64.

http://www.prweb.com/releases/2004/2/prwebxml103521.php

page 9/38

Use Active substances Unspecified

use diazinon, alpha-cypermethrin, beta-cyfluthrin, carbosulfan, methiocarb, ops, chloronicotinyls

Public Health and veterinary medicine

permethrin, tetramethrin, pyrethrins, d-phenothrin, malathion, diazinon, fenitrothion, alpha-cypermethrin, ben-diocarb, crotamiton, (ivermectin, benzyl benzoate)34

Wood preservation pyrethroids, cypermethrin, permethrin Household deltamethrin, organophosphates, carbamates Water treatment bactoculicidum Unspecified use organophosphates, synthetic pyrethroids, neonicotinoides Detailed information on alternatives for pharmaceutical uses of lindane in the US and Can-ada are listed in table 3 (for pesticidal uses see Annex IA). Canada also provided information on “natural” alternatives to lindane for the lice treatment, as follows: Wet combing, formic acid preparations, topical vinegar and mineral oil, tea tree oil, acetic acid, citronella oil, cam-phor, sodium lauryl ether sulfate (SH-206). Table 3: Alternatives to lindane in the US and Canada Use Canadian Alternatives US Alternatives Head Lice Treatment Permethrin, Pyrethrin

and piperonyl butoxide Pyrethrum/Piperonyl Butoxide, Permethrin Malathion

Scabies Treatment Permethrin, Precipi-tated sulfur 6% in pet-rolatum

Permethrin, Crotamiton (Eurax)

Other international activities Lindane is also subject to bilateral and multilateral international agreements and treaties. In 1998 lindane was on the list of chemicals for priority action under OSPAR (Convention for the protection of the marine environment of the north-east Atlantic) and thus a background document was prepared under the lead of Germany in 2002.35 As a follow up, relevant ac-tions included cooperation with international bodies, promotion of severe restrictions, sug-gestions of lindane as a candidate for the Stockholm POP Convention and a proposal of a monitoring strategy. Moreover, considerations for OSPAR action on remaining uses were discussed. Following the latest discussion of the Working Group on Substances and Point and Diffuse Sources, emissions from this remaining uses for the OSPAR region were esti-mated to be in the range of a few tonnes per year including pharmaceutical use of several kilograms. For the time being and taking into account the new EC Regulation on POPs it was decided that a clear recommendation to OSPAR 2004 is not necessary at the moment.36 Under the North American Free Trade Agreement (NAFTA) lindane is undergoing a joint re-registration review between the US and Canada. Also, under the NAFTA environmental side agreement, the US, Canada, and Mexico decided to develop a North American Regional Action Plan (NARAP) on lindane, which started in 2002.37 Lindane is also subject to the PIC procedure according the Rotterdam Convention on Prior Informed Consent (PIC), a procedure for certain hazardous chemicals and pesticides in in-ternational trade, which entered into force in February 2004. 34 O´Brien, S. (2003): Lindane-Free Scabies Prevention and Treatment . Purchasing for Pollution Prevention Programm Fact Sheet, Inform [http://www.informinc.org/fs_no_lindane_scabies.pdf]. 35 OSPAR Commision (2002): Background Document on Lindane, Germany, ISBN: 0946956944. 36 OSPAR (2003): Working Group on Substances and point and diffuse sources (SPDS). Summary Record, Meeting Saariselkä 1-5. 12. 2004, SPDS03/16/1-E. 37 North American Commission for Environmental Cooperation (2002): Council Resolution 02-07: Developing a North American Regional Action Plan (NARAP) on Lindane, [http://www.cec.org/pubs_docs/docu-ments/index.cfm?ID=859&varlan=english].

http://www.informinc.org/fs_no_lindane_scabies.pdf

http://www.cec.org/pubs_docs/docu

page 10/38

Concluding remarks on the production and use of lindane relative to annex 2 of the Protocol Lindane was widely used as an insecticide until the 1990s in almost all countries of the UN-ECE. Because of its toxic, suspected carcinogenic, persistent, bioaccumulative and sus-pected endocrine disrupting properties lindane became a substance of scrutiny and was flagged for regulatory intervention in the recent decades. Thenceforth production as well as marketed volumes steadily decreased. Any production seems to have been discontinued sometime in the mid nineties at the latest in the UNECE region. Although not all countries of the UNECE region responded to the survey, there is evi-dence that Romania still produces lindane.38 With accession to the EU in 2007 and subjec-tion to the EC Regulation on POPs the Romania production site will have to be closed down in the near future. Under the agreement of the Protocol on Persistent Organic Pollutants lindane is restricted to six uses. In fulfilling the rules of procedures these restrictions should be reviewed no later than 23 October 2006, two years after the date of entry into force. In total 31 Signatories to the Protocol provided information for the surveys 2001 and 2004 (out of 49 Parties or Signatories to the Convention, April 2004). The new EU policy concerning POPs will have a major influence on the restricted uses, as a complete phase out of lindane was decided in the framework of the EC Regulation on POPs. The stepwise procedures still allow the use for professional remedial and industrial treatment of lumber, timber and logs, and indoor industrial and residential applications until September 2006. Technical HCH for use as an intermediate in chemical manufacturing, as well as prod-ucts, in which at least 99 % of the HCH isomer is in gamma form (lindane), for public health use and as veterinary topical insecticide, will be banned by 31 December 2007 at the latest. According to the survey in 2004 the major reported use of lindane was for public health and as a veterinary topical insecticide. Canada and US stated explicitly that lindane is used only pharmaceutically for treatment of humans. The remaining countries, except Switzerland and Croatia, i. e. members of the EU (Austria, Germany, Czech Republic (for humans only) France, Ireland and UK), will be forced to terminate this authorisation by September 2007 according to the new EC regulation. Two EU-member countries (France and Spain) also supported indoor industrial and residen-tial applications. Lindane for wood preservation (professional remedial and industrial treat-ment of lumber, timber and logs) is still practise in France. No other country reported these application areas. Though a major use of lindane was historically for plant protection, the only remaining coun-try, after 2004, will be the US, which claimed the use for seed treatment as relevant. All other countries are in the stage of prohibition or had already interdicted all authorisation and use of lindane containing plant protection products. In comparison to the result of the survey in 2001 concerning alternatives to lindane, 16 coun-tries reported available alternatives. It can be concluded that the status of lindane among other pesticidal active ingredients be-comes less important and it appears that alternatives and technologies can fully substitute the usage of lindane concerning the restricted uses. However, a comprehensive evaluation of these substitutes goes beyond the scope of this dossier. Lindane will be subject of other national and international activities e.g. OSPAR, NAFTA and further knowledge on adverse effects, restrictions and regulations can be expected.

38 NAFTA (2003): North American Regional Action Plan on Lindane, Background Document on lindane.

page 11/38

Annex I: Result of the survey in the UNECE region 2004 Table I-1: Information on the production and volume of lindane, part 1 of the questionnaire 2004 Question Country

D2: Is lindane presently produced in your country? D3: In what quantity?

D4: Was lindane ever produced in your country? D5: Estimated years in which production took place?

D6: Is lindane presently imported in your country? D7: In what quantity

D8: Is lindane currently exported from your coun-try? D9: In what quantity

Comments /Source of information

ARMENIA No No No No Lindane is not included in the “List of plant protection chemical and biological substances allowed for use in Republic of Armenia” approved by the Minister of Agriculture decree (No198-N on No-vember 18, 2003); this means that lin-dane import/export and use in Armenia is banned

AUSTRIA No No Unknown No BELGIUM No No No No BULGARIA No Yes

19xx to 1966

No No Lindane is banned with Order of the Minister of Agriculture and Forestry, Minister of Health and Minister of Envi-ronment and Water

CANADA No No Yes Unknown CROATIA* No No No No CZECH RE-PUBLIC

No Yes

1974 - 1977

No No National POPs Inventory. 61 680 t of lindane was produced based on the available information + probably more than 60 000 t of technical HCHs

CYPRUS No No No No DENMARK No Unknown No FINLAND No No No No FRANCE No GEORGIA* No No Unknown No GERMANY No Yes No No IRELAND No Unknown Unknown Unknown

page 12/38

Question Country






ITALY No Yes

Unknown

Unknown No

KAZAKH-STAN*

No No Unknown No

LATVIA No No No Unknown Lindane has been used or imported in Latvia from 1995 to 1999. Source of the information: Data base on chemical substances and chemical products (Latvian Environment Agency, 1995-2000).

LITHUANIA No No No No Banned import, production and use of pesticides containing this active sub-stance from 1997.Lithuanian Hygienic Standard HN 63:2003 „Banned and restricted pesticides“

MOLDOVA* No No No No MONACO* No Unknown No No NETHER-LANDS

No Unknown No No

NORWAY No No No No

page 13/38

Question Country






POLAND No Yes

App. 1955- 1985

from 1975 app. 300 mt/a

No No At present the use, marketing and recy-cling of HCH and lindane are prohibited in Poland. Source of information: Information from the former producer. Strategy on emis-sion control of persistent organic pollut-ants (2000, 2001). Statistical Annual Books of the Chemical Industry Regulation of the Minister of Agriculture and Rural Development of 5 March 2002 on detailed rules for granting permits for marketing and use of plant protection products (Dz. U. 2002, No. 24, item 250) (Annex 9. Bioactive sub-stances, contained in plant protection products, which are prohibited from use in Poland). Act of 27 April 2001 on En-vironmental Protection Law (O.J. 2001, No. 62, item 627; as amended) with its executive acts (regulations). Regulation of the Minister of the Environment of 9 December 2003 on substances posing special environmental threats (Dz.U. 2003, No. 217, item 2141)

SLOVAKIA* No No No No SPAIN* No Yes

Not available Yes

Not available No

SWEDEN No No No No SWITZER-LAND

No Unknown Unknown No

TURKEY No Yes No No UK Unknown Unknown Yes Unknown

page 14/38

Question Country






US No Yes

Estimated from 1950s - 1970s

Yes

Up to 105 mt/a

Yes ##

0-25 mt/a ###

FDA, 2004. Personal communication from Abigail Jacobs, Food and Drug Administration, to Mark Howard, USEPA, February 11, 2004. # This number is based on estimated amount of active ingredient used for lindane treated seed in the US. Less than one metric ton of pharmaceutical grade lindane is used annually. (FDA, 2003) ## The lindane active ingredient is not currently manufactured in the US. The lindane active ingredient is imported into the US and formulated into pesti-cide products. Some of these pesticide products are exported. USEPA, 2002. Some technical lindane is also re-exported. USEPA 2004. ### A wide range of estimates is avail-able. Numbers range as high as 500 metric tons/year. However, these num-bers are likely to have been an overes-timation. At this time the best guesses range from 5 – 20 metric tons/year. The amount was higher in the 1990s but by how much is not certain at this time. USEPA, 2004.

* country responded only in 2002

page 15/38

Table I-2: Information on the use of lindane, part 2 of the questionnaire 2004 Question Country

D10: Is lin-dane currently used in your country? D11: In what quantity?

D12: Use of lindane as a seed treatment D13: Soil applications directly followed by incorporation into the topsoil surface layer?

D14: Professional remedial and indus-trial treatment of lum-ber, timber and logs? D15: Public health and veterinary topical insecticide

D16: Non-aerial application to tree seedlings, small-scale lawn use, and indoor and outdoor use for nursery stock and ornamentals D17: Indoor industrial and residential applications

D18: Other types of uses for lin-dane in your country?

Comments/Source of information

ARMENIA No - - - - AUSTRIA Yes D12/13: No longer rele-

vant D14: No longer rele-vant D15: Yes

D16/17: No longer relevant Unknown Information on the use of lindane in wood preservative is scarce. Lindane could theoretically be on the Austrian market in wood pre-servatives (“grew market”). Lindane is used for medical treat-ment in various products (source: Austria Codex 2000/2001). 2 prod-ucts (Jacutin gel and Jacutin emul-sion) are registered for the treat-ment of scabies in humans. Furthermore lindane acts in veterinary drugs against lice, ticks and mange mites. Currently 4 veterinary products are registered in Austria. Lindane was also used as insecticide for pest control in non-agricultural products. The use of lindane in stock protection and pest control in household is prohib-ited since 1993. Furthermore lin-dane was prohibited as active in-gredient in antifoulings in 1990

BELGIUM No - - - - BULGARIA No - - - - Lindane is banned with Order of

the Minister of Agriculture and Forestry, Minister of Health and Minister of Environment and Water

page 16/38

Question Country







CANADA Yes D12/13: No longer rele-vant

D14: No longer rele-vant D15: Yes

D16/17: No longer relevant No Sale of agricultural products by registrants ended in 2002. It is expected that retail sale and use of virtually all existing stocks will end by 2004. Lindane is not permitted for veteri-nary use (topical applications) in Canada

CROATIA* Yes Estimates not available

D12/13: No longer rele-vant


D16/17: No longer relevant No

CZECH RE-PUBLIC

Yes D12/13: No longer rele-vant


D16/17: No longer relevant Unknown National POPs Inventory Information from expert of Ministry of Agriculture of the Czech Repub-lic; Information from expert of Min-istry of Health of the Czech Repub-lic; State Institute for drug control: product used for human health: Jacutin (from 1999), Skabicid (from 1996)

CYPRUS No - - - - DENMARK No - - - - FINLAND No - - - - The use of lindane as pesticide

was ended in late 1980's. The use in wood preservatives has been ended before 1990, because no products containing lindane have been authorised as wood pre-servatives. Lindane is not anymore used in medicines or veterinary medicines, either.

FRANCE Yes D12/13: No longer rele-vant

D14/15: Yes D16: - D17: Yes

Yes Used in veter. medicine and other veter. products

page 17/38

Question Country







GEORGIA* No - - - - GERMANY Unknown D12/13: No longer rele-

vant


D16/17: No longer relevant

Unknown Although the German Chemicals Act has introduced an authoriza-tion regime for biocidal products in 2002, this provision does not apply to “old” biocidal products as those containing lindane. . Owing to this situation it cannot be definitely excluded that there still is some ongoing use of lindane, e.g. from imported wood preservatives. A minor scale use of lindane is still been practiced in Germany for public health purposes in Ger-many. Therapy of head lice and scabies may be administered by public health authorities, involving lindane-based products.

IRELAND Yes D12/13: No longer rele-vant



No Authorised for use as treatment for prevention of head lice infestation in public health protection pro-grammes and for one veterinary medicine application (specific indication in the ear canals of dogs). ITALY No D12/13: No longer rele-

vant

D14: Unknown D15: No longer rele-vant

D16/17: Unknown

Unknown The use of Lindane as pesticide is banned in Agriculture (see D27). The normative for its use as bio-cide is under definition.

KAZAKH-STAN*

No D12/13: Unknown D14/15: Unknown D16/17: Unknown No

page 18/38

Question Country







LATVIA No D12/13: Unknown D14/15: Unknown D16/17: Unknown Unknown Data base on chemical substances and chemical products (Latvian Environment Agency, 1995-2000). Regulations of the Cabinet of Min-isters No.107 “Regulation Regard-ing Prohibited Plant Protection Products” (21.03.2000).

LITHUANIA No - - - - Banned import, production and use of pesticides containing this active substance from 1997.Lithuanian Hygienic Standard HN 63:2003 „Banned and restricted pesticides“

MOLDOVA* No D12/13: Unknown D14/15: Unknown D16/17: Unknown Unknown MONACO* No - - - - NETHER-LANDS

No - - - -

NORWAY No - - - -

page 19/38

Question Country







POLAND No - - - - The use of HCH/lindane is not permitted in Poland. For additional information – see D. Part 1. above Source of information: Information from the former producer Data from the Ministry of Agricul-ture and Rural Development. Regulation of the Minister of Agri-culture and Rural Development of 5 March 2002 on detailed rules for granting permits for marketing and use of plant protection products (Dz. U. 2002, No. 24, item 250) (Annex 9. Bioactive substances contained in plant protection prod-ucts, which are prohibited from use in Poland). Act of 27 April 2001 on Environmental Protection Law (O.J. 2001, No. 62, item 627; as amended) with its executive acts (regulations). Regulation of the Minister of the Environment of 9 December 2003 on substances posing special environmental threats (Dz.U. 2003, No. 217, item 2141).

SLOVAKIA* No - - - - SPAIN* Yes

Not available



D16: No longer relevant D15: Yes

No

SWEDEN No - - - - The Swedish Products Register

page 20/38

Question Country







SWITZER-LAND

Yes < 1 t/a




No

TURKEY No - - - - - UK Yes D12: Yes

D13: No longer relevant

D14: Yes D15: Yes

D16: Yes D17: Yes

Unknown Correction: All plant protection uses of lindane were withdrawn in 2002. Similarly, approvals for non-agricultural uses of lindane, such as treatment against woodworm, were also revoked.

USA Yes Avg 66 t/a, max. 106 t/aa

D12: Yes D13: No longer relevant

D14: No longer rele-vant D15: Yesb

D16/17: No longer relevant No USEPA, 2002. Office of Pesticide Programs, Lindane Re-registration Eligibility Decision. http://www.epa.gov/oppsrrd1/REDs/lindane_red.pdf aThis number is based on the es-timated amount used for lindane treated seed planted in the US. This amount includes pharmaceu-tical use (about one metric ton). bPublic health uses are for human lice and scabies uses only. No veterinary topical insecticides con-taining lindane are registered in the US

EU Yes D12/13: No longer rele-vant

D14/15: Yes

D16: No longer relevant D17: Yes

Unknown

* … country responded only in 2002 - … Answer self-evident from question D10

http://www.epa.gov/oppsrrd1/RED

page 21/38

Table I-3: Actions to control the production and use of lindane, part 4 of the questionnaire 2004 Question Country

D25: Is lin-dane cur-rently subject to any con-trol actions?

D26: What is the current registration status of lindane in your country?

D27: Short description of the national actions to control production and use?

D28: Are there any exemptions for the con-trol actions? D29: Short description of these exemptions


ARMENIA Yes Banned As the lindane is not included in the “List of plant protection chemical and biological substances allowed for use in Republic of Armenia” approved by the Minister of Agriculture decree (No198-N on November 18, 2003) its import and use is prohibited in Armenia.

No Lindane is not included in the “List of plant pro-tection chemical and biological substances allowed for use in Republic of Armenia” ap-proved by the Minister of Agriculture decree (No198-N on November 18, 2003); this means lindane import and use is banned in Armenia.

AUSTRIA Yes Limited authorisa-tion

Lindane (and/or HCH) is regulated by various national regulations: BGBl. 577/1990: Prohibition of produc-tion, placing on the market or use of antifoulings containing HCH BGBl. 97/1992: In the context of the food law: prohibition of HCH (CAS 608-73-1, 319-84-6, 319-85-7, 58-89-9, 319-86-8) used for stock protection and pest control. BGBl. 97/1992: Prohibition of HCH used as plant protection product. y-HCH can still be used as seed dressing in arable cropping. BGBl. 747/1995 idgF: Lays down the maximum acceptable residue levels of HCH and lindane in foodstuff. BGBl. II 375/1999: Use of lindane and HCH in cosmetic products is prohibited. BGBl. 448/1991 idgF: Lays down the maximum acceptable concentration in drinking water. BGBl. 292/2001: Regu-lations the occurrence and limits for lindane in compost.

No

BELGIUM No No longer author-ised

- -

page 22/38

Question Country






BULGARIA Yes Banned Lindane is banned with Order of the Minister of Agriculture and Forestry, Minister of Health and Minister of Envi-ronment and Water

-

CANADA Yes Authorised No longer author-ised

Agricultural use: Unless registered un-der the Canadian Pest Control Products Act, pesticides may not be imported, sold or used in Canada. Lindane is not registered for veterinary use as a topical treatment. After Dec 31, 2004, lindane will no longer be reg-istered for pest control product use in Canada.

No Human Health: The Canadian Food and Drug Act authorizes the use of lindane for human health applications. Pest Management Regulatory Agency (Health Canada), REV2002-02 “Update on the Special Review of Lindane and the Status of Lindane Registrations”, April 05, 2002. http://www.hc-sc.gc.ca/pmra-arla/english/pdf/rev/rev2002-02-e.pdf

CROATIA* Yes Banned Banned in 2001 CZECH RE-PUBLIC

Yes Banned Lindane is part of monitoring and con-trol programmes (air, waters, sedi-ments, soils, vegetation, feedstuff, food, total diet study, human exposure)

No National POPs Inventory Information from expert of Ministry of Agricul-ture of the Czech Republic Information from expert of Ministry of Health of the Czech Republic

CYPRUS Yes Banned Import is prohibited. Customs authori-ties have a list of all prohibited sub-stances, to prevent their import

No

DENMARK Yes Banned Chemical inspection check storage No FINLAND Yes Banned The use of lindane as pesticide was

restricted already in 1972 and banned in 1987. No wood preservatives con-taining lindane have been authorised during the present authorisation system (since 1989). Lindane containing prod-ucts have not been authorised as medi-cines or veterinary medicines, either.

No The present legislation does not ban all uses of lindane, and therefore it may, for example, be used in scientific research. The major use areas of lindane are, however, either covered by the ban or controlled by authorisation procedures.

FRANCE Limited authorised GEORGIA* Yes Banned

http://www.hc-sc.gc.ca/pmra

page 23/38

Question Country






GERMANY Yes Limited authorised

All uses in plant protection products are banned. Establishment of an authoriza-tion procedure for biocidal uses is being implemented.

No

EU chemical legislation is underway to adapt for ratification of i.a. UNECE protocol. In that context it is foreseen that any limited uses of lindane will cease by end of 2007.

IRELAND Yes Limited authorised Relevant pesticides control legislation (Tom O’Flaherty of PCS). Authorised for limited use by the Irish Medicines Board. See Section D, Part 2 comments.

Unknown

Tom O’Flaherty of PCS and Irish Medicines Board under the aegis of the Department of Health and Children.

ITALY Yes Limited authorised Banned

Commission Decision 2000/801/EC of 12/20/2000: non-inclusion of Lindane in Annex I of Council Directive plant-protection products containing this ac-tive substance, implemented in Italy 91/414/EEC and the withdrawal of au-thorisations by the Ministerial Order of 05/14/2001 (G.U. n.117 of 05/22/2001) (authorisation for production until 06/20/2001, authorisation for sale until 03/31/2002, authorisation for use until 05/31/2002).

Unknown

The national actions for the use of Lindane as biocide is under definition.

KAZAKHSTAN* Yes Banned LATVIA Yes Banned Import, sales and use of HCH (contain-

ing < 99 % gamma-HCH) is prohibited No Data base on chemical substances and chemi-

cal products (Latvian Environment Agency, 1995-2000). Regulations of the Cabinet of Ministers No.107 “Regulation Regarding Prohibited Plant Protec-tion Products” (21.03.2000).

LITHUANIA Yes Banned Lithuanian Hygienic Standard HN 63:2003 „Banned and restricted pesti-cides“

page 24/38

Question Country






MOLDOVA* Yes Banned - Lindane banned on 13.03.1991; - Lindane not included in the official register of permitted substances for use in agriculture, including and individual farms, forestry and household; Accord-ing Article 13 (5) of the Law on Plants Protection: “Is not allowed use of chemical and biological plants protec-tion products and plants growth regula-tors, prohibited for use in the Republic of Moldova in reason of ecological safety and presence of menace for health”; - Law on Regime of Harmful Products and Substances constitutes legal basis for activity related to production, stor-age, transportation and use of hazard-ous products and substances, their import and export aimed at reducing or eliminating their adverse impacts on human health and the environment. - There is Sanitary – hygienic Regula-tion on storage, use, neutralisation and disposal of toxic products, substances and wastes, which formulates concrete control actions, related the above-mentioned activities; -The National Programme on Produc-tion and Municipal Wastes Manage-ment was elaborated and published, which included some provisions con-cerning solution of the POPs pesticides. This Programme was approved by the Government’s Decision Nr. 606 from 28.06.2000 and published;

-The Plan of measures on Centralizing Storage and Disposal of Obsolete Unused and Prohib-ited Pesticides was elaborated and published. This Plan was approved 15 January 2001 (Government’s Decision Nr. 30 from “On Measures for Centralizing Storage and Disposal of Obsolete Unused and Prohibited Pesti-cides”); -According to the National Centre of Preventive Medicine data Lindane’s containing in environ-ment restricted by:

the maximum permissible concentration in air of the working zone (vapour and aero-sols) is 0,05 mg/m3. Unfortunately the maximum permissible concentration for Lindane in air of residential areas didn’t es-tablished yet; the indicative permissible level for water used potable purposes is 0,004 mg/l; - the maximum permissible quantity in soil

is 0,1 mg/kg; the allowable residual concentration in food: for potatoes is 0,05 mg/kg; for milk and milk prod-uct is 0,2 mg/kg; for apples, pears, vegetables (excepting carrot) is 0,5 mg/kg; for carrot, sugar beet, peas, eggs is 0,1 mg/kg; flesh of poultry is 0,7 mg/kg; for dry beans is 1 mg/kg.

page 25/38

Question Country






MONACO* No Other Use or lindane is forbidden in France since 1st July 1998. It is also forbidden to put this product on the market in this country. There is no regulation about lindane in Monaco. However, since France and Monaco form a customs union, there is no possibility to buy lindane in Monaco.

NETHER-LANDS

Yes Banned Lindane is banned in the Netherlands (Pesticide Act). Source: Ministry of Housing, Spatial Planning and the Environment: Emis-sion reduction targets for priority sub-stances. June 2001 (in Dutch).

No Board for the authorisation of pesticides in the Netherlands (CTB).

NORWAY Yes Banned The use of lindane was banned and the control action came into force 1.1.1994

No

POLAND Yes Banned The use, marketing and recycling of Lindane are prohibited in Poland.

No Source of information: Pesticide Registration Bureau Regulation of the Minister of Agriculture and Rural Development of 5 March 2002 on detailed rules for granting permits for marketing and use of plant protection products (Dz. U. 2002, No. 24, item 250) (Annex 9. Bio-active substances, contained in plant protection products, which are prohibited from use in Poland) Act of 27 April 2001 on Environmental Protec-tion Law (O.J. 2001, No. 62, item 627; as amended) with its executive acts (regulations) Regulation of the Minister of the Environment of 9 December 2003 on substances posing spe-cial environmental threats (Dz.U. 2003, No. 217, item 2141).

SLOVAKIA* Yes Banned No

page 26/38

Question Country






SPAIN* Yes No longer author-ised Banned

No more use as agricultural pesticide (Decision 2000/801/EC), Regulation (EEC) nº 2455/92 related to importa-tion-exportation (PIC), Decision EEC 2001/852/CE DOCE L of 4.12.2001.

No

SWEDEN Yes Banned Plant Protection Products containing Lindane are not allowed within EU after June 2002

Council Directive 91/414/EEC concerning the placing of plant protection products on the mar-ket. This Directive is implemented in Sweden through the Swedish National Chemicals In-spectorate Regulation 1998:8 concerning Chemical Products and Biotechnical organisms

SWITZER-LAND

Yes

Limited authorisation

According to the Ordinance relating to Environmentally Hazardous Sub-stances of 9 June 1986 (annex 3.1), the manufacture, supply, import and use of the hexachlorocyclohexane (HCH, all isomers) is prohibited.

No

Gamma-hexachlorocyclohexane (lindane) is allowed in seed dressings for agricultural pur-poses and in pharmaceutical products. There is a proposal to ban the use for seed dressings as it is no longer relevant.

TURKEY Yes Banned It was banned by Ministry of Agriculture

and Rural Affairs No -

UK Yes Limited authorised Other

Existing authorisations for some uses are being withdrawn

Unknown

USA Yes Limited authorised

The registrants for lindane have volun-tarily cancelled all pesticidal uses in the US except for seed treatment. Seed treatment is limited to 6 or 7 crops, specifically barley, corn, oats, rye, sor-ghum, wheat, and perhaps canola in the future. In the US, Lindane is avail-able by physician prescription for hu-man head lice and scabies. No other public health uses are allowed.

Yes USEPA, 2002. Office of Pesticide Programs, Lindane Re-registration Eligibility Decision. http://www.epa.gov/oppsrrd1/REDs/lindane_red.pdf USEPA, 2001 b. Personal communication be-tween Mark Howard, EPA/OPP and Janice Jensen, EPA/OPP, on December 19, 2001.

http://www.epa.gov/oppsrrd1/REDs/lindane_red

page 27/38

Question Country






EU Yes Limited authorised At the moment, production of HCH/ lindane has not been regulated in the Community. The marketing and use of HCH/lindane as a plant protection product has been prohibited by Com-mission Decision 2000/801/EC, whereas the other uses have not yet been regulated. The Commission has proposed a Regulation of the European Parliament and the Council on Persis-tent Organic Pollutants (COM(2003) 333 final), which contains restrictions of production, placing on the market and use of HCH/lindane. The Parliament has adopted a legislative resolution on the Regulation, and the Council and the Parliament are expected to adopt the Regulation in spring 2004. According to one of the amendments, the production, marketing and use of HCH/lindane shall be prohibited. By way of derogation, Member States may allow the use of HCH/lindane: Until 1 September 2006: professional remedial and industrial treatment of lumber, timber and logs, and indoor industrial and residential applications; Until 31 December 2007: Technical HCH for use as an intermedi-ate in chemical manufacturing; Products in which at least 99 % of the HCH isomer is in gamma form (lindane) are restricted for use as public health and veterinary topical insecticide.

Yes The forthcoming Regu-lation on POPs would allow the use of HCH/lindane for labora-tory scale research and as a reference stan-dard. In addition, prohi-bitions would not apply to a substance occur-ring as an unintentional trace contaminant in substances, prepara-tions and articles, or in the case of a substance occurring as a constitu-ent of articles produced or already in use before or on the date of entry into force of the Regu-lation.

Commission Decision 2000/801/EC concerning the non-inclusion of lindane in Annex I to Coun-cil Directive 91/414/EEC and the withdrawal of authorisations for plant-protection products containing this active substance, see: http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=EN&numdoc=32000D0801&model=guichett The Commission proposal COM(2003) 333 final for the POP Regulation is available at : http://europa.eu.int/eur-lex/en/com/pdf/2003/com2003_0333en01.pdf The EP legislative resolution amending the Commission proposal is available at: http://www2.europarl.eu.int/omk/sipade2?PUBREF=-//EP//TEXT+REPORT+A5-2004-0017+0+NOT+XML+V0//EN

* … country responded only in 2002

http://europa.eu.int/smartapi/cgi/sga_doc?smart

http://europa.eu.int/eur

http://www2.europarl.eu.int/omk/sipade2?PUBR

page 28/38

Annex IA: Additional information on alternatives Table IA: Available alternatives to the pesticidal uses39 of Lindane in Canada, the United States, and Mexico June 28, 2004

Lindane Use Site Pest Canadian Registered Alter-

natives US Registered Alterna-

tives Mexican Registered Alter-

natives Seed Treatments Canola flea beetle Acetamiprid, clothianidin, thia-

methoxam, imidacloprid clothianidin thiamethoxam imidacloprid

no information

Corn wireworm Clothianidin, imidacloprid (only for field corn grown for seed) tefluthrin

imidacloprid thiamethoxam permethrin tefluthrin clothianidin

acephate carbofuran diazinon malathion trichlorfon

Barley wireworm Thiamethoxam, imidacloprid no information Wheat wireworm Thiamethoxam, imidacloprid Carbofuran, malathion Oat wireworm no registered alternatives no information Rye

wireworm

No products registered. Thia-methoxam under review

no registered alternatives no information

Sorghum wireworm no registered alternatives Thiamethoxam, imidacloprid Carbofuran, diazinon, malathion Livestock Treatments

Beef Cattle

hornfly, lice, tick

carbaryl, coumaphos, diazinon, dichlorvos, fenthion, malathion, phosmet, tetrachlorvinphos, trichlorfon, cyfluthrin, cyperme-thrin, fenvalerate, permethrin, pyrethrin, rotenone Veterinary Drugs : eprinomectin, ivermectin, abamectin, doramec-tin, moxidectin

carbaryl, coumaphos, cyfluthrin, cypermethrin, diazinon, dichlor-vos, fenvalerate, lambda-cyhalothrin, malathion, perme-thrin, phosmet, pyrethrin, tetra-chlorvinfos, trichlorfon Veterinary Drugs : eprinomectin, ivermectin, doramectin, mox-idectin, methoprene

coumaphos, cyhalothrin, cyper-methrin, deltamethrin, diazinon, dichlorvos, fenthion, permethrin, tetrachlorvinfos, trichlorfon

39Table only includes uses of lindane registered in at least one of the three NAFTA countries, with the exception of canola. Canola is not registered in any of the three countries, but is being petitioned for use in the United States. Shaded blocks indicate that use is not registered in the corresponding country.

page 29/38

Lindane Use Site Pest Canadian Registered Alter-

natives US Registered Alterna-

tives Mexican Registered Alter-

natives Swine lice, mange

mite, flea carbaryl, malathion, phosmet, rotenone Veterinary Drugs: doramectin, ivermectin

amitraz, coumaphos, malathion, methoxychlor, phosmet perme-thrin, tetrachlorvinfos Veterinary Drugs: doramectin, ivermectin

tetrachlorvinfos (unclear whether products listed for use on “meat” include swine)

Ornamental Use Ornamen-tal Plants (foliar)

Several Numerous alternatives are avail-able

Numerous alternatives are available

Numerous alternatives are avail-able

page 30/38

Annex II: Result of the survey in UNECE region 2002 Table II-1: Information on the production and volume of lindane, part 1 of the questionnaire 2002

D2 D3 D4 D5 D6 D7 D8 D9 Question

Country

Is lindane presently pro-duced in your country?

In what quantity?

Was lindane ever produced in your

country?

Estimated years in which produc-tion took place?

Is lindane presently im-ported in your country?

In what quantity?

Is lindane cur-rently exported from your coun-

try?

In what quantity?

ARMENIA No No Unknown No

Austria No No Unknown No

Belgium No No No No

Canada No No Yes Unknown

CROATIA No No No No

CZECH. REP. No Yes 1985 No No

DENMARK No Unknown No

FRANCE No Yes

FINLAND No No No No

GEORGIA No No Unknown No

GERMANY No Yes Unknown Yes < 1 t/a No

ITALY No No Unknown No

KAZAKHSTAN No No Unknown No

LATVIA No No No Unknown

MOLDOVA No No No No

MONACO No Unknown No No

NETHER-LANDS

No Unknown No No

page 31/38

D2 D3 D4 D5 D6 D7 D8 D9 Question

Country

Is lindane presently pro-duced in your country?

In what quantity?

Was lindane ever produced in your

country?

Estimated years in which produc-tion took place?

Is lindane presently im-ported in your country?

In what quantity?

Is lindane cur-rently exported from your coun-

try?

In what quantity?

NORWAY No No No No

POLAND No Yes Until 1985 at a semi-technical

scale

No No

SLOVAKIA No No No No

SPAIN No Yes Not available Yes Not available

No

SWEDEN No No No No

SWITZER-LAND

No Unknown Yes No

UK Unknown Unknown Yes Unknown

US No Yes Estimated from 1950s - 1970s

Yes Approx. 90 metric tonnes/a

*

Yes ** 0-25 metric tonnes/a ***

* This number is based on the estimated amount of active ingredient used for lindane treated seed in the US. The amount used for public health purposes is not known (USEPA, 2001).

** Lindane is not currently manufactured in the US. The lindane active ingredient is imported into the US and formulated into pesticide products. Some of these pesticide products are exported (USEPA, 2002).

*** Until 2001, an estimated 500 metric tonnes of lindane that was included in pesticide products was exported. Beginning in 2001, the amount has dropped to approxi-mately 25 tonnes. We expect this amount to drop significantly because of further reduced use of lindane products in other countries (USEPA, 2002).

page 32/38

Table II-2: Information on the use of lindane: part 2 of the questionnaire 2002

D10 D11 D12 D13 D14 D15 D16 D17 D18 Question

Country

Current use What quantity? Seed treatment Incorporation in soil

Wood preservation

Public / animal health

Tree nurseries etc.

Indoor applica-tion

Other types

ARMENIA Unknown Unknown Unknown Unknown Unknown Unknown Unknown Unknown

Austria Unknown No No longer relevant

No longer relevant

Yes No longer relevant

No longer relevant

Unknown

Belgium No No longer relevant

No longer relevant

No longer relevant

No longer relevant

No longer relevant

No longer relevant

No

Canada app. 133 met-ric tonnes/a

No longer relevant

No longer relevant

No longer relevant

Unknown No longer relevant

No longer relevant

No

CROATIA Yes Estimates not available

No No No Yes No No No

Czech Re-public

No Unknown Unknown No longer relevant

No longer relevant


Unknown

Denmark No

FINLAND No

FRANCE Yes No longer relevant

No longer relevant

Yes Yes Yes Used in veter. medicine and other veter. products

GEORGIA No No longer relevant

No longer relevant

No longer relevant

No longer relevant

No longer relevant

No longer relevant

No

GERMANY Yes < 1 t/a No longer relevant

No longer relevant

No longer relevant


Yes Restricted to outdoor use for pest control on refuse pits (public health purposes)

ITALY Unknown No longer relevant

No longer relevant


Unknown Unknown Unknown

page 33/38

D10 D11 D12 D13 D14 D15 D16 D17 D18 Question

Country

Current use What quantity? Seed treatment Incorporation in soil

Wood preservation

Public / animal health

Tree nurseries etc.

Indoor applica-tion

Other types

LATVIA No Unknown Unknown Unknown Unknown Unknown Unknown Unknown

Kazakhstan No Unknown Unknown Unknown Unknown Unknown Unknown No

MOLDOVA No Unknown Unknown Unknown Unknown Unknown Unknown Unknown

MONACO No No longer relevant

No longer relevant

No longer relevant

No longer relevant

No longer relevant

No longer relevant

No

NETHER-LANDS

No No longer relevant

No longer relevant

No longer relevant

No longer relevant

No longer relevant

No longer relevant

No

NORWAY No No longer relevant

No longer relevant

No longer relevant

No longer relevant

No longer relevant

No longer relevant

No

POLAND No

SLOVAKIA No No longer relevant

No longer relevant

No longer relevant

No longer relevant

No longer relevant

No longer relevant

SPAIN Yes Not available No longer relevant

No longer relevant

No longer relevant

No longer relevant

No longer relevant

Yes No

SWEDEN No No longer relevant

No longer relevant

No longer relevant

No longer relevant

No longer relevant

No longer relevant

No

SWITZER-LAND

Yes < 1 t/a No longer relevant

No No Yes No No No

UK Yes Unknown Yes No longer relevant

Yes Yes Yes Yes Unknown

Yes Approx. 105 metric t/a *


No longer relevant

Yes ** No longer relevant

No longer relevant

No

US * This number is based on the estimated amount used for lindane treated seed planted in the US. The amount used for public health is less than 5 metric tonnes per year.

** Public health uses are for human lice and scabies only. No veterinary topical insecticides containing lindane are registered in the US.

page 34/38

Table II-3: Comments/Source of information, part 2: AUSTRIA Lindane was used as insecticide in more than 100 plant protection products against soil pests (e.g. wire-worms), weevils and

barks. Most of the products were phased out in the early 1990, although it was still used as seed dressing till 1997. The amounts of lindane used in agriculture dropped from 17 tonnes in 1992, 2.3 tonnes in 1997 to zero in 1998. Lindane is used for medical treatment in various products (source: Austria Codex 2000/2001). 2 products (Jacutin gel and Jacutin emulsion) are registered for the treatment of scabies in humans. Currently 4 veterinary products are registered in Austria.

GERMANY Generally the application of lindane containing wood preservation agents ceased by a voluntary initiative of industry. The last permitted wood preservation agent was taken from the market in 1990/1991. Use of Lindane/DDT containing products (Hylotox) for wood preservation used on the area of the former GDR ceased in 1989/1990. However, there is -up to now- no general obliga-tion for authorisation of wood preservatives in Germany. This causes an extensive “grey market” volume. It cannot be excluded that lindane-containing products are still imported/applied. The last authorisation of a lindane – containing pesticide for agricul-tural use ceased at the 31.12.1997 (use for control of wireworms (Agriotes spp.) - in maize and sugar beet.

Republic of MOLDOVA

Lindane banned on 13.03.1991; Lindane not included in the official register of permitted substances for use in agriculture, including and individual farms, forestry and household; at the same time in conformity with Ministry of Agriculture and Food Industry data: - use of Lindane in 1990 was 800 kg; use of Lindane in 1991 was 150 kg.

MONACO Use or lindane is forbidden in France since 1st July 1998. It is also forbidden to put this product on the market in this country. There is no regulation about lindane in Monaco. However, since France and Monaco form a customs union, there is no possibility to buy lindane in Monaco.

POLAND The use of HCH/lindane is not permitted in Poland. Source of information: Information from the former producer.

SPAIN Lindane is not introduced in annex I of the Directive 91/414/CE related to pesticides regulation (European legal framework: DOCE L 21-12-2000 Decision 2000/801/EC) The use of HCH isomers other than γ-HCH (Lindane) is banned in Spain (Orden Ministerial, BOE 17-02-1994).

US The USEPA is in the process of considering the re-registration of lindane. The preliminary risk assessments are published on the following website: http://www.epa.gov/pesticides/reregistration/lindane HCH was banned in 1978, gamma HCH severely restricted, sale limited to seed treatment and human lice and scabies control uses.

http://www.epa.gov/pesticides/reregistration/lindane

page 35/38

Table II-4: Regulatory actions Country Action Canada In Canada, plant protection products have to be authorised by the Pest Management Regulatory Agency according to

the Pest Control Products Act (PCPA). Under the PCPA, the sources of lindane have been restricted to those with mod-ern acceptable chemistry data and the registrants have voluntarily discontinued products for uses other than seed treatment. The renewal period of products has been truncated since 1998. Products were renewed for a one-year term during the special review of lindane. Currently Canada intends to phase out all use of lindane under the PCPA by De-cember 31, 2004. Public health uses are not subject to the PCPA.

US The registrants for lindane have voluntarily cancelled all pesticidal uses except for seed treatment. Seed treatment is limited for 6 to 7 crops. Lindane is also registered for public health uses.

European Union Lindane was part of the European Union’s review programme for pesticides according to Dir. 91/414/EC. Lindane was

not included in Annex I of the Directive, that means that after a period of grace lindane cannot be used as an active in-gredient of a plant protection product. During this period there are still some authorisations existent in single member states of the EU. Directive 98/8/EC will regulate the use of lindane as a biocide. Lindane (and/or HCH) is regulated by various national regulations: BGBl. 577/1990: Prohibition of production, placing on the market or use of antifoulings containing HCH

Austria

BGBl. 97/1992: Prohibition of HCH used as plant protection product. y-HCH can still be used as seed dressing in arable cropping. BGBl. 448/1991 idgF: Lays down the maximum acceptable concentration in drinking water. BGBl. 97/1992: In the context of the food law: prohibition of HCH (CAS 608-73-1, 319-84-6, 319-85-7, 58-89-9, 319-86-8) used for stock protection and pest control BGBl. 747/1995 idgF: Lays down the maximum acceptable residue levels of HCH and lindane in foodstuff. BGBl. II 375/1999: Use of lindane and HCH in cosmetic products is prohibited. BGBl. 292/2001: Regulations on the occurrence and limits for lindane in compost.

Belgium There are no current authorisations for lindane. Denmark Lindane is banned for all uses Finland The use of lindane as pesticide was restricted already in 1972 and banned in 1987. No wood preservatives containing

lindane have been authorised during the present authorisation system (since 1989). Lindane containing products have not been authorised as medicine or veterinary products.

Germany Lindane is not generally banned but phased out for specific applications (use as antifouling, application in mills, cereal stores and products from cereals, active ingredient in pesticide preparations).

Italy The national actions for the use of Lindane as biocide is under definition. Commission Decision 2000/801/EC of 12/20/2000: non-inclusion of Lindane in Annex I of Council Directive plant-protection products containing this active substance, implemented in Italy 91/414/EEC and the withdrawal of authorisa-tions by the Ministerial Order of 05/14/2001 (G.U. n.117 of 05/22/2001) (authorisation for production until 06/20/2001,

page 36/38

authorisation for sale until 03/31/2002, authorisation for use until 05/31/2002). France (and Monaco) Lindane is subject to limited authorisations for wood treatment, public health uses and indoor industrial and residential

uses. As Monaco forms a custom’s union with France the same regulations apply to this country. Netherlands Lindane is banned according to the Pesticides Act. Spain Exports of lindane are subject to Reg. 2455/92 on the export and import of dangerous substances. Sweden Dir. 91/414/EEC is implemented in Sweden through the Swedish National Chemicals Inspectorate Regulation 1998:8

concerning Chemicals Products and Biotechnical organisms. United Kingdom Authorisations fur agricultural uses are still existent but will be withdrawn till June 2002 in line with Decision

2000/801/EC. Armenia Lindane is banned. Czech Republic Lindane is banned. Kazakhstan Lindane is banned according to the Law of the Republic of Kazakhstan on Environmental Protection. Storage, transport

and deposition is regulated by the Instruction on State Control for Storage, Usage and Utilisation and Transportation of Plants Protection Means and the Instruction on the Procedure of Deposition or Destruction of Prohibited or Spoiled Pes-ticides and Container where they were kept.

Latvia Lindane is banned according to the Regulation Regarding Prohibited Plant Protection Products (Regulations of the Cabinet of Ministers No. 107; 21. 03.2000).

Republic of Moldova As of 13 March 1993 Lindane is banned and it is not included in the official register of permitted substances for use in agriculture, forestry and household. The Law on Regime of Harmful Products and Substances regulates storage and transportation. The National Programme on Production and Municipal Wastes Management, which includes some pro-visions concerning the POPs-pesticides, was approved by the Government’s decision Nr. 606 from 28. 06. 2000, and published. The Government’s decision from 15 January 2001 “On Measures for Centralising Storage and Disposal of Obsolete Unused and Prohibited Pesticides” focuses on the management of obsolete and prohibited pesticides. Accord-ing to the National Centre of Preventive Medicine al lot of limit values for lindane exist (e.g. in food stuff, water, soil and air).

Norway The use of lindane was banned and the control action came into force by 1 January 1994. Poland According to the Pesticide Registration Bureau lindane is banned and not permitted to be put on the market. Slovakia All uses of lindane are banned. Switzerland According to the Ordinance relating to Environmentally Hazardous Substances of 9 June 1986 (annex 3.1), the manu-

facture, supply, import and use of hexachlorocyclohexane (HCH, all isomers) is prohibited. The use of lindane for seed dressings and in pharmaceutical products is allowed. There is a proposal to ban the use for seed dressings, as it is no longer relevant.

page XXXVII/38

Annex III: Status of responding parties under the POP Protocol by February 2004

Country Sig-nat..

Ratif.. Resp.1st Resp. 2nd

Armenia X X X Austria X X X X Belgium X X X Bulgaria X X X Canada X X X X Croatia X X Cyprus X X Czech Rep.

X X X X

Denmark X X X X Finland X X X X France X X X X Georgia X Germany X X X X Greece X Hungary X X Iceland X X Ireland X X Italy X X x Ka-zakhstan

X

Latvia X X X Liechten-stein

X X

Lithuania X X Luxem-bourg

X X

Monaco X Moldova X X X

Country Signat.. Ratif.. Resp.1st Resp. 2nd

Netherlands X X X X Norway X X X X Poland X X X Portugal X Romania X X Slovakia X X X Slovenia X Spain X X Sweden X X X X Switzerland X X X X Turkey X Ukraine X UK X X X USA X X X European Commu-nity

X X

Total: 36 19 25 24 Signat = signature to Protocol Resp 1st = responder to survey 2001 Ratif. = ratification of Protocol Resp 2nd = responder to survey 2004

page 38/38

Date post:	15-Jul-2020
Category:	Documents
Upload:	others
View:	1 times
Download:	0 times

Report Lindane 0804...HCH a cumulative use of 259 000 tonnes α-HCH, 20 000 tonnes β-HCH, and 135...

Documents