Substitution methodologies:

1. Substitution methodologies: WHY and HOW do governments and industry implement safer substitutes

2. Some Governments in the forefront of substitution: Sweden � Chemical Products Act 1990 Denmark � Precautionary Principle Norway � Nordic substitution Germany-Gefahrstoffverordnung (GefStV = German decree on dangerous substances) UK � recent Royal Commission on Environmental Pollution EU - Integrated Pollution Prevention and Control Directive, biocides�.REACH to some extent Paragraph 16 of the Gefahrstoffverordnung (GefStV = German decree on dangerous substances) already currently obliges employers to carry out risk assessments at workplaces and to find alternative substances when the health of their employees is at risk. Environmental risks are to be taken into account in the search for alternative substances. Paragraph 16 of the Gefahrstoffverordnung (GefStV = German decree on dangerous substances) already currently obliges employers to carry out risk assessments at workplaces and to find alternative substances when the health of their employees is at risk. Environmental risks are to be taken into account in the search for alternative substances.

3. Sweden�s new chemical policy "The environment must be free from man-made substances and metals that represent a threat to health or biological diversity" GOAL Within ONE GENERATION: The concentrations of substances that naturally occur in the environment are close to the background concentrations. The levels of foreign substances in the environment are close to zero. Overall exposure in the work environment, the external environment and the indoor environment to particularly dangerous substances is close to zero and, as regards other chemical substances, to levels that are not harmful to human health. Polluted areas have been investigated and cleaned up where necessary. 

4. Current targets in Sweden (1) Closing the Gap in knowledge about chemicals: - By 2010 data will be available for all manufactured products or extracted chemical substances put on the market- By 2010 all finished products will carry health and environmental information on dangerous substances

5. Current targets in Sweden (2) Phasing out particularly dangerous substances Newly manufactured finished products are to be free from:  Carcinogenic, mutagenic and reproductive substances by 2007 if the products are intended to be used in a way that will released their materials to the eco cycle All persistent and bioaccumulative substances will be banned by 2015 Mercury phased out by 2003; cadmium and lead by 2010

6. Current targets in Sweden (3) Risk reduction Tracking of negative health and environmental effects will be undertaken to ensure they are continuously being decreased up to 2010. Also substances that cannot be safely recycled will be continuously decreased. (NOTE: BFRs in plastics!)

7. Current Targets in Sweden (4) Remediation All polluted areas are identified and investigated. By 2010 measures will be taken for at least 30 per cent of any areas assigned as high risk. See www.kemi.se

8. Comparative Risk Assessment � Substitution How will it work? Vibeke Bernson National Chemicals Inspectorate, SWEDEN Presented Jan 9, 2003

9. The Swedish Environmental Code Chapter 2: sec 6: General Provision that should be used when examining approvals or permits and by everyone handling chemicals: Persons and enterprises shall avoid using or selling chemical products that may pose risks to human health or the environment if products that are less dangerous can be used instead.

10. Comparative Assessment/Substitution Is often used in its simplest form in every day life Is used in occupational health in UK since decades (7 steps to a successful substitution of hazardous substances) Is in use when approving pesticides in Sweden and has been used in Denmark All uses involve risks. However, we can overlook a majority of the risks because we find them acceptable in view of the benefits we gain from using pesticides. The risk/benefit approach is dynamic and will change over time depending on the need for plant protection and available alternatives.All uses involve risks. However, we can overlook a majority of the risks because we find them acceptable in view of the benefits we gain from using pesticides. The risk/benefit approach is dynamic and will change over time depending on the need for plant protection and available alternatives.

11. Prerequisite for a substitute present significantly less risk to human health or the environment, be sufficiently efficacious, be without unreasonable economic or practical disadvantages for the user. There are three major conditions to be fulfilled. Significantly less risk If the use area and mode of application are identical between the substances being compared, the exposure conditions can normally be assumed to be the same. This means that regulators essentially can rank the risk based on the intrinsic properties of the substances. This means for instance that you can�t compare risks for allergic reactions with risks for bird poisoning contamination. Comparative assessment mustn�t necessarily lead to rejection of the whole product. Be sufficiently effective This means in practice that it is desirable to have a number of active substances on the market with different modes of action. Some substances are considered to be indispensable. In such cases there might be a need to develop phase out plans. These plans must target on a very restricted use for a specified time period, long enough for the agriculture and the industry to adapt to the situation and to develop alternatives. It is often desirable to have both the substitute and the product to be substituted on the market at the same time to gain practical experience. Unreasonable economic or practical disadvantages However, these questions can not easily be answered. Once again it is advisable to await practical experience. There are examples where substitution were not possible to carry out as a result of practical disadvantages appearing during the use of the substitute.There are three major conditions to be fulfilled. Significantly less risk If the use area and mode of application are identical between the substances being compared, the exposure conditions can normally be assumed to be the same. This means that regulators essentially can rank the risk based on the intrinsic properties of the substances. This means for instance that you can�t compare risks for allergic reactions with risks for bird poisoning contamination. Comparative assessment mustn�t necessarily lead to rejection of the whole product. Be sufficiently effective This means in practice that it is desirable to have a number of active substances on the market with different modes of action. Some substances are considered to be indispensable. In such cases there might be a need to develop phase out plans. These plans must target on a very restricted use for a specified time period, long enough for the agriculture and the industry to adapt to the situation and to develop alternatives. It is often desirable to have both the substitute and the product to be substituted on the market at the same time to gain practical experience. Unreasonable economic or practical disadvantages However, these questions can not easily be answered. Once again it is advisable to await practical experience. There are examples where substitution were not possible to carry out as a result of practical disadvantages appearing during the use of the substitute.

12. No Substitution When the above prerequisites are not fulfilled. When the alternatives are too few and there is risk for resistance. When it is not possible to differentiate which product is the most risky. E.g. One product is of high concern for the environment and the other for health. When alternatives are not tested for efficacy in real conditions.

13. 7 steps to substitution Step 1: Products of concern Step 2: Alternatives � chemical or other Step 3: Properties of alternatives Step 4: Feasibility Step 5: Substitution at what level Step 6: Decision Step 7: Monitor and assess the change

14. Step 1 Product (use areas) of concern Decide whether the substance is still of concern: Is there a significant risk involved in storing, using or disposing of a substance Does it give hazardous residues in food and feed The difference in risks between products have to be significant to justify a refusal on the grounds of substitution If it is not possible to decide which products poses the least risk then substitution cannot be used

15. Step 2Alternatives � chemical or other Identify alternatives to all or some of the more risky use-areas. Are there more than one alternative? If not the possibility to substitute will be reduced.

16. Step 3Properties of alternatives Are there too few alternatives on the market so development of resistance could be anticipated. Are the alternatives sufficiently efficacious. Does the alternative cover all the uses or only some (partial substitution)

17. Step 4Feasibility Are the alternatives economically and practically feasible Are the alternatives proven applicable in the use situation discussed.

18. Step 5Comparative assessment - at which level? Comparative assessment should be tried at active ingredient level, at product approval level, advisor (extension service) level or at the farmer level. Could all or only some of the most risky use-areas be substituted?

19. Step 6Deciding � substituting ? Use-areas of high concern for which good alternatives are available should be substituted if the comparative assessment shows that it is feasible. Since only the same use can be substituted the exposure is usually the same and assessment can therefore be reduced to the hazard properties.

20. Step 7Monitor and assess the change Different monitoring depending on the situation and level at which substitution was done. E.g. monitor resistance

21. Comparative assessment in the decision-making process

22. Seven examples A group of chemically related substances Two different active substances A chemical versus a non-chemical method Substitution on parts of the use area Different formulations Step-wise approach in phase out plans Reconsideration after practical use of the substitute Seven examples These have been chosen to represent different categories of substitution. They are based on authentic cases, but some of them have been slightly modified to become more comprehensive. � 1.�� Pyrethroids, sulfonylureas etc. For instance if one of them differs significantly from the others. 2.��� This is perhaps the case that most of us have in mind when we think of substitution. 3.��� Not very common. It can sometimes lead to very complex assessment if, for instance the environmental impact due to the energy consumption and energy quality is also taken into account. 4.��� Parts of the use area. 5.��� Often very easy cases, so called re-formulation. I think also easy for industry to accept. 6.��� A step-wise approach on substitution can be very useful in phase out plans. 7.��� Substitution can off course be unsuccessful. It is therefore advisable to postpone the withdrawal and await practical experience.Seven examples These have been chosen to represent different categories of substitution. They are based on authentic cases, but some of them have been slightly modified to become more comprehensive. � 1.�� Pyrethroids, sulfonylureas etc. For instance if one of them differs significantly from the others. 2.��� This is perhaps the case that most of us have in mind when we think of substitution. 3.��� Not very common. It can sometimes lead to very complex assessment if, for instance the environmental impact due to the energy consumption and energy quality is also taken into account. 4.��� Parts of the use area. 5.��� Often very easy cases, so called re-formulation. I think also easy for industry to accept. 6.��� A step-wise approach on substitution can be very useful in phase out plans. 7.��� Substitution can off course be unsuccessful. It is therefore advisable to postpone the withdrawal and await practical experience.

23. Substitution of different formulations In a review of existing herbicides it is concluded that four out of a total of six sugar-beet herbicides containing the same active substance are based on an organic solvent D. The remaining two are instead based on an oil-miscible flowable concentrate (OF) containing vegetable oil. Solvent D is known to be a severe irritant to the skin, eyes, nose, and throat of exposed workers. The OF formulations show significantly better properties with regard to worker health, but are identical with regard to efficacy compared with the solvent D based formulations. In a review of existing herbicides it is concluded that four out of a total of six sugar-beet herbicides containing the same active substance are based on an organic solvent D. The remaining two are instead based on an oil-miscible flowable concentrate (OF) containing vegetable oil. Solvent D is known to be a severe irritant to the skin, eyes, nose, and throat of exposed workers. The OF formulations show significantly better properties with regard to worker health, but are identical with regard to efficacy compared with the solvent D based formulations.

24. Substitution of different formulations � Decision: Re-approvals of the four solvent D based products are rejected. Re-approvals are only granted for the two OF formulations. �� Decision: Re-approvals of the four solvent D based products are rejected. Re-approvals are only granted for the two OF formulations. �

25. A group of chemically related substances There is an application for approval of a selective herbicide intended to be used for pre- and post-emergence weed control in spring and winter cereals. The product contains an active substance A, belonging to a group of chemically related substances included in herbicide products approved for use in cereals. The four substances in question have similar properties with regard to weed control, thus being replaceable with each other. However, assessment of the environmental properties of the substances also taking into account the main metabolites revealed that substance A differs significantly from the others, since it is considered to be far more mobile and degraded more slowly in soil. Substance A is in contrary to the other substances, associated with risk for ground water contamination. There is an application for approval of a selective herbicide intended to be used for pre- and post-emergence weed control in spring and winter cereals. The product contains an active substance A, belonging to a group of chemically related substances included in herbicide products approved for use in cereals. The four substances in question have similar properties with regard to weed control, thus being replaceable with each other. However, assessment of the environmental properties of the substances also taking into account the main metabolites revealed that substance A differs significantly from the others, since it is considered to be far more mobile and degraded more slowly in soil. Substance A is in contrary to the other substances, associated with risk for ground water contamination.

26. A group of chemically related substances There is an application for approval of a selective herbicide intended to be used for pre- and post-emergence weed control in spring and winter cereals. The product contains an active substance A, belonging to a group of chemically related substances included in herbicide products approved for use in cereals. The four substances in question have similar properties with regard to weed control, thus being replaceable with each other. However, assessment of the environmental properties of the substances also taking into account the main metabolites revealed that substance A differs significantly from the others, since it is considered to be far more mobile and degraded more slowly in soil. Substance A is in contrary to the other substances, associated with risk for ground water contamination. There is an application for approval of a selective herbicide intended to be used for pre- and post-emergence weed control in spring and winter cereals. The product contains an active substance A, belonging to a group of chemically related substances included in herbicide products approved for use in cereals. The four substances in question have similar properties with regard to weed control, thus being replaceable with each other. However, assessment of the environmental properties of the substances also taking into account the main metabolites revealed that substance A differs significantly from the others, since it is considered to be far more mobile and degraded more slowly in soil. Substance A is in contrary to the other substances, associated with risk for ground water contamination.

27. Biocide directive 98/8 A biocide chemical may be refused or removed If the evaluation of the active substance �shows that under normal conditions�. risks to health or the environment still give rise to concern and If there is another active substance for the same produce type which present significantly less risks to health or to the environment.

28. Using non chemical alternatives: example: soil disinfectant Chemical Hazard confirmed by monitoring: groundwater contamination, carcinogenic, high mobility Alternatives assessed in the field: crop rotation, use of resistant crop varieties and avoiding cultivation of susceptible crops in infected areas. Short term cost to farmers weighed against beneficial influence on control of other plant diseases and long term strategy for sustainable agriculture Decision: Re-approval of the soil disinfectant is rejected by authorities. For control of potato cyst nematodes. Active substance shows high mobility; long-term studies indicate carcinogenic properties; associated with risk of ground water pollution, which has been confirmed in monitoring studies. Progress in regional advisory programmes shown feasibility of other plant protection practices such as crop rotation, use of resistant crop varieties and by avoiding cultivation of susceptible crops in infected areas. Can on a short term involve economic or practical disadvantages for the farmers. But crop rotation also has beneficial influence on the control of other plant diseases and is on a long term a strategy in line with sustainable agriculture. Unreasonable economic or practical disadvantagesWhen considering unreasonable economic and/or practical problems for users to use products with other active substances or to use non�chemical methods, the magnitude of what is unreasonable should be compared with the possible gain for the environment and/or for human health. This means that big advantages with regard to risks are allowed to cost more.However, there is no easy answer to whether substitution can lead to economic disadvantages or not for farmers, since this depends on several circumstances at the time of decision. One important circumstance is whether a monopolistic position (only one manufacturer involved) can arise, leading to increased product prices. For control of potato cyst nematodes. Active substance shows high mobility; long-term studies indicate carcinogenic properties; associated with risk of ground water pollution, which has been confirmed in monitoring studies. Progress in regional advisory programmes shown feasibility of other plant protection practices such as crop rotation, use of resistant crop varieties and by avoiding cultivation of susceptible crops in infected areas. Can on a short term involve economic or practical disadvantages for the farmers. But crop rotation also has beneficial influence on the control of other plant diseases and is on a long term a strategy in line with sustainable agriculture. Unreasonable economic or practical disadvantagesWhen considering unreasonable economic and/or practical problems for users to use products with other active substances or to use non�chemical methods, the magnitude of what is unreasonable should be compared with the possible gain for the environment and/or for human health. This means that big advantages with regard to risks are allowed to cost more.However, there is no easy answer to whether substitution can lead to economic disadvantages or not for farmers, since this depends on several circumstances at the time of decision. One important circumstance is whether a monopolistic position (only one manufacturer involved) can arise, leading to increased product prices.

29. Step-wise approach in phase out plans - the EBDC example Main concerns: Adverse effects in long term studies Repeated exposure for operators Probable leakage of the mobile metabolite ETU to groundwater

30. Step-wise approach in phase out plans - the EBDC example Restrictions: Only in potatoes and onions Only in mixed formulations Pre-harvest interval of 30 days Re-entry interval in the field of three days Out of all approved uses, substitution was not possible in potatoes and onions, so these two uses remained. Out of the eight products containing EBDC, five were mono-component formulations and the other three were mixed formulations containing EBDC in combination with other substances having other modes of action. The use of the mixed formulations involves considerable lower amounts of EBDC applied per treatment. But perhaps more important, also the No of application was possible to reduce due to longer treatment intervals with the mixed formulations. This was considered particular important, since it reduces the number of exposure occasions for farmers. There are also indications saying that the use of mixed formulations (mixture between contact and systemic fungicides) is the best chemical strategy available for control of the new mating type of Phytophthora infestans. Possibilities for a continued efficient control of late blight are therefore not considered to be affected, if only mixed formulations containing EBDC are approved. The applications for re-approval of the five mono-component formulations were withdrawn. Re-approvals for a limited period were only granted for the three mixed formulations in line with the ongoing phase out plan. Out of all approved uses, substitution was not possible in potatoes and onions, so these two uses remained. Out of the eight products containing EBDC, five were mono-component formulations and the other three were mixed formulations containing EBDC in combination with other substances having other modes of action. The use of the mixed formulations involves considerable lower amounts of EBDC applied per treatment. But perhaps more important, also the No of application was possible to reduce due to longer treatment intervals with the mixed formulations. This was considered particular important, since it reduces the number of exposure occasions for farmers. There are also indications saying that the use of mixed formulations (mixture between contact and systemic fungicides) is the best chemical strategy available for control of the new mating type of Phytophthora infestans. Possibilities for a continued efficient control of late blight are therefore not considered to be affected, if only mixed formulations containing EBDC are approved. The applications for re-approval of the five mono-component formulations were withdrawn. Re-approvals for a limited period were only granted for the three mixed formulations in line with the ongoing phase out plan.

31. Sold quantities of potato late blight products in Sweden Diagrammet redovisar f�rs�lda m�ngder av mankozeb (gr� del av stapeln) och alternativa bladm�gelmedel (vit del av stapeln). Det pekar p� en gynnsam utveckling och beroende p� den EU-gemensamma pr�vningen av mankozeb finns m�jlighet till en total utfasning. Flera nya verksamma �mnen �r p�g�ng som kan ers�tta mankozeb. To summarise the step-wise approach; 1st step � substitution of parts of the use area, 2nd step � mono-component formulations were substituted, 3rd step � the remaining EBDC products to be substituted. Diagrammet redovisar f�rs�lda m�ngder av mankozeb (gr� del av stapeln) och alternativa bladm�gelmedel (vit del av stapeln). Det pekar p� en gynnsam utveckling och beroende p� den EU-gemensamma pr�vningen av mankozeb finns m�jlighet till en total utfasning. Flera nya verksamma �mnen �r p�g�ng som kan ers�tta mankozeb. To summarise the step-wise approach; 1st step � substitution of parts of the use area, 2nd step � mono-component formulations were substituted, 3rd step � the remaining EBDC products to be substituted.

32. Is the substitute feasible? Example: New fungicide intended for cereals shows less persistence and bioaccumulation. However new substance is a severe irritant and only a gel formulation in water soluble plastic bags considered acceptable Use is monitored and found to have some technical problems Decision: The application for renewal of the existing chemical is not rejected. The new gel formulation is voluntary withdrawn by the registration holder. There is an application for approval of a fungicide product intended for use in cereals. The product contains an active substance F, which is chemically related to another substance already approved for the same use. Substance F show significantly better environmental properties compared to the existing substance, particularly regarding persistence and bioaccumulation. However, since the new substance is a severe irritant, only a gel formulation in water-soluble plastic bags is considered to be acceptable. The comparative assessment leads to an approval of the gel formulation of substance F, with the intention to substitute the existing chemically related substance at its next periodical review. The gel formulation of substance F has shown to be sufficiently effective in earlier trials, but after being used in practice some technical problems become apparent. Decision: The application for renewal of the existing chemically related substance is not rejected. The gel formulation of substance F is voluntary withdrawn by the registration holder.There is an application for approval of a fungicide product intended for use in cereals. The product contains an active substance F, which is chemically related to another substance already approved for the same use. Substance F show significantly better environmental properties compared to the existing substance, particularly regarding persistence and bioaccumulation. However, since the new substance is a severe irritant, only a gel formulation in water-soluble plastic bags is considered to be acceptable. The comparative assessment leads to an approval of the gel formulation of substance F, with the intention to substitute the existing chemically related substance at its next periodical review. The gel formulation of substance F has shown to be sufficiently effective in earlier trials, but after being used in practice some technical problems become apparent. Decision: The application for renewal of the existing chemically related substance is not rejected. The gel formulation of substance F is voluntary withdrawn by the registration holder.

33. In ConclusionsPractising substitution and comparative assessment Is most effective at the level of approval of products Shows that it is easier to rank and compare than to quantify potential risks Will act as a market force by promoting development and use of less risky pesticides Allows phase out period for industry to adapt and allow more data collection on substitute Comparative assessments are favoured by a procedure in which examination of all substances/products with similar use patterns occurs at the same time. This approach has been shown to be very cost-effective, since it promotes a uniform and efficient evaluation and decision making process. If identical exposure conditions exists, comparative assessment can in principle be based on the intrinsic properties of the substances. This approach serves regulators with an effective tool in risk reduction, since it is generally easier to compare and rank than to quantify potential risks. There are many examples in practice on how manufacturers/applicants with more favourable alternatives from a risk perspective have been encouraged to establish themselves on the market or increase their market shares as a result of regulatory action based on comparative assessments. Comparative assessments are favoured by a procedure in which examination of all substances/products with similar use patterns occurs at the same time. This approach has been shown to be very cost-effective, since it promotes a uniform and efficient evaluation and decision making process. If identical exposure conditions exists, comparative assessment can in principle be based on the intrinsic properties of the substances. This approach serves regulators with an effective tool in risk reduction, since it is generally easier to compare and rank than to quantify potential risks. There are many examples in practice on how manufacturers/applicants with more favourable alternatives from a risk perspective have been encouraged to establish themselves on the market or increase their market shares as a result of regulatory action based on comparative assessments.

34. In Conclusions Practising substitution and comparative assessment Comparative assessment and substitution are dynamic elements in the authorisation system that speeds up development towards safer products Will promote manufacturer that have low risk products. Need to also known when substitution cannot be practised (yet) Comparative assessments are favoured by a procedure in which examination of all substances/products with similar use patterns occurs at the same time. This approach has been shown to be very cost-effective, since it promotes a uniform and efficient evaluation and decision making process. If identical exposure conditions exists, comparative assessment can in principle be based on the intrinsic properties of the substances. This approach serves regulators with an effective tool in risk reduction, since it is generally easier to compare and rank than to quantify potential risks. There are many examples in practice on how manufacturers/applicants with more favourable alternatives from a risk perspective have been encouraged to establish themselves on the market or increase their market shares as a result of regulatory action based on comparative assessments. Experience from the Swedish Pesticide Approval System will be given on the use of substitution or comparative assessment. We have tried substitution in our reregistration program (we reregister the same product types together, e.g. fungicides, insecticides ..) and found that we could go forward and do a deeper comparative assessment on 10-15% of the products. For the rest it was early on obvious either that the difference in risk was too small to differentiate between, or one product had health risks and the others had environmental risks, which cannot be compared, or there were no acceptable alternatives. It is important to understand also when substitution cannot be used.Comparative assessments are favoured by a procedure in which examination of all substances/products with similar use patterns occurs at the same time. This approach has been shown to be very cost-effective, since it promotes a uniform and efficient evaluation and decision making process. If identical exposure conditions exists, comparative assessment can in principle be based on the intrinsic properties of the substances. This approach serves regulators with an effective tool in risk reduction, since it is generally easier to compare and rank than to quantify potential risks. There are many examples in practice on how manufacturers/applicants with more favourable alternatives from a risk perspective have been encouraged to establish themselves on the market or increase their market shares as a result of regulatory action based on comparative assessments. Experience from the Swedish Pesticide Approval System will be given on the use of substitution or comparative assessment. We have tried substitution in our reregistration program (we reregister the same product types together, e.g. fungicides, insecticides ..) and found that we could go forward and do a deeper comparative assessment on 10-15% of the products. For the rest it was early on obvious either that the difference in risk was too small to differentiate between, or one product had health risks and the others had environmental risks, which cannot be compared, or there were no acceptable alternatives. It is important to understand also when substitution cannot be used.

35. Germany and substitution Production of PBBs and PBDEs was stopped voluntarily in Germany as far back as 1986. German Universities and research supply technical expertise for international companies on alternatives assessment (eg Fujitsu, IKEA)

36. "Substituting Environmentally Relevant Flame Retardants: Assessment Fundamentals� Berlin 2001 UBA.

37. More pressure on PVC �The UBA has examined patterns of exposure to bisphenol A more closely in interviews with industry members, finding that key areas are use in thermopaper and as antioxidant or oxidation inhibitor in PVC. The voluntary agreement announced by the European PVC industry in March 2000 contains no commitments on bisphenol A.�

38. Guidance for the use of more environmentally sound substances Oekopol, Feb 2003 Substitution of PBT*- substancesin products and processes persistent, bioaccumulative, toxic For producers and professional users of chemical products with regard to /as relevant to the aquatic environment

39. Oekopol, 2003

40. Oekopol: risk factors

41. Oekopol research report on substitution 2003

44. Oekopol2003

45. Effect of German legislation: Siemens Norms on product design bans PBB and PBDE from all products and is researching remaining uses of other BFRs. BMW has banned PBB and PBDE from all their products. VW and Mercedes substituted halogen free materials for car seats and textile cover in 1996 and their current initiative is halogen free cables for their vehicles

46. Catalyst for BFR substitution Sony: �In response to the German dioxin ordinance of 1994, Sony Europe started investigating safer substitutes for halogen-based flame retardants. These include phenyl compounds containing bromine that release dibenzo-p-dioxin when they are subjected to high temperatures and/or are incinerated. Sony recognizes that �dioxin is the about 1000 times as toxic as cyanide and is said to be the most toxic carcinogen.� �Sony has developed halogen free circuit boards used in European television sets, VCRs and DVD players. Sony is using nitrogen/phosphorus based flame retardants that meet the most stringent global fire standards, which are set in the United States.�

47. WEEE has been a big driver for substitution Produer Responsibility for Waste from Electronic and Electrical Equipment (EU:2003)

48. INTEL and BFR-free Drivers �BFR-free is driven by many factors Internal EHS policies Legislation and Regulations Environmental Data Market and Perception Customer Supplier All three drivers must be balanced when developing a BFR-free position.�

49. BFR Position �Intel does not use PBB or PBDE in its products and works with its suppliers to ensure that these compounds are not used in the raw materials supplied to Intel. Intel has phased out the use of TBBPA other halogenated flame retardants in select server products and will continue to work with its suppliers to evaluate alternative flame retardants that meet its technical, environmental, and safety specifications.� TBBPA and other brominated flame retardants from plastic parts used in our server products.� All of our plastic enclosures and bezels on our servers are halogen-free.� some of the internal parts still contain halogens. TBBPA and other brominated flame retardants from plastic parts used in our server products.� All of our plastic enclosures and bezels on our servers are halogen-free.� some of the internal parts still contain halogens.

50. Summary (by Intel) There are many drivers to BFR-free Market pressure is the dominant factor Direction remains unclear BFR-free materials are available today in niche applications Many unknowns remain, particularly related to environment, but also technical Few options are available, and we cannot eliminate them without thorough studies Industry is looking for the best global solution A coordinated effort will save time, save money and benefit the environment.

51. Transparency along product chain major driver for substitution Product labeling still minimal BUT Producer Responsibility legislation is increasing component/parts labeling Some companies using web more Lists Environmental Product Declarations Supply Chain Management major issue in industry circles

52. largest producer of powered appliances for kitchen, cleaning and outdoor Company uses Environmental Product Declarations (EPD) on most individual product lines eg plastics do not contain cadmium, lead, mercury or their compounds or chlorinated or brominated flame retardants; metals are not coated with cadmium, chromium, or nickel; and metal paints do not contain pigments and additives based on heavy metals.�

53. Some companies list detailed chemical policy on website: eg. Volvo�s Black list (banned) Table 1E Group Substance name CAS no. 1) Example of type or areaof use Risk 2) Amines Phenyl-b-naphthylamine 135-88-6 Antioxidant C Methylenedianiline (4,4�-) 101-77-9 Hardener, in paints C CFC compounds CFC 11 75-69-4 Cooling agent, �freon� O CFC 113 76-13-1 Cooling agent, �freon� O CFC 114 76-14-2 Cooling agent, �freon� O CFC 115 76-15-3 Cooling agent, �freon� O CFC 12 75-71-8 Cooling agent, �freon� O Fibres Asbestos Several Insulating material C Flame retardants Polybrominated biphenyls Several PBBs, in plastics, textile E, N, C Polybrominated diphenyl ethers Several PBDEs, plastics, textile E Rubber chemicals Aminobiphenyl (4-) + salts 92-67-1 Dye C Benzidine (+ salts) 92-87-5 Dye C Thiocarbamide 62-56-6 Rubbers and plastics A, C Halons Halon 1211 353-59-3 Fire retardant O Halon 1301 75-63-8 Fire retardant O Halon 2402 124-73-2 Fire retardant O Chlorinated hydro- HCFC 3) Several Blowing agent, solvent Ocarbons PCB 1336-36-3 Insulators, oils, etc. E Hexachlorobutadiene 87-68-3 Solvent E, TCarbon tetrachloride 56-23-5 Solvent O, C, T Methylene chloride 75-09-2 Solvent, in fuel C 1, 1, 1-Trichloroethane 71-55-6 Solvent O Tetrachloroethylene 127-18-4 Solvent C Metals Lead chromate 7758-97-6 Pigment C, A, E, N Cadmium + Cd compounds 4) Several Pigment C, E Mercury + Hg compounds Several Electric equipment N, E Lubricants Chlorinated paraffins Several Oils, fire retardants E Mineral oil with PAHs 5) Several Base oils, lubricants, etc. C Surface-active agents 4-Nonylphenol Several Used as ethoxylates E Nonylphenolethoxylates Several Cleaning agent E Octylphenol Several Used as ethoxylates E Octylphenolethoxylates Several Cleaning agent E carbons PCB 1336-36-3 Insulators, oils, etc. E Hexachlorobutadiene 87-68-3 Solvent E, T Carbon tetrachloride 56-23-5 Solvent O, C, T Methylene chloride 75-09-2 Solvent, in fuel C 1, 1, 1-Trichloroethane 71-55-6 Solvent O Tetrachloroethylene 127-18-4 Solvent C Metals Lead chromate 7758-97-6 Pigment C, A, E, N Cadmium + Cd compounds 4) Several Pigment C, E Mercury + Hg compounds Several Electric equipment N, E Lubricants Chlorinated paraffins Several Oils, fire retardants E Mineral oil with PAHs 5) Several Base oils, lubricants, etc. C Surface-active agents 4-Nonylphenol Several Used as ethoxylates E Nonylphenolethoxylates Several Cleaning agent E Octylphenol Several Used as ethoxylates E Octylphenolethoxylates Several Cleaning agent E

54. Skanska Financial Times ranked Skanska as the world�s most respected company in the property and construction sector. Skanska was listed first on the Fortune 2003 Global Most Admired Companies list in the Engineering & Construction class

55. Skanska Products are classified in three categories: permitted products, products that should be phased out and non-permitted products. In total more than 7,500 chemical products have so far been evaluated in the Skanska Group. World wide BFR free policy

56. Skanska chemical policy Total number of evaluated products for the years 2002 2001 2000 4,843 4,749 3,184 Approved 2,174 2,249 1,415 Approved ( but under Surveillance) 1,546 1,540 956 To be phased out 1,026 878 765 Restricted 12 11 8

57. Minolta�s Green procurement �In December 2000, Minolta established the Minolta Green Procurement Guidelines and started to procure environment-conscious parts and materials to be used in Minolta products. An extensive phase out list was given to all suppliers.�

58. Endocrine disruptors major driver in late 1990s in Europe �Nonyl Phenol Ethoxylate phase-out in the UK is moving much faster than the CES report suggests, driven by some manufacturers and retailers who are quietly removing APEs from their products in response to concern about their oestrogenic effects.� Colgate, Palmolive and Procter and Gamble have removed APEs from all or part of their personal care ranges, while Boots and Sainsbury are in the process of reformulating products.

59. NGO campaigns major driver Environmental group, Gron Information, in Denmark published a list of products containing APEs (alkyl phenol ethoxylantes) and other potentially hazardous substances on the Internet in early 1997 Colgate responded that the product listed was an old one which no longer contains APEs and that none of its personal care products sold in the UK now contain APEs. P&G replied that it did not add APEs to any product in [its] Pantene or Vidal Sassoon hair care ranges manufactured for the UK or Denmark.

60. Highly effective NGO campaigns: Friends of the Earth UK �Risky Chemicals Campaign� Greenpeace UK�s HouseHold Dust campaign Both used substantial OSPAR List of Priority Chemicals and targetted common products based on OSPAR list of hazardous chemicals

61. Ospar List ofSubstances for Priority Action Polychlorinated dibenzodioxins (PCDDs) Polychlorinated dibenzofurans (PCDFs) Polychlorinated biphenyls (PCBs) Polyaromatic hydrocarbons (PAHs) Pentachlorophenol Short chain chlorinated paraffins Hexachlorocyclohexane isomers Mercury and organic mercury compounds Cadmium Lead and organic lead compounds Organic tin compounds Nonylphenol ethoxylates and related substances Musk xylene Brominated flame retardants Certain phthalates � dibutylphthalate and diethylhexylphthalate

62. Some feedback from companies (CPA research): Progressives happy to report progress (H&M, IKEA, Swedish/German reps for Fujitsu/Siemens, Marks and Spencer) Small retailers have some frustration that they cannot demand faster substitution from chemical suppliers such as Hoechst, Bayer, GE Plastics Some retailers have frustration that they do not know the product ingredients of the substitutes for their banned lists

63. Some feedback� Business to Business setting up shared lists and requirements Not willing to divulge �confidential� information on substitutes Not willing to advertise alternatives since cannot guarantee complete safety and fear NGO possible attack/criticism (also would have to admit previous use of harmful substance)

64. What regulatory push in absence of substitution principle? Idea of Substitution Assessment Plans Builds on success of MA TURA: Between 1990-1999 (Production-Adjusted quantity Change) Companies reduced toxic chemicals by 41%; achieved an 87% reduction in toxic emissions; saved over $15 million while reducing hazards from facilities. Would make planning mandatory Would allow focus on large list of chemicals; not just half a dozen Results of MA TURA over ten years: Results of MA TURA over ten years:

65. Conclusion: Substitution is feasible and progressive companies are implementing CAUTION: Don�t set your sights too low! No level playing field but EU increasingly setting global standards Double standards between North America and EU very apparent (both company and policy) Need incentives here to bring out more Green Chemistry successes

66. For more information: Bev Thorpe Clean Production Action Tel: 514 484 8647 www.cleanproduction.org Bev@cleanproduction.org