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29 ELR 10515 | Environmental Law Reporter | copyright © 1999 | All rights reserved European Community: Product-Related Regulation and LiabilityRod Hunter and Koen MuylleEditors' Summary: This Article is the third and final installment of a survey of European Community (EC) environmental law. The first Article, which was published in the September 1998 edition of ELR's News & Analysis, discussed the evolving European treaties and institutions. The second Article, published in the June 1999 issue of News & Analysis, analyzed the particulars of the European environmental regulatory scheme by discussing production-related regulation. This Article continues the analysis of European environmental regulations by focusing on product-related regulation. In addition to discussing labeling rules and product take-back regulation, the Article also covers the regulation of chemicals and of genetically modified organisms. The Article then wraps up the three-part analysis of European environmental law with a discussion of the EC's proposed environmental liability scheme. The text of all three of these Articles, as well as supporting European directives, can be found in the Environmental Law Institute's European Community Deskbook, 2nd Edition. Mr. Hunter is a partner in the Brussels office of Hunton & Williams and heads the firm's European regulatory practice. Mr. Muylle serves as legal advisor to the Belgian Senate and was previously an associate in the Brussels office of Hunton & Williams. Over the past decade the European Community (EC) has experimented with new types of product regulation, in particular with regard to consumer goods such as packaging, batteries, vehicles, and electronics.1 Though since the late 1960s the EC has had its own regulatory scheme for chemicals, the European Commission is now contemplating a major revision of that well-established scheme. Further, while the EC adopted legislation on genetically modified organisms in the early 1990s, part of that regulatory framework was recently amended, and the other part is the subject of a controversial amendment process. And, despite severe criticism and opposition from major member states, the Commission has persistently endeavored for now a full decade to convince the EC to promulgate a Community environmental liability scheme. This Article examines these areas of EC environmental law. It begins by discussing labeling rules, including both general consumer labeling rules and eco-labeling schemes. The Article then discusses product take-back legislation for packaging, batteries, vehicles, and electronics, an area in which European officials have been eager innovators. It then reviews the EC's chemicals regulatory framework. The Article goes on to examine genetic modification regulation, a policy area in which political debates are generating considerably more heat than light. Lastly, the Article focuses on the Commission's ambitious attempts to induce the EC legislature to adopt an environmental liability scheme. This last decade, consumers have developed a growing "environmental awareness" and an increasing interest in "environment friendly" products. In response to this tendency, manufacturers started marketing "green products" and made certain claims as to the reduced environmental impact of their products (e.g., biodegradable packaging, reduced energy consumption, etc.). These claims were initially regulated only by general legislation on misleading advertising.2 In the recent past, however, the Community has adopted specific rules for certain products.3 Directive 84/450 on Misleading Advertising requires that advertisements not mislead consumers.4 To determine whether claims made concerning a product, for instance its reduced environmental impact, are misleading, one must take into account the product's characteristics, composition, method of manufacture, and test results.5 The directive requires member states to organize a judicial or administrative procedure to enable consumers and competitors to complain about misleading advertising. Directive 92/75 on Energy Consumption of Household Appliances6 imposes a labeling requirement on suppliers of the following household appliances: refrigerators, freezers, washing machines, dryers, dishwashers, ovens, water heaters, lighting sources, and air conditioning appliances.7 These appliances must carry a label with information relating to consumption of electricity, of other forms of energy, and of other essential resources (like water). Suppliers also have to provide a product sheet with this information and have to possess a technical file enabling inspectors to verify the accuracyof information on the label and the product sheet. The directive foresees that subsequent implementing directives will determine, for each type of household appliance, the detailed information the label and product sheet must contain, as well as the locations where the label should be affixed and the product sheet be publicized.8 Directive 2092/91 on Organic Production of Agricultural Products and Indications Referring Thereto on Agricultural Products and Foodstuffs9 regulates claims that fruits or vegetables have been produced and harvested using "organic" methods. Farmers may refer to an organic production method only when they produce according to the directive.10 They may, for instance, use only those pesticides, herbicides, fertilizers, and soil improvers that are listed in the directive's Annexes I and II. Parasites, disease, and weeds may be eliminated only by using an appropriate choice of species and varieties, a change in crops, mechanical cultivation methods, natural enemies, or fire.11 The Commission recently issued a recommendation concerning good environmental practice for household laundry detergents,12 which urges manufacturers to provide consumers with information to encourage correct use of house-hold laundry detergents.13 The detergent industry elaborated a code of conduct containing measures such as more detailed labeling, educational advertising, and other programs to increase consumer awareness. The Commission also proposed a Directive Relating to the Availability of Consumer Information on Fuel Economy in Respect of the Marketing of New Passenger Cars.14 The proposal would enjoin member states to ensure that a fuel economy label is attached "in a clearly visible manner" to the windshield of all new passenger cars at the point of sale.15 The fuel economy label would contain the official fuel consumption and the official specific emissions of carbon dioxide (CO2), which are to be determined in accordance with Directive 80/1268 on the Approximation of the Laws of the Member States Relating to the Fuel Consumption of Motor Vehicles.16 The label should also include an estimate of the fuel costs associated with driving a distance of 10,000 kilometers or 6,000 miles for the particular vehicle and fuel type in question.17 The proposal would oblige car dealers to provide customers, free of charge, with a fuel economy guide that contains, in addition to the information already on the label, "a prominent listing of the 10 most fuel-efficient new car versions ranked in order of increasing specific emissions of CO2 for each fuel type (fuel and diesel)."18 Dealers would also have to display a poster "in a prominent position" listing the official fuel consumption data and official specific CO2 emission data of the passenger cars they sell.19 Several member states have developed eco-label schemes. The German eco-label, the "Blue Angel," was created in 1977 and is widely used. The "Nordic Swan," the Scandinavian eco-label used in Finland, Iceland, Norway, and Sweden is also very well-known in those countries. Other member states that have set up their own eco-labels include Austria, France, Spain, and the Netherlands. Producers, wanting to use the label in the member states concerned were obliged to design specific packaging for each member state. This undermined the attractiveness and effectiveness of the several eco-labels. Moreover, the eco-label criteria were sometimes drafted in such a way as to provide an advantage to local producers. In 1992, the EC adopted a regulation creating an additional eco-label scheme, Regulation 880/92 Establishing a Community Eco-Label Scheme.20 According to Regulation 880/92, a Community eco-label can be awarded to products meeting requirements defined for a given product group.21 The decision to define product groups and specific ecological criteria for each group is made by the Commission using the comitology procedure.22 Ecological criteria for each product group are defined using a life-cycle assessment (LCA) of the environmental impact of the product. That is, the environmental impact in each phase of a product's life cycle—manufacture, use, and disposal—is to be analyzed.23 The criteria, which are to be revised every three years,24 are to aim for a high level of environmental protection. So far, the Commission has established eco-label criteria for 12 product groups.25 Manufacturers that want to affix the Community eco-label must apply to the national "competent body" of the member state in which the product is manufactured, marketed, or first imported.26 National authorities may award [29 ELR 10518] the eco-label only to products meeting the conditions established by the Commission. The Community eco-label may under no circumstances be awarded to products classified as "dangerous" pursuant to Directives 67/54827 and 88/37928 (Community chemical laws) or to products manufactured using processes that are likely to harm significantly man and/or the environment.29 When a national "competent body" intends to award the eco-label, it has to inform the Commission, which may object to the award.30 This procedure is to ensure a uniform application of the criteria established by the Commission. In September 1998, 216 products had received a Community eco-label. When the Commission proposed Regulation 880/92, it aspired to establish a Community eco-label that would ultimately displace the several national eco-labels. However, rather than replacing the national eco-labels, the Community eco-label has effectively been cutmarketed by them. Furthermore, national officials remain attached to their domestic schemes. Thus, the Commission's proposal for changes to the Community eco-label award scheme seeks to ensure the complementarity between the Community and national eco-label schemes.31 Take-back legislation began with Germany's 1991 regulations requiring collection of packaging waste either by the person who put the packaging on the market or by a nationwide collection scheme in which that person participates. This German packaging scheme spawned initiatives in France, the Netherlands, and elsewhere. Confronted with a splintering market, the European Commission had little choice but to intervene with its own packaging legislation. Although the Community directive is meant to prevent trade barriers, it tolerates widely differing national schemes. The result is a market in which companies have to deal with both EC-driven rules and national variations. Community and national governments are now extending the take-back model from packaging to other consumer goods, most notably vehicles, batteries, and electronics. There are now Commission proposals to impose take-back requirements for vehicles and electronics, and there are European and national measures on batteries, vehicles, and electronics. Indeed, the environment policy committee of the Organisation for Economic Cooperation and Development (OECD) is conducting a series of workshops with a view to preparing guidance for governments on how to design such schemes for virtually any consumer product.32 The Packaging and Packaging Waste Directive,33 adopted on December 20, 1994, on the basis of Article 100a of the EC Treaty, is intended to facilitate the free movement of goods within the Community. The directive, which was to have been implemented by member states by June 15, 1996, covers "all packaging placed on the market … and all pack-aging waste, whether it is used or released at industrial, commercial, office, shop, service, household or any other level …."34 The directive defines packaging broadly as "all products made of any materials of any nature to be used for the containment, protection, handling, delivery and presentation of goods, from raw materials to processed goods, from the producer to the user or the consumer."35 This definition is then limited to include only those materials falling into one of the following categories: (a) sales packaging or primary packaging, i.e.[,] packaging conceived so as to constitute a sales unit to the final user or consumer at the point of purchase; (b) grouped packaging or secondary packaging, i.e.[,] packaging conceived so as to constitute at the point of purchase a grouping of a certain number of sales units whether the latter is sold as such to the final user or consumer or whether it serves only as a means to replenish the shelves at the point of sale … ; and (c) transport packaging or tertiary packaging, i.e.[,] packaging conceived so as to facilitate handling and transport of a number of sales units or grouped packagings in order to prevent physical handling and transport damage ….36 Essential Requirements, Heavy Metals, and Conformity Assessment [] "Essential Requirements." The Packaging and Packaging Waste Directive requires that, from December 31, 1997, member states shall ensure that packaging may be placed on their national markets only if the packaging complies with the directive's "essential requirements."37 These essential requirements are set forth in the vaguest of terms in the directive's Annex II, and they relate to the composition of packaging and to its reusability and recoverability (e.g., "Packaging shall be so manufactured that the packaging volume and weight be limited to the minimum adequate to maintain the necessary level of safety, hygiene and acceptance for the packed product and for the consumer."38). The basic points are that packaging must, by 1998, be either recoverable or reusable, in order to be placed on the market, and that officials and standards writers have broad latitude to define further requirements regarding composition and the meaning of reusable and recoverable. The directive further requires that member states presume compliance with the directive's essential requirements when the packaging complies with the relevant harmonized standard, or, when no harmonized standard exists, [29 ELR 10519] with the relevant national standard (references to which have been published in the EC Official Journal).39 The Committee for European Normalization (CEN) is now working on European (i.e., harmonized) standards to define the directive's essential requirements. In December 1994, the Commission delivered a mandate to CEN to produce these standards. In January 1999, CEN's Technical Committee 261 (TC 261) issued five packaging standards and a guidance document. These proposals are now being subjected to review and comment by national and Commission officials. [] Heavy Metals. The directive requires member states to prohibit manufacturers from placing on their national markets packaging that exceeds the directive's heavy metal thresholds.40 The directive provides that "the sum of concentration levels of lead, cadmium, mercury and hexavalent chromium present in packaging or packaging components" shall not exceed * 600 [parts per million (ppm)] by weight as of July 1998; * 250 ppm by weight as of July 1999; and * 100 ppm by weight as of July 2001.41 The European Commission may however promulgate decisions regarding, inter alia, when these concentrations do not apply to "recycled materials" and "product loops which are in a closed and controlled chain."42 [] Proposed Conformity Assessment Procedure. The Commission submitted in late 1996 a proposed Directive on Marking of Packaging and on Establishment of a Conformity Assessment Procedure for Packaging.43 Under the proposed conformity assessment procedure, manufacturers would be obliged to keep technical documentation—including a general description of the product, conceptual designs, and manufacturing drawings—a list of standards applied, and the results of calculations and tests carried out in order to demonstrate conformity with the "essential requirements." There would be an exception regarding the conformity assessment procedure, however, where neither the manufacturer nor his authorized representative is established within the Community. In such a case, "the obligation to keep the technical documents available [to assess the conformity with the essential requirements] is the responsibility of the person who places the product on the Community market."44 Packaging Marking and Material Identification On the basis of the Packaging and Packaging Waste Directive, Article 8, the Commission adopted on January 28, 1997, a Packaging Material Identification System Decision.45 This decision creates, in its annexes, a numbering and abbreviation system to facilitate identification and classification of packaging materials (i.e., plastics in Annex I, paper and fiberboard in Annex II, metals in Annex III, wood materials in Annex IV, textile materials in Annex V, glass in Annex VI, and composites in Annex VII). The Commission intends to review periodically the identification system and will, according to the Commission's Decision, "if necessary, revise it."46 The use of this numbering and abbreviation system is at present voluntary, though the Commission may subsequently seek to make it mandatory. Return, Collection, and Recovery Systems The Packaging and Packaging Waste Directive sets a series of arbitrary targets for the recovery and recycling of packaging wastes within individual member states.47 To achieve the targets, the directive obliges member states to set up packaging return, collection, and recovery systems.48 The obligations are, however, written in general terms so as to allow national governments broad latitude in structuring their own systems. Specifically, the directive requires national governments to ensure that systems are set up to provide for: (a) the return and/or collection of used packaging and/or packaging waste from the consumer, other final user, or from the waste stream in order to channel it to the most appropriate waste management alternatives; [and] (b) the reuse or recovery including recycling of the packaging and/or packaging waste collected ….49 Thus, in order for a company to ascertain its return, collection, and recovery obligations, it must examine national requirements in each member state where its products are packaged, distributed, or sold. Directive 91/157 on Batteries and Accumulators Containing Certain Dangerous Substances50 bans the marketing of certain batteries and accumulators, creates labeling obligations for battery and accumulator producers, and requires member states to establish separate collection systems for batteries and accumulators. The directive's marking and separate collection obligations apply to batteries and accumulators [29 ELR 10520] falling within the definition of "battery or accumulator." That term is defined as "a source of electrical energy generated by direct conversion of chemical energy and consisting of one or more primary (non-rechargeable) batteries or secondary (rechargeable) cells, as listed in Annex I."51 Annex I lists the following: Batteries and accumulators [ [ containing: —more than 25 mg mercury per cell, except alkaline manganese batteries —more than 0,025 % cadmium by weight [or] —more than 0,4 % lead by weight [and] Alkaline manganese batteries containing more than 0,025 % mercury by weight ….52 This directive was expanded by a December 1998 Commission directive, which is to be implemented by member states by January 2000.53 This Commission directive expands the scope of Directive 91/157 to cover batteries and accumulators put on the market from January 1999 containing more than 0.0005% of mercury by weight.54 The directive prohibits the marketing of the following: —alkaline manganese batteries for prolonged use in extreme conditions (e.g. temperatures below 0° C or above 50° C, exposed to shocks) containing more than 0,05 % of mercury by weight [and] —all other alkaline manganese batteries containing more than 0,025 % of mercury by weight.55 However, "alkaline manganese button cells and batteries composed of button cells" are exempted from this prohibition.56 The Commission recently revised this marketing ban provision. The ban now provides that member states shall prohibit, from January 1, 2000, the "marketing of batteries and accumulators containing more than 0,0005% of mercury by weight, including in those cases where these batteries are incorporated."57 The new provision goes on to state that "button cells and batteries composed of button cells with a mercury content of no more than 2%"58 are exempted from this marketing prohibition. Member states are to ensure that batteries and accumulators and, "when appropriate," appliances into which they are incorporated are "marked." The marking must include indications as to the following points: —separate collection —where appropriate, recycling [and] —the heavy-metal content.59 The Commission has adopted a decision setting out, in detail, this marking obligation. Under the Commission's decision, the symbol indicating separate collection consists of a crossed-out trash can, and the symbol indicating the heavy metal content consists of the chemical symbol for the metal concerned-mercury (Hg), cadmium (Cd), or lead (Pb), according to the type of battery or accumulator concerned.60 The crossed-out trash can symbol must cover 3 percent of the area of the largest side of the battery or accumulator, up to a maximum size of 5 centimeters (cm) x 5 cm. For cylindrical cells, the symbol must cover 3 percent of one-half the surface area of the battery or accumulator and must have a maximum size of 5 cm x 5 cm. If the size of the battery or accumulator is such that the symbol would be smaller than 0.5 cm by 0.5 cm, the battery or accumulator need not be marked, but a symbol measuring 1 cm x 1 cm shall be printed on the packaging. The chemical symbol must be printed beneath the crossed-out trash can and must cover an area of at least one-quarter the size of the crossed-out trash can symbol.61 The directive prohibits the incorporation of batteries and accumulators into appliances "unless they can be readily removed, when spent, by the consumer."62 This prohibition, according to the directive, does not apply to the following categories of appliances: 1. those appliances whose batteries are soldered, welded or otherwise permanently attached to terminals to ensure continuity of power supply in demanding industrial usage and to preserve the memory and data functions of information technology and business equipment, where use of the batteries and accumulators [covered by this directive] is technically necessary[;] 2. reference cells in scientific and professional equipment, and batteries and accumulators placed in medical devices designated to maintain vital functions and in heart pacemakers, where uninterrupted functioning is essential and the batteries and accumulators can be removed only by qualified personnel[; and] 3. portable appliances, where replacement of the batteries by unqualified personnel could present safety hazards to the user or could affect the operation of the appliance, and professional equipment intended for use in highly sensitive surroundings, for example in the presence of volatile substances.63 "Those appliances the batteries and accumulators of which cannot be readily replaced by the user, … , shall be accompanied by instructions informing the user of the content of [29 ELR 10521] environmentally hazardous batteries and accumulators and showing how they can be removed safely."64 The directive requires that member states ensure that "spent batteries and accumulators are collected separately with a view to their recovery or disposal."65 The directive further provides that member states shall ensure "the efficient organization of separate collection and, where appropriate, the setting up of a deposit system."66 These very vague separate collection requirements have resulted in a great deal of variety in national implementation, with about one-half the member states imposing some version of a take-back obligation on manufacturers and importers. The directive grants the Commission, working with the technical adaptation committee under Directive 75/442 on Waste, broad powers to revise the scope and substantive standards of the directive. Specifically, the Commission may revise the list of types of batteries and accumulators covered by the directive, the list of appliances excluded from the directive, the scope of marketing prohibitions, and the separate collection and marking obligations.67 The Proposed End-of-Life Vehicles Directive68 would apply to the following: (1) passenger vehicles, with no more than eight seats in addition to the driver's seat; (2) vehicles for carriage of goods having a mass not exceeding 3.5 tons; (3) two- and three-wheeled vehicles; (4) special purpose vehicles (defined in Article 4(1)(a) of Directive 70/156); and (5) all such vehicles' components and waste.69 This proposal has been the subject of animated political debate in the EC legislative process, which nearly resulted in the resignation of the German environment minister.70 The proposed directive includes a number of product standards, as well as invitations to member states to adopt their own product-related measures. [] Metals Restrictions. In a curiously drafted provision, the proposed directive provides that "lead, mercury, cadmium and hexavalent chromium contained in vehicles put on the market after 1 January 2003" shall not be "shredded in vehicle shredders" and not "disposed of as landfill or in any installation incinerating or co-incinerating waste, with or without energy recovery."71 Lead used as solder in circuit boards, however, is exempted from this effective ban.72 Under this peculiar provision, one apparently could sell cars containing the metals after January 2003, but they could not be shredded. And one could shred cars containing the metals, but only if they were first sold before 2003. [] Design and Material Choice. The proposed directive would instruct member states to encourage or require producers to do the following: * "to control the use of hazardous substances in vehicles and to reduce them as far as possible from the conception of the vehicle onwards, so as to prevent their release into the environment, make recycling easier, and avoid the disposal of hazardous waste"; * to "design and produce … new vehicles [so as to take] into full account and facilitate[] dismantling, re-use and recovery, in particular recycling, of end of life vehicles, their components and materials"; and * "to integrate an increasing quantity of recycled material in vehicles and other products, in order to develop the market for recycled materials."73 Thus, this proposal contemplates each member state making its own product regulation measures. It is hard to see how member states could impose any such measures without causing regulatory trade barriers. [] Type-Approval Standards. In order to achieve the proposed directive's reuse and recovery targets,74 the Commission is to propose legislation amending EC vehicle type-approval regulations so that vehicles placed on the market after January 2005 are "re-usable and/or recoverable to a minimum of 95% by weight per vehicle."75 In this connection, the Commission is also to promote European standards on "dismantability, recoverability, and recyclability of vehicles."76 [] Material Coding. The proposed directive requires that "producers, in concert with material and equipment manufacturers, use common component and material coding by 31 December 1999, in particular to facilitate the identification of those components and materials which are suitable for re-use and recovery."77 The Commission is to promote [29 ELR 10522] European standards on "the identification and codification" of such components and materials.78 Producers (defined to include the "vehicle manufacturer" and "professional importer")79 would be obliged to take-back all of their vehicles at no cost as of January 2003.80 In order to ensure that consumers return end-of-life vehicles, member states are to establish de-registration systems. To de-register and stop paying tax on a vehicle, the owner would need to obtain a "certificate of destruction" on turning the defunct vehicle over to a permitted treatment facility.81 The proposed directive requires that facilities carrying out "treatment operations" shall obtain a waste permit under EC waste legislation.82 Notwithstanding provisions of EC waste legislation allowing member states to require only registrations for certain low risk activities, these treatment facilities must obtain a full waste permit. These waste treatment permits are to require the following: * that vehicles must be "stripped (by removal of all fluids, tires, batteries, air-conditioning systems, air bags, catalysts and other hazardous components and materials) before further treatment or other equivalent arrangements shall be made in order to reduce the adverse impact …"83 * that "components containing lead, mercury, cadmium and hexavalent chromium in vehicles put on the market after 1 January 2003 shall also be stripped before further treatment"84 * that "materials and components shall be removed and/or treated in a selective way so that shredder waste is not classified as hazardous waste"85; [and] * that "stripping operations and storage" are conducted in such a way as to "ensure the suitability of vehicle components for re-use and recovery, and in particular recycling."86 The proposed directive would impose a rigid waste management hierarchy. It would require that "components suitable for re-use are reused, that components which cannot be reused are recovered andthat preference is given to [material] recycling when environmentally viable, without prejudice to safety requirements."87 It is worth noting that this cascade of reuse, material recycling, and energy recovery obligations does not include an economic qualifier. The Commission hopes to require "reuse" of components when possible, material recycling only when reuse is not possible, and energy recovery only when material recycling is not "environmentally viable," and disposal only when there is no other technically possible solution. The fact that, say, material recycling may in a particular case be excessively costly is, by the proposed directive's terms, irrelevant. The proposed directive sets out a series of reuse and recovery targets to be met by 2005 and 2015. The targets for 2005 are as follows: * re-use and recovery (which includes material recycling and energy recovery) of 85 percent by weight per vehicle; and * re-use and material recycling of 80 percent per vehicle (i.e., only 5 percent energy recovery).88 The targets for 2015 are as follows: * re-use and recovery to 95 percent by weight per vehicle; and * re-use and material recycling of 85 percent by weight per vehicle.89 The selection of these targets was political. There was little close analysis of whether and how these targets would produce a better, more efficient environmental policy. Rather, the intention was to use ambitious targets to drive reuse and recovery by individual manufacturers. The proposed directive would require member states to develop "data-bases on end of life vehicles and their treatment."90 Such data collection is a necessary consequence of setting industrywide collection and reuse/recycling targets, for the Commission and other member states will want to verify whether a member state is meeting its targets. As in the packaging context, this will result in extensive reporting obligations for individual manufacturers. And each country will have its own reporting obligations. (Belgium has three different sets of packaging reporting requirements, one for each region.) The administrative burdens for producers will be considerable. In addition to these reporting obligations, producers are "to publish information on the rates of re-use, recycling and [29 ELR 10523] recovery which have been achieved in the previous year for their vehicles and components."91 This information is to be "made available to potential purchasers of vehicles."92 The Commission hopes that the general availability of such information will lead to producers competing to achieve ever higher levels or reuse and recovery. The European Commission's Waste Unit recently circulated a draft Proposal for a Directive on Waste From Electrical and Electronics Equipment.93 The draft directive would: (1) apply to virtually all electronics (including consumables); (2) regulate the content of electronics, including banning the use of lead, mercury, cadmium, hexavalent chromium, and halogenated flame retardants; (3) require marking; (4) impose take-back obligations on distributors and producers; and (5) impose extensive annual reporting obligations on producers. Commission staff hopes to have the draft directive adopted as a formal Commission proposal by the autumn of 1999. The proposal would then be considered by the Parliament and Council. If past experience is a guide, it would take 18 to 24 months for the proposal to be enacted, with the rules coming into force two years later in, say, 2003 or 2004. The draft directive would apply to "electrical and electronic equipment," which is defined broadly to include "equipment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measurement of such currents and fields falling under the categories set out in Annex 1A [to the directive]."94 The draft directive specifies that electrical and electronic equipment includes "all components and subassemblies which are part of the product as well as [listed] consumables."95 Annex 1A lists a broad range of products, including the following: * large household appliances; * small household appliances; * IT equipment (e.g., computers); * telecommunication equipment; * radio, TV, electroacoustic, and musical instruments; * lighting equipment; * medical equipment systems; * monitoring and control equipment; * toys; * electrical and electronic tools; and * automatic dispensers. Thus, in contrast to some national measures (e.g., the proposed German information technology ordinance), the draft directive's product standards and take-back obligations would apply to virtually all products through which electric current passes. Indeed, the Commission's proposal, as written, could cover products that are not themselves electrical or electronic. The draft says it would apply to "consumables"96 listed in Annex II. This list includes, for example, ink and toner cartridges, and records and tapes. The draft directive would create a series of product standards and labeling requirements that would be obligatory for those seeking to place their products on the European market. [] Bans. The draft directive would require that "the use of lead, mercury, cadmium, hexavalent chromium and halogenated flame retardants is phased out" by 2004.97 A strict reading of this language might lead one to conclude that even consumers would have to stop "using" products containing the prohibited substances as of 2004. It is unlikely that the Waste Unit would mean to go so far. The draft directive would, however, exempt from this ban several applications listed in Annex II.98 It would then allow the Commission, working with national officials through a technical adaptation committee, to modify the exemption list.99 However, the draft directive would impose no restraints guiding the exercise of this delegated rulemaking authority—that is, in granting exceptions, the Commission and national officials would not need to consider economic viability and would not need to provide much explanation for their decisions. There would hence be virtually no possibility for obtaining judicial review. [] Product Design and Content. The draft directive would require member states to "ensure that the share of recycled plastic in new electrical and electronic equipment amounts to at least 5% of the total plastic content by 1 January 2004."100 The draft directive also contemplates that the Commission will propose legislation setting revised minimum recycled plastic content levels effective January 2006. The draft directive would instruct the 15 different member states to encourage or require producers to do the following: * "to minimize, as far as possible, the use of dangerous substances and preparations [i.e., anything classified as dangerous under EC chemical rules], as well as the number of different types of plastics in individual items"; and * to "design and produce … electrical and electronic equipment [so as to take] into full account and facilitate[] their repair, possibility to be upgraded, re-use, dismantling and recycling [and in particular] to increase the use of materials which can be easily recycled."101 Thus, this proposal foresees each of the member states taking its own product regulation measures. This is an invitation to balkanization of the EC market, with each of the several member states promulgating its own product regulations. The draft directive would also invite the Commission to "promote, as appropriate," preparation of European standards on "design of electrical and electronic equipment" according to the above sentiments.102 These standards, which would be prepared by the CEN, could become the detailed product regulations that manufacturers will need to design their products to meet in order to market the products in Europe. [] Labels and Plastics Marking. The draft directive would require that certain equipment (i.e., all equipment, except large household appliances and automatic dispensers) and consumables be marked with the crossed-out dustbin symbol used for certain batteries in Europe.103 The draft directive would instruct member states to ensure that producers use "common component and material coding standards, in particular to facilitate the identification of those components and materials which are suitable for re-use and recycling."104 More specifically, members states are to require that plastic parts be marked in accordance with International Organization for Standardization (ISO) 11469, but only when parts weigh more than 25 grams.105 The draft directive would require producers to establish "systems so that last holders and distributors can return end of life electrical and electronic equipment."106 The draft directive would set the collection targets, but the targets would concern only equipment from private households.107 The draft directive states that member states shall "aim at achieving a minimum rate of separate collection of 4 [kilogram (kg)] on average per inhabitant per year of end-of-life equipment from private households."108 While this would not appear to be a mandatory threshold, the draft contemplates that the Commission will propose a directive by 2006 setting compulsory collection targets for equipment from households. This staged approach would at least allow the Commission to base its targets on some empirical data. The draft directive would require member states to ensure "pre-treatment … prior to the landfilling, incineration or recovery of separately collected end-of-life electrical or electronic equipment."109 That is, pretreatment would be necessary only where the product will not be reused as is. As for who is responsible for treatment, the draft would require that "producers set up systems to provide for the pretreatment of … equipment that is separately collected and destined for landfilling, incineration or recovery."110 This pretreatment must include removal of fluids and selective treatment according to Annex IV. The draft directive requires that facilities carrying out "treatment operations" shall obtain a waste permit under Community waste legislation.111 Notwithstanding provisions of EC waste legislation allowing member states to require only registrations for certain low risk activities, these treatment facilities must obtain a full waste permit. The draft directive requires that treatment facilities shall store and treat equipment in compliance with a series of "technical requirements" concerning construction and operation. The Commission, working with national officials in the technical adaptation committee, would be able to amend and expand these "technical requirements" for treatment facilities, as well as the detailed "selective treatment" for equipment.112 The draft directive may, however, create confusion with regard to the export of collected products. The draft directive specifically states that the treatment operations "may also be undertaken outside the respective Member State or the [European Union (EU).]"113 "Treatment" is defined to include "recovery and/or disposal."114 With regard to recovery beyond Community borders, it was already clear that waste shipment rules did not preclude export from the EC of collected equipment, at least to OECD countries. However, those rules prohibit exports of "waste" for disposal to countries outside of Europe (i.e., EC and European Free Trade Area (EFTA) countries). It may be that the drafters merely meant for this provision to make clear that recycling of exported collected products may be counted in determining whether a member state meets its recycling targets. Recovery The draft directive would require producers to "set up systems to provide for the recovery of the separately collected end of life electrical and electronic equipment" and then set a series of ambitious reuse and material recyclingtargets to be achieved by January 2004.115 The targets are expressed as percentages, by weight, of equipment collected. Roughly, large household appliances, gas discharge lamps, products containing cathode ray tubes, and products containing chlorofluorocarbons (CFCs), hydrochlorofluorocarbons (HCFCs) or hydrofluorocarbons (HFCs) would have to be recycled at 90 percent (energy recovery excluded). Other equipment would have to be recycled at 70 percent (energy recovery excluded). One might wonder about the basis of these targets. When questioned during a public meeting with industry and environmental groups, Commission staff referred vaguely to pilot projects conducted in several member states.116 Although there have been a number of pilot projects, these exercises have typically been limited in geography and product ranges.117 It is not clear that these pilot projects serve as a suitable basis for setting legally binding minimum collection and reuse/recycling levels. Even if the Commission's targets were achievable in densely populated and highly developed countries such as Denmark or the Netherlands, one might well question their appropriateness in regions with less developed collection infrastructure. For example, in Greece, with its numerous islands, setting up collection and recovery systems to achieve these targets would likely be more expensive than similar programs in Denmark or the Netherlands. Greek consumers would have to pay more for new equipment, thereby rendering it more difficult for the Greeks to achieve the productivity gains (and resulting wealth increases) from new equipment. As alluded to above under "Collection," the draft directive extends the scope of producers' financing obligations to include not just treatment, recovery, and disposal, but also collection, which will surely be controversial. Moreover, the draft directive makes it clear that producers, at least collectively, are responsible for the financing of old products as well. More specifically, member states are to ensure that "private households can return end of life electrical and electronic equipment free of charge. To this end Member States shall ensure that the costs for collection, treatment, the recovery and the environmentally sound disposal … from private households are borne by producers."118 While member states are to allow producers to create "collective systems to provide for the financing" of household products, member states are to ensure that "producers individually or collectively provide appropriate guarantees" to finance the handling of products placed on the market after the directive's entry into force.119 With regard to pre-legislation products, producers may comply with the take-back and recovery/disposal obligations individually "under the condition that they contribute to the financing of the management of [pre-legislation products]. The share of this contribution shall be in proportion to the individual producer's market share at the time of payment."120 The draft directive would require that "producers provide information yearly on the quantities of electrical and electronic equipment put on the market within the Member States, both by numbers and by weight as well as on the market saturation in the respective product sectors."121 Producers are also to indicate whether equipment is "sold to professional users or private households."122 The multiplicity of national reporting obligations pursuant to the Packaging and Packaging Waste Directive already creates difficulties for manufacturers—the detailed rules differ across the Community, and companies often do not know precisely which of their products end up in which EC countries (free movement of goods was, after all, one of the founding principles of the Community). Not only will these difficulties be at least as troublesome in the context of electronics, but the consequence of these reports will be even greater. As implied by the "Financing" discussion above, these annual reports will serve as the basis for determining each producer's contribution share for financing take-back and recovery of old and new products. The draft directive contemplates, as before, that the Commission, working with a technical adaptation committee made up of national officials, may modify the annexes of the directive. That is, the Commission and the committee could change: (1) the scope of the directive, (2) exceptions from bans, (3) the selective treatment operations for used equipment, and (4) operating conditions for sites for the storage and treatment of used equipment.123 This provision grants the Commission and the committee broad discretion to change legal obligations for producers of new products and handlers of used products. However, given the lack of substantive standards in the directive to guide the Commission and the committee, and given the lack of standing under Community law for private parties, the opportunities for judicial review of such delegated rulemaking would be nearly nonexistent. Chemicals Chemical regulation was one of the first areas of environmental legislation pursued by the Community. The first major initiative, adopted in 1967, erected a common Community system for the classification, packaging, and labeling of dangerous chemical substances, the object being largely to minimize impediments to sales of the substances across the Community. This basic legislation was modified in 1979, by the so-called Sixth Amendment, to impose, as a precondition to the marketing of new "dangerous substances," a prior notification procedure involving the preparation of technical dossiers providing information on the substances' characteristics. Pursuant to the Sixth Amendment, the Commission has compiled a list (known as EINECS) of "existing" substances, substances already on the market before September 18, 1981.124 It has also maintained a list (known as ELINCS) of "new," notified substances, with this list classifying the substances according to their risk characteristics.125 In 1998, the Community adopted analogous requirements for the classification, packaging, and labeling of dangerous preparations (mixtures of dangerous substances). It has also imposed specific requirements on certain harmful materials, such as solvents, paints, varnishes, printing inks, adhesives, and pesticides, and has adopted material safety data sheet rules. It has extended its regulation to include the marketing and use of certain dangerous substances and preparations. In November 1998, the Commission circulated a "working document" reviewing operation of Community chemical legislation.126 The report, which surveys existing regulation, comments on perceived weaknesses and suggests a large number of possible changes. The report will be the subject of a consultation process in which member states and interested parties will be able to submit comments. It would be safe to assume that afterwards the Commission will propose revisions to existing regulations. Classification, Packaging, and Labeling The two key EC chemicals laws are the Directive on Classification, Labelling and Packaging of Dangerous Substances127 and the Directive on Classification, Labelling and Packaging of Dangerous Preparations.128 These directives set forth the Community rules on pre-marketing testing, packaging, and labeling of dangerous substances and preparations and impose certain additional information requirements, including a requirement to provide safety data sheets (SDS). On the basis of the results of tests described in the Dangerous Substances Directive, substances must be classified according to their "intrinsic properties" (not according to actual risk posed or potential for exposure) in 1 of the 15 categories of danger, which are defined with reference to the test results. The classification determines the packaging and labeling of the substance. Classification as "dangerous" requires labeling on the package. The label must include a danger symbol, standard phrases on the special risks of the chemical (R-phrases), and standard safety precaution phrases (S-phrases) concerning use of the substance. A few key terms—namely, "substance," "preparation," and "article" -serve as the main building blocks of Community chemical law. [] Substance. The term "substance" is defined as chemical elements and their compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the products, and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.129 The term "substance" covers polymers. [] Preparation. A "preparation" is defined as "a mixture or solution composed of two or more substances."130 [] Article. A complex, solid product containing substances is not regarded as a "preparation," but rather as an "article," and is effectively excluded from Community chemical legislation. The term "article" is defined in the context of reporting for EINECS as an item which is formed to a specific shape, surface or design during manufacture, has end use function(s) dependent in whole or in part upon its shape or design during end use, and has either no change of chemical composition during its end use or only those changes of composition which have no commercial purpose separate from that of the article.131 Dangerous Substances Directive The Dangerous Substances Directive imposes testing, reporting (notification), labeling, packaging, and information requirements on Community manufacturers and importers of chemical substances. Testing and Notification The Dangerous Substances Directive requires that tests be conducted and notifications be submitted as follows: —for substances manufactured within the Community, by the manufacturer who places a substance either on its own or in a preparation on the market; and —for substances manufactured outside the Community, by any person established in the Community who is responsible for placing the substance either on its own or in a preparation on the Community market [or by the manufacturer's sole representative].132 No notification and, thus no testing, is required for substances that are not "placed on the market." "Placing on the market" is defined as "making available to third parties."133 The Dangerous Substances Directive goes on to provide, however, that importation into the Community "shall be deemed to be placing on the market."134 Notification Procedure and Safeguard Clause Under the Dangerous Substances Directive, unless exempted,135 a Community manufacturer or importer of a substance is required to do the following: * to conduct certain testing to determine the properties of the substance136; and * to notify the national authorities of the member state where the substance is manufactured or first imported.137 The notification must include "the information necessary for evaluating the foreseeable risks, whether immediate or delayed, which the substance may entail for man and the environment, and containing all available relevant data for this purpose."138 Substances regarded as "dangerous" are subject to packaging and labeling requirements. The manufacturer or importer of the substance is responsible for testing, notification, packaging, and labeling of the substance. As noted, the user of the substance (i.e., a manufacturer of products containing substances—so-called articles) is not subject to obligations under this directive. Before a substance is placed on the market, the Community manufacturer or importer of the substance is required to submit a proper notification to the member state in which the substance is manufactured or imported.139 Only a manufacturer or importer established in the Community may be the "notifier."140 The member state receiving the notification serves as an agent of the other member states in reviewing the notification, receiving comments on the notification from the other states, and allowing the substance to be marketed in the Community. Once a substance has been properly notified in the country of origin or first importation, it may be marketed in other member states. The notification must include the following: (1) a technical dossier containing information necessary for evaluating foreseeable risks the substance may entail for man and the environment and the results of tests and studies defined in Annex VII of the directive; (2) a declaration regarding the negative effects of the substance for various uses envisaged; (3) the proposed classification and labeling of the substance; and (4) proposals for recommended safety precautions in the use of the substance.141 Testing is required to develop the technical dossier of information (called the "base set") regarding the chemical's identity, physicochemical properties, potential toxicological and eco-toxicological effects, use, and disposal. The testing requirements are set forth in Annexes VII and VIII of the directive. Annex VII defines the "base set" of information required for the technical dossier. Annex V sets forth the methods for determining the toxicity, eco-toxicity, and physical and chemical properties of the substance.142 Member states are required to send a copy or a summary of the notification dossier to the Commission, which must then forward the dossier to the other member states.143 Member states then have an opportunity to consult either the member state that received the original notification or the Commission regarding the data in the dossier and to suggest that further information be provided or additional tests performed.144 Beyond this vehicle for collaboration between the other national authorities and the notified member state, the other national authorities have only limited recourse should they disagree with the conclusions of the notified member state [29 ELR 10528] concerning the classification, packaging, and labeling of the notified substance. The directive provides that when, "in the light of new information,"145 a member state has "justified reasons"146 to consider that a substance "constitutes a danger for man or the environment by reason of its classification, packaging or labelling,"147 the member state may "temporarily" reclassify or, if necessary, prohibit the placing on the market of that substance, or may subject it to "special conditions" within its territory.148 The member state must immediately inform and give reasons for its decision to the Commission and other member states. The Commission, working through a technical adaptation committee procedure, may adopt a decision regarding the substance and the member state's position (e.g., reclassify the substance).149 Further, if the Commission considers that "technical adaptations" to the directive itself are necessary, those adaptations shall be adopted pursuant to the directive's provisions. Testing and Notification Exemptions Certain substances are "considered as having been notified" and thus are exempted from the testing and/or notification obligations. These exemptions apply only to testing and notification obligations and do not excuse the manufacturer or importer from labeling and packaging obligations. [] Existing Substances. Notification is not required for substances placed on the market before September 18, 1981, and listed in EINECS.150 [] Small Quantities and Research. Notification is not required for: (1) chemicals marketed in quantities less than 10 kg per year per manufacturer; (2) for substances placed on the market for research and analysis in quantities not exceeding 100 kg per manufacturer per year; and (3) chemicals placed on the market for "process-oriented research and development."151 [] Polymers. Notification is not required for polymers, with the exception of those containing, in combined form, 2 percent or more of any substance not on EINECS. Thus, if a polymer contains more than 2 percent of a monomer that was not on the market in 1981, it is not exempted.152 In the case of a previously notified substance, the competent authority may allow a manufacturer preparing the technical dossier, with the written permission of previous notifiers, to use data submitted in prior notifications.153 Community manufacturers and importers have, however, a continuing obligation to inform the competent authority of changes in annual or total quantities of the substance placed on the market, new knowledge regarding health and environmental effects of the substance, new uses of the substance, and any change in the composition of the substance.154 The Dangerous Substances Directive creates packaging and labeling obligations, which, like classification and notification requirements, are triggered by the placing of dangerous substances on the market. The basic obligation is a self-executing duty on Community manufacturers and importers to classify chemical substances. The directive provides that "substances shall be classified on the basis of their intrinsic properties according to the [15] categories" laid down in the directive.155 If a substance is subject to notification, the study results determine its classification. Substances exempted from testing and notification obligations (e.g., polymers and existing substances) are classified on the basis of existing data on their dangerous proprieties. The directive requires that such exempted substances, "in so far as the manufacturer may reasonably be expected to be aware of their dangerous properties,"156 are packaged and provisionally labeled by the manufacturer in accordance with the directive's relevant provisions. In any event, the danger symbol(s) for the label are to be taken from the Directive's Annex II, and the R-phrases and S-phrases result from the classification exercise.157 The Dangerous Substances Directive provides several exemptions to labeling requirements. For example, member states may under certain conditions make exceptions for packages containing small quantities or for small or unsuitable packages.158 This provision does not itself provide an exemption, but merely permits member states to grant such an exemption. Regulation 793/93,159 known as the Existing Substances Regulation, requires reporting of certain data with respect to "existing substances" (i.e., substances listed in EINECS). [29 ELR 10529] Manufacturers and importers were required to provide information on existing substances manufactured in or imported to the Community in excess of 10 tons per year.160 The data collection procedure involved the following steps. During Phase I, ending in June 1994, manufacturers and importers had to submit a complete data set for those existing substances listed in the regulation's Annex I that were produced/imported in excess of 1,000 tons/year ("high production volume" substances). During Phase II, ending in June 1995, manufacturers and importers had to submit a complete data set for other existing substances that were produced/imported in excess of 1,000 tons/year ("high production volume" substances). During Phase III, ending in June 1998, manufacturers and importers had to submit a limited declaration form for existing substances that were produced/imported in volumes between 10 and 1,000 tons/year ("low production volume" substances). As a result of this data collection procedure, the Commission reports that, of the 100,106 EINECS substances, there are about: (1) 2,500 high production volume substances (1,000 tons or more per year); (2) between 15,000 and 20,000 low production volume substances (10 to 1,000 tons per year); and (3) 80,000 substances produced or imported in volumes less than 10 tons per year.161 As for the information that needed to be submitted as noted above, manufacturers and importers had to submit complete data sets for high production volume substances and limited declarations for low production volume substances. Complete data sets included information on: (1) production/importation quantities; (2) classification and labeling information under the Dangerous Substances Directive; (3) reasonably foreseeable uses; (4) physicochemical properties; and (5) toxicological and eco-toxicological properties.162 Limited declarations included information on: (1) production/importation quantities; (2) classification and labeling information under the Dangerous Substances Directive; and (3) reasonably foreseeable uses.163 Reporting on the substances' properties and effects was not necessary. Although the initial reporting deadlines have passed, the regulation does create ongoing reporting obligations. Once a company has reported information on a substance under the regulation, the report must be updated in the following circumstances: * when new uses of the substance lead to substantial changes in human or environmental exposure to it; * when there is new information on its properties or effects that is "likely to be relevant to the evaluation of the potential risk"; * every three years, if the amount produced or imported is no longer in the volume range that the company reported.164 If a manufacturer or importer of an existing substance "acquires knowledge which supports the conclusion"165 that the substance "may present a serious risk to human health or the environment,"166 it must inform the Commission and the member state in which the manufacturer or importer is located. On the basis of the reported information, 3 priority lists, including 110 substances, have been adopted by the Commission.167 The three Commission regulations setting out priority lists attribute each substance to a member state "rapporteur" for evaluation and preparation of a risk assessment report for consideration by other member states. The risk evaluation is to be based on Regulation 1488/94168 and a more detailed Technical Guidance Document published in 1996.169 A risk assessment has the following four major steps: * hazard identification—identification of adverse effect (acute and long-term) that a substance has an inherent capacity to cause on human health and the environment; * dose (concentration)/response (effect) assessment—the estimation of the relationship between dose or level of exposure to a substance, and the incidence and severity of the effect; * exposure assessment—the determination of emissions, pathways, and rates of movement of a substance and its transformation or degradation, in order to estimate the concentrations/doses to which human populations or environmental spheres (water, soil, and air) are or may be exposed; and * risk characterization—the estimation of the incidence and severity of the adverse effects likely to occur in a human population or environmental sphere due to actual or predicted exposure to a substance, possibly including "risk estimation" (i.e., quantification of that likelihood).170 If the conclusion of the risk assessment is that the risks are not adequately managed, the rapporteur state is to propose a strategy for reducing those risks.171 On the basis of the risk evaluation and proposed strategy, the Commission submits a draft recommendation to the regulatory committee on measures to be taken.172 Such measures may, for example, be taken pursuant to Directive 76/769 on Restrictions [29 ELR 10530] on Marketing and Use of Certain Dangerous Substances and Preparations, or Community occupational health and safety legislation. Dangerous Preparations Directive The Dangerous Preparations Directive creates a regulatory framework for preparations (i.e., mixtures of substances) that essentially parallels, and indeed in many regards relies on, the Dangerous Substances Directive's regime for substances. The Community prefers testing of pure substances individually over testing of preparations. Accordingly, one of the preambles to the Dangerous Preparations Directive states that "the assessment of the health hazards of a preparation may be carried out by a calculation method, by determining the toxicological properties according to well-defined tests methods, or by a combination of the two."173 The Dangerous Preparations Directive "entails no obligation to conduct further experiments on animals."174 The physicochemical properties of a preparation must be determined by the methods specified in the Dangerous Substances Directive, unless one of the exemptions applies. The health hazards (this term is not defined, and it is not clear whether it includes eco-toxicity) of a preparation must be assessed by the following: * the conventional mathematical methods described in the Dangerous Preparations Directive, which are based on concentrations limits; or * the testing methods set forth in the Dangerous Substances Directive for determining the toxicological properties necessary for an appropriate classification.175 The latter method (testing) is optional. If it is not used, the conventional method must be employed to determine toxicological properties. If both are used, the results of the tests govern, except in the case of carcinogenic, mutagenic, and teratogenic effects. Actual knowledge of effects on man always override these results, however. Knowledge of potentiation or antagonism must be "taken into account" with the conventional method.176 Thus, preparations must be classified according to the following hierarchy: 1. known effects on man; 2. actual test results for the preparation of tests conducted in accordance with the Dangerous Substances Directive (such tests are required only with respect to physicochemical properties, not for health hazards/toxicological properties); and 3. conventional mathematical methods, taking into account potentiation or antagonism. A dangerous preparation is subject to labeling and packaging requirements on the basis of its classification which, in turn, depends on the classification hierarchy listed above.177 However, as with the Dangerous Substances Directive, the Dangerous Preparations Directive's testing, reporting, labeling, and packaging requirements apply only to preparations that are "placed on the market." In any event, the Dangerous Preparations Directive's labeling requirements are basically taken from the Dangerous Substances Directive (i.e., requirements regarding the use of hazard symbols depending on hazard classification and use of R-phrases and codes and S-phrases and codes).178 Similarly, the packaging rules for preparations have essentially been incorporated from the Dangerous Substances Directive.179 Pursuant to the Dangerous Substances and Dangerous Preparations Directives,180 the Commission has promulgated the Commission Safety Data Sheets Directive.181 The key provision of the Directive reads as follows: Any person established within the Community who is responsible for placing a dangerous substance or preparation on the market, whether the manufacturer, importer or distributor, shall supply the recipient who is an industrial user of the substance or preparation with a safety date [sic] sheet containing [the prescribed information].182 The SDS must be provided free of charge, at the latest when the substance or preparation is first supplied, and must be updated to reflect "any significant new information regarding safety and protection of health and the environment."183 The Safety Data Sheet Directive requires that SDS for dangerous substances and preparations include the following: (1) identification of the substance/preparation and of the company/undertaking; (2) composition/information on ingredients; (3) hazards identification184; (4) first-aid measures; (5) fire-fighting measures; (6) accidental release measures; (7) handling and storage; (8) exposure controls/personal protection; (9) physical and chemical properties; (10) stability and reactivity; (11) toxicological information; (12) ecological information; (13) disposal consideration; (14) transport information; (15) regulatory information; and (16) other information. The term "exposure control" means the full range of precautionary measures to be taken during use in order to minimize worker exposure.185 The Guide to the Compilation of Safety Data Sheets186 attached to the Commission Directive provides further explanation and guidance. The directiveprovides an exception to the SDS requirement when the dangerous substance or preparation is "offered for sale to the general public."187 For this exception to be available, the general public must be "furnished with sufficient information to enable users to take the necessary measures as regards the protection of health and safety."188 Nonetheless, even when the dangerous substance or preparation is offered to the general public, if an "industrial user" requests, an SDS must be provided.189 Concurrent with this legislative initiative on the classification, packaging, and labeling of dangerous substances, the Community has adopted directives on preparations generally,190 as well as on specific preparations. The directives on specific preparations include one on solvents,191 one on paint, varnishes, printing inks, and adhesives,192 and another on pesticides.193 The Community has extended its regulation to include not just the classification, packaging, and labeling of dangerous substances and preparations, but also the marketing and use of dangerous substances and preparations. Directive 76/769 on Marketing and Use of Dangerous Substances and Preparations194 creates a framework requiring member states to restrict or ban the marketing and use of dangerous substances and preparations listed in the directive's Annex I.195 The Annex I list, which can be amended through a technical adaptation committee procedure,196 includes for example: polychlorinated biphenyls (PCBs) and polychlorinated terphenyls (PCTs); monomer vinyl chlorides; trichloroethylene, tetrachloroethylene, and carbon tetrachloride; benzene; cadmium; and asbestos. In this Annex, use restrictions or bans are specified for the listed substances. Genetically Modified Organisms The Community regulates environmental, health, and safety concerns arising from genetically modified organisms (GMOs) through four "horizontal" directives—Directive 90/219 on Contained Uses,197 Directive 90/220 on Deliberate Releases,198 Directive 90/679 on Biological Agents at Work,199 and Directive 94/55 on Transport of Dangerous Goods by Road200—and through "sectoral" legislation—the [29 ELR 10532] Novel Foods Regulation.201 The two fundamental directives—Directive 90/219 on Contained Uses and Directive 90/220 on Deliberate Releases, which have been at the center of much heated debate since their adoption in 1990—create the basic regime governing both manipulation of GMOs in laboratories and their release into the environment.202 Directive 90/219,203 which was substantially modified in late 1998,204 regulates contained uses of genetically modified microorganisms (GMMs) and sets forth rules for prior risk assessment and conditions of use. Given that the new contained use requirements do not need to be implemented by member states until mid-2000, this section first describes the existing regulatory requirements before turning to the new rules. Directive 90/219 creates notification and authorization procedures for GMM-installations and GMMs (a number of member states apply these contained use rules to GMOs, as well as GMMs). The directive's scope is not limited to a specific activity—"contained use" includes any operation in which [microorganisms] are genetically modified or in which such [GMMs] are cultured, stored, used, transported, destroyed or disposed of and for which physical barriers, or a combination of physical barriers together with chemical and/or biological barriers, are used to limit their contact with the general population and the environment.205 The term "genetically modified microorganism" is defined as "any [microorganism] in which the genetic material has been altered in a way which does not occur naturally by mating and/or natural recombination."206 This GMM definition centers on the human intervention (i.e., genetic engineering) and distinguishes such engineering from "natural" processes such as mating and recombination. Under this definition, if alterations are made to genetic material and such alterations also occur naturally, the resulting organism would not be considered a GMM. The term "microorganism" is defined as "any [microbiological] entity capable of replication or of transferring genetic material."207 The directive classifies GMMs into Group I (presumed to pose low risks) and Group II (presumed to pose higher risks).208 Activities involving GMMs are divided into Type A (small scale209 operations used for teaching, research, development, or nonindustrial/commercial purposes) and Type B activities (other operations).210 These classifications are to be made on the basis of criteria in Annex II of Directive 90/219 and Commission classification guidelines.211 The directive creates a couple of exclusions. Its notification requirements do not apply to transport of GMMs by road, rail, inland, waterway, sea, or air.212 Also, none of the directive's provisions is to apply to "the storage, transport, destruction or disposal or use"213 of GMMs that have been placed on the market "under Community legislation, which [29 ELR 10533] includes a specific risk assessment similar to that provided in this Directive."214 Risk Assessment and Safety Measures GMM users must "carry out a prior assessment of the contained uses as regards the risks to human health and the environment that they may incur."215 In conducting such an assessment, the user is to "take due account"216 of characteristics of the donor, recipient, or parental organisms,217 characteristics of the modified microorganism,218 health considerations,219 and environmental considerations.220 The user must keep a record of the risk assessment and make it available to the competent authority on request.221 Further, GMM users are to follow principles of good microbiological practice and principles of good occupational safety and hygiene.222 For GMMs classified in Group 2, specific containment measures must be taken to ensure a higher level of safety.223 The directive's notification requirements may be triggered by the first use of installations and the first use of GMMs. [] Installations. A prior notification to the national authority is required when an installation is to be used for the first time for operations involving the contained use of GMMs.224 This notification must include, in addition to a summary of the risk assessment,225 information regarding personnel, including their qualifications and training, a description of the installation, and the likely scale of the operation.226 Depending on the classification of the GMMs, either a "negative vetting" or a "positive vetting" procedure applies to first-time use of installations. As to operations involving the first time use of a GMM, if (1) the GMMs are classified to Group I and are to be used in Type B operations, or (2) the GMMs belong to Group II and are to be used in Type A installations, a negative vetting procedure applies and the use may proceed after 60 days from submission of the notification, unless national authorities object.227 For the contained use of Group II GMMs in Type B operations, on the other hand, a positive vetting procedure applies and use may not proceed until approved by national authorities. For these perceived higher risk activities, authorities must communicate their decision in writing at the latest 90 days after submission of the notification.228 [] GMMs. A separate notification must be submitted before the first use of any GMMs. Depending on the type of operation and classification of the GMMs, the data to be included in the notification is more or less extensive.229 [] Group I GMM/Type A Installation. The authorities need not be notified of this use. Users are required simply to keep records of the work carried out and make them available to the competent authority on request.230 [] Group I GMM/Type B Installation. Users must submit a notification containing the following information: * the date of submission of the notification for the first use of the installation; * the parental micro-organism(s) used and the host-vector systems used; * the source and the intended function of the genetic material; * the GMMs identity and characteristics; * the purpose of the contained use and expected results; * the culture volumes to be used; and * a risk assessment summary.231 Once the notification has been submitted, the contained use may proceed after 60 days (or earlier with the competent authority's agreement) in the absence of any indication to the contrary.232 [] Group II GMM/Type A Installation. Users must submit a notification including the information required [29 ELR 10534] for users of Group I, Type B as listed above, plus the following information: * a description of the sections of the installation and methods for handling the GMMs; * a description of predominant meteorological conditions and of potential sources of danger; * a description of protective and supervisory measures to be applied throughout the contained use; and * the containment category allocated, as well as waste treatment and safety measures.233 The contained use may proceed 60 days after submission of notification (or earlier with the competent authority's agreement) in the absence of any indication to the contrary.234 [] Group II GMM/Type B Installation. Users must submit a notification containing the following: * information on the GMM; * information on personnel and training; * information on the installation; * information on waste management; * information on accident prevention and emergency response plans; and * the risk assessment.235 The contained use may not proceed without the consent of the competent authority. That authority must communicate its decision in writing within 90 days of the submission of the notification.236 If the authority deems that information provided in a notification is not in conformity with the directive, it may ask the user to provide further information or to modify the conditions of the proposed contained use.237 If the authority requests further information, the proposed contained use may not proceed until the authority has given its approval.238 The authority may also limit the time for which the contained use is permitted or may subject the use to other conditions.239 The directive imposes reporting obligations on users. It provides that the user must inform the authority "as soon as possible" and must modify the notification if the "user becomes aware of relevant new information or modifies the contained use in a way in which could have significant consequences for the risks posed by the contained use."240 The revised directive provides no guidance on the meaning of "significant" in this context. The directive also authorizes authorities to revisit notifications when they obtain new information ("if information subsequently becomes available to the competent authority which could have significant consequences for the risks posed by the contained use, the competent authority may require the user to modify the conditions of, or suspend or terminate the contained use").241 Emergency Planning and Accidents Authorities must ensure that before the start of an operation concerning the contained use of GMMs, some special precautions are taken. In particular, "where necessary," an emergency plan must be drawn up for the protection of human health and the environment outside the installation in the event of an accident, and the emergency services must be informed of potential hazards.242 In the event of an "accident," the user must immediately notify the competent authority and provide the following information: * the circumstances of the accident; * the identity and quantities of GMMs released; * information necessary to assess the accident's effects on human health and the environment; and * emergency measures taken.243 The term "accident" is defined as "any incident involving a significant and unintended release of [GMMs] in the course of their contained use which could present an immediate or delayed hazard to human health or the environment."244 No guidance is given on the meaning of "significant" or "hazard," thus leaving the definition of "accident" and the scope of the reporting obligation vague. The directive states that, "where a Member State considers it appropriate, it may provide that groups or the public shall be consulted on aspects of the proposed contained use."245 Thus, the directive itself does not require public consultation procedures, but member states are free to impose such requirements. The directive provides that the Commission and competent authorities "shall not divulge to third parties any confidential information notified or otherwise provided under this Directive and shall protect intellectual property rights relating [29 ELR 10535] to the data received."246 Users may indicate in notifications information they wish to keep confidential, but must explain how the disclosure of the information could harm their "competitive position."247 The competent authority decides which information will be kept confidential.248 Some information submitted with the notification is considered public and must "in no case" be kept confidential, including: (1) the description of the GMM, (2) the name and address of the notifier, (3) the location of use, (4) emergency plans, and (5) the evaluation of foreseeable effects, in particular any pathogenic and/or ecologically disruptive effects.249 However, the directive provides that when a notification is withdrawn, authorities must respect the confidentiality of the information supplied. Though the legislation is unclear, this confidentiality protection would presumably reach to information that otherwise would have to be made public, as long as the notification is withdrawn prior to the contained use. The revised Contained Use Directive, which will need to be implemented by member states by mid-2000, will substantially restructure notification and containment requirements. Much of the rest of the contained use legislation, which is described above, remains largely the same.250 Risk Assessment and Classification The revised directive requires member states to ensure that "all appropriate measures are taken to avoid adverse effects on human health and the environment which might arise from the contained use of GMMs."251 To this end, the revised directive requires that the "user"252 carry out "an assessment of the contained uses as regards the risks to human health and the environment that these contained uses may incur, using a minimum of elements of assessment and the procedure set out in Annex III, sections A and B."253 This assessment is to result in the "final classifications" of contained uses in one of the following four classes by applying the procedure set out in Annex III, which in turn results in assignment of containment levels: Class 1: activities of no or negligible risk-activities for which Level 1 containment is appropriate; Class 2: activities of low risk-activities for which Level 2 containment is appropriate; Class 3: activities of moderate risk-activities for which Level 3 containment is appropriate; and Class 4: activities of high risk-activities for which Level 4 containment is appropriate.254 The user is to keep a "record of the assessment" and make it available in an "appropriate form" to the authority as part of a notification or on request.255 The legislation does not indicate, however, how long the user must keep such records, thus implying an open-ended recordkeeping obligation. The revised directive states that the user shall apply (except to the extent that Annex IV, paragraph 2, allows other measures to be applied) the containment and protective measures set out in Annex IV corresponding to the contained use class.256 [] Premises First-Use Notification. Before premises are used for the first time for contained uses, the user must submit to the competent authorities a notification containing at least the information listed in Annex V, Part A.257 Specifically, the notification is to include the following information: * name of user(s), including those responsible for supervision and safety; * information on training and qualifications of persons responsible for supervision and safety; * details of any biological committees; * address and general description of premises; * description of work that will be done; * contained use classes; and * only for Class 1 contained uses, a risk assessment summary and waste management information.258 [] Class 1. Following such first-use notifications, subsequent Class 1 contained uses may proceed without further notification. However, the user is required to keep a record of the risk assessment.259 [] Class 2. For first and subsequent Class 2 contained uses in previously notified premises, a notification containing the information listed in Annex V, Part B must be submitted.260 That information must include the following: * date of submission of the premises notification; [29 ELR 10536] * recipient, donor, and/or parental micro-organism(s) and, where applicable, host-vector system(s); * source(s) and intended function(s) of genetic material(s) involved in the modification(s); * identity and characteristics of the GMM; * purpose of the contained use, including expected results; * approximate culture volumes; * description of containment and protective measures, and waste management information, including wastes to be generated, their treatment, final form, and destination; * risk assessment summary; and * information necessary for the competent authority to evaluate any emergency response plans.261 If the premises have been the subject of a previous notification to carry out a Class 2 or a higher class of contained use, and if any associated consent requirements have been satisfied, then the Class 2 contained use may proceed immediately following the new notification.262 If the premises have not been subjected to a Class 2 or higher notification, then the Class 2 contained use may, in the absence of indication to the contrary from the authority, proceed 45 days after submission of the notification—or earlier with the authority's agreement.263 [] Classes 3 and 4. For first and subsequent Class 3 or 4 contained uses in previously notified premises, a notification containing the information listed in Annex V, Part C shall be submitted.264 The following information is required for such notifications: * date of submission of the premises notification; * names of the persons responsible for supervision and safety, and training and qualifications information; * recipient and parental micro-organism(s); * host-vector system(s), where applicable; * source(s) and intended function(s) of genetic material(s) involved in modification(s); * identity and characteristics of the GMM; * culture volumes to be used; * description of containment and protective measures, including waste management information; * purpose of contained use and expected results; * description of installation; * information about accident prevention and emergency response plans, if any; * any specific hazards arising from the location of the installation; * preventive measures and procedures and plans for verifying effectiveness of containment measures; * a description of information provided to workers; * information necessary for the authority to evaluate any emergency response plans if required under the directive; and * the risk assessment.265 A Class 3 or higher contained use may not proceed without the authority's prior written consent.266 The competent authority may ask the user to provide further information or to modify conditions or classes of proposed contained uses. The authority may require that the contained use does not begin (or, if in progess, is suspended) until the authority has given its approval on the basis of the further information obtained or of the modified contained use conditions. The authority may also limit the time for which the contained use should be permitted or may subject the contained uses to conditions.267 Emergency Planning and Accidents The revised directive imposes emergency planning requirements. It requires that an emergency plan must be prepared for contained uses where "failure" of containment measures could lead to "serious danger, whether immediate or delayed, to humans outside the premises and/or to the environment, except where such an emergency plan has been drawn up under other Community legislation."268 Where such emergency plans are required, they must be prepared before the use begins. The revised directive requires that information on emergency plans must be supplied to "bodies and authorities liable to be affected by the accident."269 The information shall also be made "publicly available."270 The revised directive requires that, in the event of an "accident," the user must inform the competent authority "immediately" and provide the following information: * circumstances of the accident; * identity and quantities of the GMMs; * information necessary to assess effects on the health of the general population and the environment; and * measures taken.271 On being notified of an accident, the national government is to ensure that any measures "necessary" are taken and is to immediately alert any member states that could be "affected by the accident."272 The revised directive provides that the Commission, working through the technical adaption committee, may revise the following: * Annex II, Parts A (genetic modification techniques/methods excluded from the directive) and C (specific GMMs excluded from the directive); and * Annexes III (risk assessment procedures), IV (containment/protective measures), and V (notification information).273 The revised directive also provides that before December 5, 2000, Annex II, Part B (criteria for exclusion of GMMs from the directive via listing in Annex II, Part C) shall be adopted by the Council acting by qualified majority on a proposal from the Commission.274 Directive 90/220 regulates deliberate releases into the environment of GMOs and the placing on the market of products containing or consisting of GMOs.275 GMO is defined, much like GMM, as "an organism in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination."276 The term "organism" is defined as "any biological entity capable of replication or of transferring genetic material."277 In addition to plants and animals, this definition covers microorganisms including parasites, bacteria, and viruses, and it also covers human beings. "Deliberate release" is defined as "any intentional introduction into the environment of a GMO or a combination of GMOs without provisions for containment such as physical barriers together with chemical and/or biological barriers used to limit their contact with the general population and the environment."278 Placing on the market means "supplying or making available to third parties."279 There is an important difference between the procedure governing the marketing of GMOs and the procedures for experimental releases of GMOs and contained use of GMMs. Under the Contained Use Directive and, with respect to research releases under the Deliberate Release Directive, consent from the national authority, if required, suffices. By contrast, in the case of the marketing of GMOs, the Deliberate Release Directive effectively allows each national authority to initiate a Regulatory Committee procedure at the Community level.280 These diverging procedures reflect the fact that contained uses and experimental releases will likely have effects only in the country in which that use occurs, while marketing of GMOs could have effects in other countries as well. Any person who intends to make a deliberate release of GMOs into the environment or to place products containing GMOs on the market, must submit a notification to the competent authority of the member state in which the release will first occur.281 However, the procedures and requirements differ depending on whether the releases are: (1) research and development, or other noncommercial, releases, or (2) marketing releases. Research and Development Releases [] Notification. With regard to notifications concerning deliberate releases for research and development and purposes other than marketing, the notification must include a technical dossier and a risk assessment.282 The technical dossier must include information necessary for "evaluating the foreseeable risks" and include, in particular, information on the following: * personnel and training; * the GMOs; * the conditions of release and the receiving environment; * inter-actions between the GMOs and the environment; and * monitoring, control, waste treatment, and emergency plans.283 As for the risk assessment, it must be a "statement evaluating the impacts and risks posed by the GMO(s) to human health or the environment from the uses envisaged."284 The precise contents of the notifications are specified in considerable detail in the recently amended Annex II (Part A [29 ELR 10538] of the Annex applies to releases of GMOs other than higher plants, and Part B applies to releases of modified higher plants). Data on any prior releases by the notifier of the same GMO, occurring within or outside the Community, must also be submitted.285 The directive allows the notifier to refer also to data from prior notifications submitted by others, provided that the prior notifiers have consented in writing.286 Multiple releases or a release involving a combination of GMOs may, depending on national law, be covered by one notification.287 [] Vetting. The national authority concerned handles the vetting of research and development and other non-commercial releases. Other member states receive a summary of the filing and may comment, but they have no decisionmaking role. The national authority concerned is to assess the risks posed by the release and approve or reject the application. The authority is then to respond in writing within 90 days of receipt of a notification either that: (1) the authority "is satisfied that the notification is in compliance with this Directive and that the release may proceed, [or that (2)] the release does not fulfil the conditions of this Directive and the notification is therefore rejected."288 The deliberate release may proceed only after the authority has given its written consent289 and must be in accordance with any conditions prescribed in the approval. [] Public Consultation. As with the contained use rules, the Deliberate Release Directive states that member states, where they consider it "appropriate," may provide that "groups or the public … be consulted on any aspect of the proposed deliberate release."290 Some member states (e.g., Ireland and the U.K.) require experimental release notifiers to run advertisements in newspapers indicating the GMOs they intend to release, the purpose of the release, and the location. Private parties are then allowed to make representations to authorities on the prudence of allowing the experimental releases. [] Reporting. The directive creates a potentially expansive obligation on notifiers to modify notifications and conditions of release in the event of new information. More specifically, in the event of "any modification of the deliberate release of GMOs … which could have consequences with regard to the risks for human health or the environment," or "if new information has become available on such risks," the notifier must "immediately": (1) revise measures specified in the notification, (2) inform the competent authority in advance of any modification or as soon as the new information is available, and (3) take the measures "necessary" to protect human health and the environment.291 A literal (and implausible) reading of this provision would require notifiers to inform officials of each and every evolution of scientific knowledge regarding the risks related to a GMO, no matter how insignificant, even if the information implies lower risks than previously foreseen. As the obligation refers broadly to "new information," without possessive or qualitative qualifiers, arguably anything on the subject of the GMOs' risks published by any source, however dubious,would require a notification. Further, as this reporting obligation is temporally open-ended, it would arguably require reporting of new information even well after a release has been terminated. In addition to these expansive obligations, the directive creates a specific post-release reporting obligation. That is, the notifier is to report to the authority after the release on the "result of the release in respect of any risk to human health or the environment, with particular reference to any kind of product that the notifier intends to notify at a later stage."292 [] Notification. The placing on the market of products containing GMOs requires more extensive notification and prior consent procedures. Such consent, which may include conditions, may be granted only if either a written consent has previously been given with respect to research and development, or if a risk analysis has been carried out in accordance with the directive.293 In addition, the product must comply with the EC product legislation and with the Deliberate Release Directive's environmental risk assessment rules.294 The notification must include an extended risk assessment reflecting the "diversity of sites of use of the product,"295 including information on data and results from prior experimental releases. Annex II of the directive provides further detail on this part of the notification. The notification must also set forth proposals for conditions for placing the product on the market, including "specific conditions of use and handling and a proposal for labeling and packaging …."296 Annex III of the directive provides further detail on this part of the notification. The notifier must include data on any prior releases by the notifier of the same GMOs, occurring within or outside the Community.297 The directive allows the notifier to refer also to data from prior notifications submitted by others, provided that the prior notifiers have consented in writing.298 Further, "each new product which, containing or consisting of the same GMO or combination of GMOs, is intended for a different use, shall be notified separately."299 If, however, a notifier believes that the marketing and use of a product [29 ELR 10539] poses no risk, he may request an exemption with respect to certain items of the notification.300 [] Vetting. As for vetting, a marketing release triggers a centralized procedure in which decisionmaking is by the member states on the basis of qualified majority voting.301 Within 90 days of receipt of a notification (excluding periods during which the authority is awaiting information requested from the notifier), the national authority may either reject the proposed release or forward a summary of the notification302 to the Commission with a suggestion for a favorable opinion.303 On receipt of the notification, the Commission forwards the notification to other member states.304 If none objects within 60 days of distribution, the originating state may give its written consent to the release of the GMOs.305 If, however, another member state objects ("the reasons must be stated"), and no agreement can be reached, the national authority has no decisionmaking power.306 The Commission and a committee of national representatives, the Regulatory Committee, are then to rule. If no agreement can be reached between the Commission and the committee acting by qualified majority voting, the Commission may submit a proposal to the Council. The Council must decide within three months by qualified majority whether or not to approve the proposed release.307 If the Council fails to act within the three months, the Commission may adopt its proposal regarding the release.308 Once a decision has been made at the Community level, the originating state issues that decision. A product containing GMOs that has been properly authorized under the directive may be used anywhere in the Community, subject to the conditions specified by the consent.309 A member state may not prohibit, restrict, or impede the deliberate release of the GMO in that product if the consent's conditions are respected.310 It may, however, "provisionally" restrict or prohibit the use or sale of that product on its territory if it has "justifiable reasons" to consider that the product in question "constitutes a risk to human health or the environment."311 If a member state chooses to do so, it must immediately inform the Commission and other member states of its decision, providing its reasons.312 The Regulatory Committee, following the procedure described above, is then to make "a decision … on the matter" within three months.313 [] Labeling. A marketing notification must include a labeling proposal, which must cover information specified in the directive's Annex III as follows: * the name of the product and the names of GMOs contained therein; * the name of the manufacturer or distributor and his or her address in the Community; * "specificity of the product," with exact conditions of use including, when appropriate,the type of environment and/or the geographical area(s) of the Community for which the product is suited; and * the type of expected use—industry, agriculture, and skilled trades, or consumer use by the public at large.314 In its decision approving the release, the authority is to spell out the precise labeling requirements.315 The labeling of GMO products under Directive 90/220 has been the subject of controversy. Some member states have objected to the marketing of products whose labeling did not indicate that it was genetically modified. In 1997, through the Regulatory Committee procedure, the Commission amended the Annex III labeling requirements.316 Under the 1997 rules, any person putting a GMO product on the market must provide a specific label for the GMO. The label, or an accompanying document, must indicate that the product contains or consists of GMOs. With regard to GMO-containing products to be placed on the market in mixtures with non GMO-containing products, it is sufficient that the label refer to the possibility of GMOs being present. [] Reporting. As under the research and development release procedures discussed above, the directive creates an expansive obligation on marketing release notifiers to modify notifications and conditions of release in the event of new information, even if the information comes to light after a release. More specifically, "if new information has become available with regard to risks of the product to human health or the environment,"317 the notifier must "immediately" (1) revise the measures specified in the notification, (2) inform the competent authority, and (3) take the measures "necessary" to protect human health and the environment.318 As discussed above, a strict reading of this provision suggests that notifiers must inform officials of health and environmental risk information, no matter what the source, even if the information implies lower risks than previously foreseen. Also, as this reporting obligation applies after issuance of a consent, it would arguably require [29 ELR 10540] reporting of new information even well after a release has been terminated. As with the original Contained Use Directive, the Deliberate Release Directive provides that the Commission and authorities "shall not divulge to third parties any confidential information notified or otherwise provided under this Directive and shall protect intellectual property rights relating to the data received."319 Notifiers may indicate in notifications information they wish to keep confidential, but they must explain how the disclosure of the information could harm their "competitive position."320 The competent authority decides which information will be kept confidential.321 Some information submitted with the notification is considered public and must "in no case" be kept confidential, including: (1) the description of the GMOs, (2) the name and address of the notifier, (3) the purpose and location of release, (4) the methods and plans for monitoring the GMOs and for emergency response, and (5) the "evaluation of foreseeable effects, in particular any pathogenic and/or ecologically disruptive effects."322 The directive also provides that when a notification is withdrawn, authorities must respect confidentiality of information supplied.323 The Commission has in many cases sought to authorize GMO marketing releases.324 Some Commission proposals have been opposed by member states, with the result of the Commission authorizing marketing releases over national objections.325 A Commission Decision of January 23, 1997, authorizing marketing of genetically modified maize was followed by bans imposed by Austria, Italy, and Luxembourg.326 Following the opinions of three scientific committees, the Commission proposed decisions requiring Austria, Italy, and Luxembourg to withdraw their bans on genetically modified maize. The Commission's proposal was referred to the Regulatory Committee in January of 1998. The Committee, which has to adopt a position by qualified majority to approve the proposal, was unable to reach a decision.327 The matter was referred to the Council, which failed to act within the requisite three months.328 As of early March 1999, the Commission had not, however, taken further measures, presumably due to political sensitivities at stake. In its decisions authorizing the deliberate release of GMOs under Directive 90/220, the Commission has consistently found that any risks arising from such GMOs were entirely acceptable. In a number of cases, the Commission concluded that any potential risks for human health and the environment "are not expected to be significant."329 In another case, the Commission found that any potential risks were "no different from those presented by" another type of use of the same product.330 Having concluded that the risk of establishment was low, in yet another case, the Commission went on to state that the risk of transfer "could be controlled by existing management strategies."331 In most decisions, however, the Commission has employed a negative justification to the effect that "there is no reason to believe that there will be any adverse effects on human health and the environment."332 Proposed Amendments In February 1998, the Commission submitted a proposal for amendments to Directive 90/220.333 The proposal, prompted by the row over Novartis' maize, was discussed by the European Parliament in February 1999.334 The Novartis' maize case is thought to underscore the necessity of modifying the decisionmaking process. Under the current system, a qualified majority, in the Council in favor of or against a Commission proposal for authorization, is required. If there is no qualified majority in the Council, the final decisionmaking power rests with the Commission. The proposed amendments would change the decisionmaking procedure to a so-called IIIb Committee Procedure, which would mean that the Council could reject a Commission proposal by a simple majority.335 This would in effect increase the influence of individual member states in the decisionmaking process, since the opposition of fewer member states would be required to block a Commission proposal. The proposed amendments would also provide for a more flexible and tailored administrative procedure for experimental releases of GMOs. There would be a simplified procedure for Category I releases, which are defined as releases for which there is knowledge of safety and a standard. The full procedure would apply to Category II releases, which would include all other releases.336 As to Category I releases, the time limit within which authorities would have to make a decision would be reduced from 90 to 30 days, and the file would not need to be circulated to other member states and the Commission.337 Instead, every year, each member state would submit a list with the releases approved under this simplified procedure. The procedure for placing products on the market would also be simplified. In contrast to current arrangements, all member states would be involved in the procedure from the beginning. The period for submitting comments or raising objections would be reduced from 60 to 30 days.338 The new rules would also provide a simplified procedure for the renewal of consents and for cases where specific criteria and information requirements on the basis of safety experience have been established.339 The proposal further sets forth a procedure for authorizations for multistate releases.340 To promote greater uniformity and consistency in decisionmaking, the proposal includes common principles for risk assessment.341 These principles deal with the following: * identification of any hazardous characteristics of GMOs; * assessment of consequences of the hazard; * the likelihood of the hazard; * estimation of risk posed by the identified hazard; * application of management strategies for risks arising from GMOs; and * determination of the overall risk of adverse effects.342 These principles would apply to all releases, both experimental and placing on the market. Lastly, the proposal would provide more detailed labeling guidelines. In addition to labeling information currently required, the notifier would have to include in a notification a proposal for "mandatory labeling" that (1) "'this product contains GMOs,' either on the label or in accompanying documentation, whenever there is evidence of the presence of GMOs in the product,"343 or (2) "'this product may contain GMOs,' where the presence of GMOs in a product cannot be excluded but there is no evidence of any presence of GMOs."344 There is, at present, no Community legislation dealing specifically with liability for environmental damage.345 The Commission has been working for about a decade on proposals for environmental liability legislation—first for damage caused by waste, then for environmental damage in general. This section discusses the content and the status of the Commission's proposals. It also outlines the main principles of the 1993 Convention on Civil Liability for Damage Resulting From Activities Dangerous to the Environment adopted by the Council of Europe—another Europe-wide international organization, counting all 15 EC states as members. In 1989, the Commission adopted a proposal for a Directive on Civil Liability for Waste.346 According to the proposal, the producer of waste would be liable under civil law for the damage and impairment of the environment caused by the waste, irrespective of fault on his or her part.347 The "producer of waste" is defined as "any person who, in the course of a commercial or industrial activity, produces waste and/or anyone who carries out pre-processing, mixing or other operations resulting in a change in the nature or composition of this waste."348 A "producer of waste" would also [29 ELR 10542] include a person who imports waste into the Community and a person responsible for the installation to which the waste has been lawfully transferred. If the actual producer cannot be identified, the person with "actual control" of the waste at the moment when the damaging incident occurs would be liable. The proposal would impose strict (no-fault) liability. Defenses would be limited to force majeure, intentional acts, or omissions of third parties and the applicable statute of limitations in the proposed directive. The directive would not apply "to damage or impairment of the environment arising from an incident which occurred before the date on which [the directive's] provisions are implemented."349 Arguably, this would mean that liability would not be retroactive. However, a broad reading of the term "incident" could include contamination a long time after waste was originally disposed of, such as in the case of continued leaching.350 In 1991, the Commission also formally proposed a directive on landfill waste.351 Pursuant to the proposal, the operator of a landfill would be "liable under civil law for the damage and impairment of the environment caused by the landfilled waste, irrespective of fault on his or her part."352 The Council never discussed the Commission's proposal for a Civil Liability for Waste Directive.353 The proposed Landfill of Waste Directive has been significantly amended since the early 1990s, and the civil liability provision has been removed from the current proposal. Meanwhile, the Council asked the Commission to consider a general environmental liability system. In 1996, the Commission decided to abandon its efforts in the waste sector alone. In May 1993, in response to the Council's call for general Community environmental liability legislation, the Commission published a Green Paper on Environmental Liability.354 The Green Paper discusses some of the concepts on which a Community environmental liability system could be based. The Green Paper discusses, inter alia, the merits of fault and strict liability, different solutions to multiple party liability, the problems arising with historic pollution, and the possibility of creating joint compensation mechanisms to remedy environmental damage. In 1994, the European Parliament adopted a resolution requesting the Commission to submit "a proposal for a directive on civil liability in respect of future environmental damage."355 By July 1999, the Commission had not adopted such a proposal for a directive on environmental liability. In January 1997, the Commission formally asked Directorate-General XI (DG XI) to draft a White Paper on environmental liability, presenting the options for a Community environmental liability regime. The DG is currently working on the White Paper. A draft of the White Paper, dated April 22, 1998, outlines the likely principles of the Commission's proposal for a directive on environmental liability.356 Liability would lie upon "the person who exercises the control of an activity by which the damage is caused"357 (i.e., the operator). If there are multiple liable parties, the proposal will probably impose a joint and several liability regime. A jointly and severally liable party would be liable for the whole damage unless he can prove he caused only part of the damage. The eventual proposal would impose a strict liability regime. A limited number of defenses would be tolerated—force majeure, contribution to the damage or consent by the plaintiff, and intervention by a third party. The draft White Paper states that when a public authority imposes a certain way of action which results in the damage, the operator could claim that the damage is caused by the intervention of a third party. However, permit compliance would not be an acceptable defense if the permit imposes inadequate conditions. A Community environmental liability regime would, in a first stage at least, cover only dangerous activities that are already regulated by Community legislation (i.e., activities involving discharges or emissions of hazardous substances into water or air, dangerous substances and preparations, waste, biotechnology, transport of dangerous substances, as well as facilities subject to the Integrated Pollution Prevention and Control (IPPC) and the revised Directive on Major Accident Hazards of Certain Industrial Activities (Seveso Directive)).358 In addition to dangerous activities, the eventual directive would also cover environmental damage to natural resources protected by Community legislation (e.g., areas designated under the Habitats Directive359 and the Wild Birds Directive,360 and possibly water bodies under the future Framework Directive on Water361 and natural resources under the Biodiversity Convention).362 The "damage to natural resources" approach (in contrast to the "dangerous activities" approach) could seriously broaden the scope of the directive and apply the Community liability regime to activities that, so far, are not covered at all by Community [29 ELR 10543] legislation (including activities in the private sphere). Moreover, the draft White Paper states that member states should be allowed to go further and to apply the directive to environmental damage other than damage to protected natural resources, even if the damage is not caused by a dangerous activity regulated by Community legislation. Damage to natural resources protected under the Habitats and Wild Birds Directive would be evaluated taking the restoration costs as a starting point. If restoration is technically not possible, the evaluation of the natural resources would be based on the cost of alternative solutions, aiming at the establishment of natural resources equivalent to the destroyed natural resource. For sites contaminated by dangerous activities regulated by Community legislation, the draft White Paper proposes a minimum harmonization of existing national cleanup standards and cleanup objectives. With respect to cleanup standards (determining if cleanup of a contaminated site is necessary) the directive would contain a qualitative criterion: does the contamination (possible) lead to a serious threat to man and the environment? However, over time, common quantitative criteria could also be developed. As to cleanup objectives (defining the quality of soil and water at the site to be restored) the draft White Paper contemplates the same (qualitative) criterion: the cleanup should aim at the removal of any serious threat to man and environment. Thresholds would be set applying principles based on best available technology not entailing excessive costs (BATNEEC). The objective would be to render the soil fit for "actual and plausible future use." An environmental liability directive would probably deal only with "prospective" environmental damage. Only damage that occurs after the entry into force of the Community regime would be covered. It will be left to the member states to deal with pollution from the past. However, there may be significant transition problems, as it is not always possible, as a practical matter, to distinguish between existing and new contamination. According to the draft White Paper, once a plaintiff has made it "plausible" that the damage occurred after the entry into force of the Community regime, the burden of proof shifts to the operator, who, in order to escape liability, would have to show that the damage did not occur after that date. The Commission expected to publish the White Paper on environmental liability before the end of 1999. It will then probably take at least a year, if not much longer, to adopt a proposal for a directive. Once there is a formal proposal, the legislative procedure (involving the Council, the European Parliament, and other consultative bodies) will likely take at least two years. Council of Europe Civil Liability Convention In 1993, the Council of Europe adopted a Convention on Civil Liability for Damage Resulting From Dangerous Activities363 (also known as the Lugano Convention). The Convention is not part of Community legislation. So far, the Community has not acceded to the Convention. However, six member states (Finland, Greece, Italy, Luxembourg, Portugal, and the Netherlands) signed the Convention. The Convention could therefore have a direct impact on the law of those member states. Moreover, it may influence the further development of Community environmental liability legislation. The Convention creates a highly articulated liability regime under which "operators"364 of "dangerous activities" would be held strictly and jointly and severally liable for harms (personal injury, property damage, and environmental impairment) arising from "incidents" during their control of the activities.365 The term "dangerous activities" is defined broadly to include the "production, storage, handling or discharge"366 of substances having properties constituting "a significant risk for man, the environment or property."367 The Convention further provides that a substance that is "explosive, extremely flammable, highly flammable, [flammable,] very toxic, toxic, harmful, corrosive, irritant, sensitizing, carcinogenic, mutagenic, toxic for reproduction or dangerous to the environment within the meaning of [Community chemical legislation] shall in any event be deemed to constitute such a risk."368 As virtually all industrial facilities handle some chemicals bringing the facilities within the term "dangerous activities," the covered activities are multitudinous. The Convention applies prospectively (i.e., not creating liability for conduct prior to its implementation).369 However, it may have retroactive effects. Liability turns on the occurrence of an "incident," not the occurrence of the human act leading to an "incident." The term "incident" is defined as "any sudden occurrence or continuous occurrence or any series of occurrences having the same origin, which causes damage or creates a grave and imminent threat of causing damage."370 This definition could be interpreted to include, for example, continuous leaching of contamination to groundwater. If so, even if a human act leading to environmental contamination occurred years before implementation of the Convention, as long as an "incident" causing harm (e.g., leaching) occurs post implementation, liability under the Convention for the operator could arise. As the European Community's environmental legislation rapidly becomes more extensive and rigorous, it has become necessary to understand the Community legal order and Community environmental law in order to deal with environmental issues arising in the member states. Community law cannot be regarded independently of national law. However, unlike in the United States, where state environmental law may frequently be a reiteration and elaboration of independently applicable federal requirements, in the Community there are wide differences between the Community legislation (which usually does not apply directly to regulated parties) and the directly applicable national law. Nonetheless, Community law does sometimes impose obligations [29 ELR 10544] of real and practical importance independent of national law, and it is becoming an increasingly tight framework within which member states' systems must fit. Not only does Community law create minimum requirements for air, water, and waste policies, it imposes important restraints on the freedom of member states to regulate products. This growth of a comprehensive Community environmental policy framework appears certain to continue as the Community progresses toward the ideals of economic and political integration. 1. The Commission's DG XI has recently launched an effort to provide a strategy for existing and proposed product regulation. The Commission hired a consultant to prepare a study on this so-called Integrated Product Policy (IPP). The consultant's report is essentially descriptive—it reviews existing product regulation and then calls for a policy that addresses environmental issues from products' inception through to their final disposition. See ERNST & YOUNG AND THE SCIENCE POLICY RESEARCH UNIT, INTEGRATED PRODUCT POLICY: A STUDY ANALYZING NATIONAL AND INTERNATIONAL DEVELOPMENTS WITH REGARD TO INTEGRATED PRODUCT POLICY IN THE ENVIRONMENT FIELD AND PROVIDING ELEMENTS FOR AN EC POLICY IN THIS AREA (1998). DG XI has since held consultation meetings on IPP, and it seems likely that this new acronym will be relied on as a justification for further regulation. 2. Council Directive 84/450 of September 10, 1984 Relating to the Approximation of the Laws, Regulations and Administrative Provisions of the Member States Concerning Misleading Advertising, 1984 O.J. (L 250) 17, amended by Directive 97/55, 1997 O.J. (L 290) 18. 3. E.g., Council Directive 92/75 on the Indication by Labeling and Standard Product Information of the Consumption of Energy and Other Resources by Household Appliances, 1992 O.J. (L 297) 4; Council Regulation 2092/91 on Organic Production of Agricultural Products and Indications Referring Thereto on Agricultural Products and Foodstuffs, 1991 O.J. (L 198) 15. 4. Council Directive 84/450, supra note 2, art. 2, para. 2. In 1993, the Council adopted a resolution concerning, in particular, labeling. Council Resolution of April 5, 1993 on Future Action on the Labeling of Products in the Interest of the Consumer, 1993 O.J. (C 110) 1. The resolution requires labeling to be relevant and not misleading. A recent Commission report recommends harmonization at the EC level of existing national systems regulating "green credentials" of products to address the perceived proliferation of dubiously "green" products. EUROPEAN COMMISSION—DG XXIV, REPORT ON ACTION AGAINST DUBIOUS GREEN PRODUCTS (1999). 5. Council Directive 84/450, supra note 2, art. 3. 6. See supra note 3. 7. Id. art. 1(1). The Commission may decide, using the comitology procedure, to extend the labeling requirements to other types of house-hold appliances. Id. art. 1(2). 8. Id. art. 12. See, e.g., Commission Directive 97/17/EC of 16 April 1997 Implementing Council Directive 92/75/EC With Regard to Energy Labelling of Household Dishwashers, 1997 O.J. (L 118) 1, as amended by Commission Directive 99/9 of February 26, 1999, amending Directive 97/17 Implementing Council Directive 92/75 With Regard to Energy Labelling of Household Dishwashers, 1999 O.J. (L 56) 46; Commission Directive 98/11/EC of 27 January 1998 Implementing Council Directive 92/75/EEC With Regard to Energy Labeling of Household Lamps, 1998 O.J. (L 071) 1. Article 13 of Directive 92/75 provides that Directive 79/531 will be considered as implementing directive for electric ovens. 9. See supra note 3. 10. Id. art. 5. 11. Id. art. 6 and Annex I. 12. Commission Recommendation 98/480 of July 22, 1998 Concerning Good Environmental Practice for Household Laundry Detergents, 1998 O.J. (L 215) 73. 13. Id. art. 6. 14. Proposal for a Council Directive Relating to the Availability of Consumer Information on Fuel Economy in Respect of the Marketing of New Passenger Cars, 1998 O.J. (C 305) 2. 15. Id. art. 4. However, passenger cars for which the official fuel consumption and official specific carbon dioxide (CO2) emissions do not appear in the certificate of conformity are exempted. Id. 16. Council Directive 80/1268/EEC of 16 December 1980 on the Approximation of the Laws of the Member States Relating to the Fuel Consumption of Motor Vehicles, 1980 O.J. (L 375) 36. 17. Proposed Directive Relating to the Availability of Consumer Information on Fuel Economy in Respect of the Marketing of New Passenger Cars, supra note 14, Annex I. 18. Id. art. 5 and Annex II. 19. Id. art. 6. 20. Council Regulation 880/92 of March 23, 1992 Establishing a Community Eco-label Award Scheme, 1992 O.J. (L 99) 1. 21. Id. arts. 4(1) and 5(1). 22. The Commission has proposed the establishment of a European Eco-label Organization (EEO) that would set and update eco-label criteria and corresponding assessment and verification criteria. The EEO would be a private international association of member states' eco-label authorities. Proposal for a Council Regulation Establishing a Revised Community Eco-label Award Scheme, COM(96)603-EN, 1997 O.J. (C 114) 9. The Environment Council of June 24-25, 1999, reached a political agreement on the proposal on the basis of a Presidency compromise. The draft common position does not foresee the establishment of the EEO, but rather the creation by the Commission of an advisory European Union Ecolabeling Board (EUEB), composed of the competent bodies designated by the member states and of the Consultation Forum of interested parties. 23. Council Regulation 880/92, supra note 20, art. 5(4). Annex I of the regulation contains a number of environmental aspects the Commission has to take into consideration. These include waste relevance, soil pollution, water and air contamination, noise, energy consumption, consumption of natural resources, and effect on eco-systems. 24. Id. art. 5(5). 25. Commission Decision 95/365 of July 25, 1995 Establishing the Ecological Criteria for the Award of the Community Eco-label to Laundry Detergents, 1995 O.J. (L 217) 14; Commission Decision 95/533 of December 1, 1995 Establishing the Ecological Criteria for the Award of the Community Eco-label to Single-ended Light Bulbs, 1995 O.J. (L 302) 42; Commission Decision 96/304 of April 22, 1996 Establishing the Ecological Criteria for the Award of the Community Eco-label to Bed Linen and T-shirts, 1996 O.J. (L 116) 30; Commission Decision 96/337 of May 8, 1996 Establishing the Ecological Criteria for the Award of the Community Eco-label to Double-ended Light Bulbs, 1996 O.J. (L 128) 24; Commission Decision 96/461 of July 11, 1996 Establishing the Ecological Criteria for the Award of the Community Eco-label to Washing Machines, 1996 O.J. (L 191) 56; Commission Decision 96/467 of July 16, 1996 Establishing the Ecological Criteria for the Award of the Community Eco-label to Copying Paper, 1996 O.J. (L 192) 26; Commission Decision 96/703 of November 26, 1996 Establishing the Ecological Criteria for the Award of the Community Eco-label to Refrigerators, 1996 O.J. (L 323) 34; Commission Decision 98/483 Establishing the Ecological Criteria for the Award of the Community Eco-label to Dishwashers, 1998 O.J. (L 216) 12; Commission Decision 98/488 Establishing the Ecological Criteria for the Award of the Community Eco-label to Soil Improvers, 1998 O.J. (L 219) 39; Commission Decision 98/634 of October 2, 1998 Establishing the Ecological Criteria for the Award of the Community Eco-label to Bed Mattresses, 1998 O.J. (L 302) 31; Commission Decision 99/10 of December 18, 1998 Establishing the Ecological Criteria for the Award of the Community Eco-label to Indoor Paints and Varnishes, 1999 O.J. (L 5) 77. 26. Council Regulation 880/92, supra note 20, art. 10(1). 27. Infra note 127. 28. Infra note 128. 29. Council Regulation 880/92, supra note 20, art. 4(2). 30. Id. art. 10(3) and (4). 31. Proposal for a Council Regulation Establishing a Revised Community Eco-label Award Scheme, supra note 22. 32. For a discussion of the extension of "producer responsibility" to other product groups and of work at the OECD and national levels, see Rod Hunter, EU to Manufacturers: Take Back Old Products, NAT'L L.J., Dec. 22, 1997, at B8. For a discussion of potential trade issues, see Rod Hunter, EU Recycle Laws Could Spark Trade War, NAT'L L.J., Mar. 18, 1996, at A19. 33. European Parliament and Council Directive 94/62/EC on Packaging and Packaging Waste, 1994 O.J. (L 365) 10. 34. Id. art. 2(1). 35. Id. art. 3(1). 36. Id. art. 3(1)(a)-(c). 37. Id. art. 9. 38. Id. Annex II. 39. According to European Commission officials, no national standards on essential requirements for packaging have been communicated to the Commission and published. 40. European Parliament and Council Directive 94/62/EC, supra note 33, art. 11. 41. Id. art. 11(1). 42. Id. art. 11(3). The Commission adopted on February 8, 1999, a decision establishing the conditions for a derogation from directive heavy metals levels for plastic crates and plastic pallets, 1999 O.J. (L 56) 99. 43. COM(96) 191 final, 1996 O.J. (C 382) 10. The European Parliament adopted in September 1997 a Working Paper on the Proposed Directive on Marking of Packaging and on a Conformity Assessment Procedure for Packaging. At the Parliament's first discussion on the Commission's proposal on October 7, 1997, the Environment Committee voted to suspend consideration of the proposal until the Commission answers questions posed in the working paper. 44. Id. Annex III. 45. Commission Decision 97/129/EC of 28 January 1997 Establishing the Identification System for Packaging Materials Pursuant to European Parliament and Council Directive 94/62/EC on Packaging and Packaging Waste, 1997 O.J. (L 050) 28. 46. Id. pmbl. 47. European Parliament and Council Directive 94/62/EC on Packaging and Packaging Waste, supra note 33, art. 6. 48. Id. art. 7. 49. Id. 50. Council Directive 91/157 on Batteries and Accumulators Containing Certain Dangerous Substances, 1991 O.J. (L 78) 38, as adapted by Commission Directive 93/86 Adapting to Technical Progress Directive 91/157 on Batteries and Accumulators Containing Certain Dangerous Substances, 1993 O.J. (L 264) 51. 51. Id. art. 2. 52. Id. Annex I. 53. Commission Directive 98/101 Adapting to Technical Progress Council Directive 91/157 on Batteries and Accumulators Containing Certain Dangerous Substances, 1999 O.J. (L 1) 1. 54. Id. art. 1 and Annex I. 55. Council Directive 91/157, supra note 50, art. 3(1). 56. Id. art. 3. The directive provides that the paragraph imposing this ban, and the exemption, are to be inserted in Annex 1 to Directive 76/769 on the Approximation of the Laws, Regulations and Administrative Provisions of the Member States Relating to Restrictions on the Marketing and Use of Certain Dangerous Substances and Preparations, as amended, 1976 O.J. (L 262) 201. 57. Commission Directive 98/101, supra note 53, art. 1. 58. Id. 59. Council Directive 91/157, supra note 50, art. 4 (also stating that the Commission shall draw up, in accordance with the procedure referred to in Article 10 of the directive, the detailed arrangements for the marking system). 60. Commission Directive 93/86 of October 4, 1993 Adapting to Technical Progress Council Directive 91/157 on Batteries and Accumulators Containing Certain Dangerous Substances, 1993 O.J. (L 264) 51, arts. 2 and 3. 61. Id. art. 4. 62. Council Directive 91/157, supra note 50, art. 5. 63. Id. art. 5 and Annex II. 64. Id. 65. Id. art. 4. A "spent battery or accumulator" is defined in Article 2 as "a battery or accumulator which is not re-usable and is intended for recovery or disposal." "Collection" is defined in Article 2 as "the gathering, sorting and/or grouping together of spent batteries and accumulators." 66. Id. art. 7. The term "deposit system" is defined, in Article 2(f), as "a system under which the buyer, upon purchase of batteries or accumulators, pays the seller a sum of money which is refunded when the spent batteries or accumulators are returned." 67. Id. art. 10. 68. Proposal for a Council Directive on End of Life Vehicles, 1997 O.J. (C 337) 3. 69. Id. arts. 2 and 3. The directive states that it would apply to "any vehicle designated as category MI or NI defined in Annex II(A) to Directive 70/156/EEC and two or three wheel motor vehicles." Id. art. 2(1). 70. The European Parliament adopted the proposal in a first reading with amendments on February 11, 1999. Eur. Parl., Proposal for a Council Directive on End of Life Vehicles, Minutes of Feb. 11, 1999—Provisional Edition. 71. Id. art. 4(2). 72. Id. 73. Id. art. 4(1). 74. See infra section Reuse and Recovery. 75. Proposal for a Council Directive on End of Life Vehicles, supra note 68, art. 7(4). 76. Id. 77. Id. art. 8(1). Producers are also to provide "dismantling manuals" by December 31, 1999, that "identify, as far as it is needed by treatment facilities … , the different vehicle components and materials, and the location of all hazardous substances in the vehicles." Id. art. 8(3). 78. Id. art. 8(2). 79. Id. art. 2(3). 80. Id. arts. 5(4) and 13. 81. Id. art. 5(3). The several member states are to "mutually recognize and accept the certificates of destruction issued in other Member States." To this end, the Commission is to prescribe by June 30, 1999, pursuant to the technical committee procedure, "the minimum requirements for the certificate of destruction." Id. arts. 5(5) and 12(b). 82. Id. art. 6(2). The proposed directive's annex prescribes a number of conditions, so-called technical requirements, for sites for storage and/or treatment of end of life vehicles. The proposed directive would also authorize the Commission, working with the technical committee under Directive 75/442 on Waste, to modify (and expand) these requirements. Id. art. 12(a). 83. Id. art. 6(3)(a). 84. Id. 85. Id. art. 6(3)(b). 86. Id. art. 6(3)(c). 87. Id. art. 7(1). 88. Id. art. 7(2). Each of these targets is expressed as being for "all end of life vehicles." 89. Id. 90. Id. art. 9(1). 91. Id. art. 9(2). 92. Id. 93. European Commission, Directorate-General XI, Waste Unit, Second Draft Proposal for a Directive on Waste From Electrical and Electronic Equipment (July 27, 1998). The second draft of the directive adds to the proposal's environmental objectives the objective of "harmonising national measures concerning end-of-life electrical and electronic equipment in order to ensure the functioning of the internal market and to avoid obstacles to trade and distortion of competition within the Community." Id. art. 1. For an analysis of the first draft of the proposal, see Rod Hunter, Implications of European Commission Proposal for Electronics Take-Back Directive, 21 Int'l Env't Rep. (BNA) 703 (July 8, 1998). Just before printing of this Article, the Commission circulated a third draft of the electronics proposal. This draft is very similar to the second draft, discussed here, except that the recycled content requirement was removed because of trade law concerns. 94. Second Draft Proposal for a Directive on Waste From Electrical and Electronic Equipment, supra note 93, art. 2(1). 95. Id. 96. Id. 97. Id. art. 4(4). Commission staff, citing the "precautionary principle," have asserted that it is necessary to get these substances out of the environment. The Commission has made no showing that these substances, as used in electronics products, pose a threat to human health or the environment, nor tried to examine whether Europeans will be better off after imposition of the bans. In any event, even if the substances posed the threat that Commission officials intimate, one would have thought that the Commission's Chemicals Unit (as opposed to the Waste Unit) would be working on the matter, and that that unit would seek to regulate the placing on the market and use of those substances across the economy, not just in electrical and electronic equipment. 98. The currently listed exceptions from the ban include the following: mercury in compact fluorescent lamps not exceeding 4 milligrams (mg) per lamp; mercury in straight fluorescent lamps not exceeding 15 mg per lamp; mercury in lamps not specifically otherwise mentioned in the annex; mercury in thermometers used to perform specific analytical tests according to established standards; equipment for the calibration of platinum resistance thermometers using the triple point of mercury; lead as radiation protection; lead in glass cathode ray tubes, light bulbs and fluorescent tubes; halogenated flame retardants in those cases where the relevant fire safety standard can technically not be achieved through the use of other types of flame retardants. Id. Annex III. 99. Id. art. 15. 100. Id. art. 7(4). 101. Id. art. 4(1)-(2). 102. Id. art. 4(3). 103. Id. art. 9. 104. Id. art. 4(2)(b). 105. Id. 106. Id. art. 5(1). 107. Id. The term "waste from private households" is defined in Article 2(11) as "waste from private households, as well as commercial, industrial, institutional and other waste which, because of its nature and quantity, is similar to waste from private households." 108. Id. art. 5(4). 109. Id. art. 6(1). 110. Id. art. 6(2). 111. Id. 112. Id. art. 15. 113. Id. art. 6(6). 114. Id. art. 2(8). 115. Id. art. 7(1). 116. Declaration of Florian Ermacora, Waste Management Unit of DG XI, Environment, Industry Consultation Meeting Hosted by DG XI on Waste Policy (June 15, 1998). 117. See, e.g., Unplugging Electrical & Electronic Waste. The Findings of the Lothian and Edinburgh Environmental Partnership (LEEP) Collection Trial, February 1997; FIEE (Federation des Industries Electriques et Electroniques), Produits Electriques et Electroniques non Portables en Fin de Vie en Region Rhone-Alpes, Final Report, January 1997; Modeilversuch zur Sammlung, Demontage und Verwertung von Elektro- und Elektronikgeraeten (EAG) im Bezirk Weiz, Elektronikshrott Projekt Weiz, March 1996, Regional Government Styria, Austria. 118. Second Draft Proposal for a Directive on Waste From Electrical and Electronic Equipment, supra note 93, art. 8. 119. Id. art. 8(2). 120. Id. art. 8(3). 121. Id. art. 11. 122. Id. 123. Id. art. 15. 124. This listing is known as the European Inventory of Existing Commercial Chemical Substances or EINECS. See Commission Decision 81/437, 1981 O.J. (L 167) (explaining how the inventory is to be drawn up). 125. This listing is known as the European List of Notified Chemical Substances or ELINCS. See Commission Decision 85/71, 1985 O.J. (L 30) (explaining the contents of this list); Commission Communication, Publication of ELINCS, 1991 O.J. (C 139). 126. Commission Working Document, Report on Operation of Council Directive 67/548, Council Directive 88/379, Council Regulation 793/93, Council Directive 76/769, (SEC 1998) 1986 final, Brussels (Nov. 18, 1998). 127. Council Directive 67/548 on the Approximation of the Laws, Regulations and Administrative Provisions Relating to the Classification, Packaging, and Labelling of Dangerous Substances, 1967 O.J. (L 196) 1, as amended. See also Case 278/85, Commission v. Denmark, 1987 E.C.R. 4069, 4087 (ruling that with the directive the Community had laid down "an exhaustive set of rules governing the notification, classification, packaging and labelling of substances, both old and new, and that it has not left the Member States any scope to introduce other measures in their national legislation"). Also, the Community has legislation governing trade in dangerous chemicals into and out of the EC. Regulation 1734/88 Concerning Export From and Import Into the Community of Certain Dangerous Chemicals, 1988 O.J. (L 155) 2; Regulation 428/89 Concerning the Export of Certain Chemical Products, 1989 O.J. (L 50) 1. 128. Council Directive 88/379 on the Approximation of Laws, Regulations, and Administrative Provisions of the Member States Relating to the Classification, Packaging, and Labelling of Dangerous Preparations, 1988 O.J. (L 187) 14. 129. Council Directive 67/548, supra note 127, art. 2(1)(a), as amended. 130. Id. art. 2(b). 131. This is the definition set forth in a Commission document entitled "Reporting for the EINECS Inventory," EUROPEAN COMMISSION, REPORTING FOR THE EINECS INVENTORY, Appendix II (1982). "Articles" were not subject to reporting for the EINECS inventory, since they are not covered by the Dangerous Substances Directive. 132. Council Directive 67/548, supra note 127, art. 2(1)(d). 133. Id. art. 2(1)(c). 134. Id. 135. See infra section Testing and Notification Exemptions. 136. Each substance in a preparation must be tested separately. 137. Council Directive 67/548, supra note 127, art. 7(1). 138. Id. 139. Id. 140. Id. 141. Id. art. 7(1). The directive, Article 8, also provides "reduced" notification requirements for substances placed on the market in quantities less than one ton per year per manufacturer. 142. The Commission adopted on July 30, 1997, Commission Directive Adapting to Technical Progress for the Twenty-Second Time Directive 67/548 on Classification, Packaging and Labelling of Dangerous Substances. The new Commission directive amends Directive 67/548's Annexes I, III, V, and VI as indicated. * It amends the forward of Annex I, which contains the classification and labeling requirements and, where appropriate, the characterization of a list of dangerous substances, by including preparations containing these substances as harmful when they meet certain criteria as stated in Annex VI. * It adds enzymes to the organic substances classification in table B of the foreword to Annex I. * It adds to the list of phrases indicating the nature of risks attributed to dangerous substances and preparations the risk phrase R 65 "Harmful: may cause lung damage if swallowed." * It modifies Annex V of Directive 67/548, which sets methods for determining physicochemical properties, toxicity, and eco-toxicity of substances and preparations and incorporates, for example, a special procedure for testing oral acute toxicity of substances. * It amends Annex VI by introducing general criteria for the classification and labeling of new substances and preparations. Among other things, Annex V introduces new labeling requirements for special cases of substances and preparations, including gas containers intended for propane, butane or liquified petroleum gas, gaseous preparations and alloys, preparations containing polymers, and elastomers. 143. Council Directive 67/548, supra note 127, arts. 17 and 18, as amended. Notifiers who provide "full justification," may request that commercially sensitive information be kept secret from all persons other than the competent authorities and the Commission. Id. art. 19. 144. Id. art. 18(2) (also providing a mechanism for a member state to ask the Commission to adopt a measure requiring the notified member state to take some action). 145. Id. art. 31(1), as amended. 146. Id. 147. Id. 148. Id. (emphasis added). 149. Id. art. 32(2). 150. Council Directive 67/548, supra note 127, arts. 2(1)(h) and 13, as amended. 151. Id. art. 13(2). The last exemption for substances marketed for process-oriented research and development is limited to one year and is conditional on making a limited communication to member states where the substances will be used. 152. Id. For polymers, "the specific provisions concerning the technical dossiers contained in the notifications shall be laid down in Annex VII.D." Council Directive 67/548, supra note 127, art. 12, as amended. Annex VII D. was published in 1993 O.J.L 294/21. "Polymer" is defined in Council Directive 67/548, Article 2(c), as amended, as a substance consisting of molecules characterized by the sequence of one or more types of monomer units and comprising a simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant and consists of less than a simple weight majority of molecules of the same molecular weight. Such molecules must be distributed over a range of molecular weight wherein differences in the molecular weight are primarily attribuable to differences in the number of monomer units. In the context of this definition a monomer unit means the reacted form of a monomer in a polymer. 153. Council Directive 67/548, supra note 127, art. 15, as amended. 154. Id. art. 14. 155. Id. art. 4(1). 156. Id. art. 13(2). 157. Id. art. 23, Annex II, and Annex VI. The directive's Article 22 and Annex IX set out basic requirements for the packaging. 158. Id. art. 25(c). 159. Council Regulation 793/93 of 23 March 1993 on the Evaluation and Control of the Risk of Existing Substances, 1993 O.J. (L 84) 1. 160. Id. arts. 3 and 4. Annex II of the regulation lists about 70 existing substances not requiring reporting, as they are assumed not to present risks. This exemption list includes, e.g., Vitamin A, castor oil, limestone, and nitrogen. Id. art. 5 and Annex II. 161. Commission Working Document, Report on Operation of Council Directive 67/548, Council Directive 88/379, Council Regulation 793/93, Council Directive 76/769, supra note 126, at 6. 162. Council Regulation 793/93, supra note 159, art. 3. 163. Id. art. 4. 164. Id. art. 7(1). 165. Id. art. 7(2). 166. Id. 167. Commission Regulation 1179/94 Concerning the First List of Priority Substances as Foreseen Under Council Regulation 793/93, 1994 O.J. (131) 3; Commission Regulation 2268/95 Concerning the Second List of Priority Substances as Foreseen Under Council Regulation 793/93, 1995 O.J. (231) 18; Commission Regulation 143/97 Concerning the Third List of Priority Substances as Foreseen Under Council Regulation 793/93, 1997 O.J. (L 25) 13. 168. Commission Regulation 1488/94 Laying Down the Principles for the Assessment of Risks to Man and the Environment of Existing Substances in Accordance With Council Regulation 793/93, 1994 O.J. (L 161) 3. 169. Technical Guidance Document in Support of Commission Directive 93/67 on Risk Assessment for New Notified Substances and Commission Regulation 1488/94 on Risk Assessment for "Existing" Substances, 1996. 170. Commission Regulation 1488/94, supra note 168, arts. 2(2), 4, and 5. 171. Id. art. 6, Annex V, and Council Regulation 793/93, supra note 159, art. 10(3). 172. Council Regulation 793/93, supra note 159, art. 11. 173. Council Directive 88/379, supra note 128. The Commission proposed an amendment to this directive in 1996. Proposal for a European Parliament and Council Directive Concerning the Approximation of the Laws, Regulations and Administrative Provisions of the Member States Relating to the Classification, Packaging and Labelling of Dangerous Preparations, 1996 O.J. (C 283) 1. The Council adopted a common position on that proposal in September 1998. Council Common Position 54/98 With a View to Adoption of Directive 98/ …/EC of the European Parliament and Council Concerning the Approximation of Laws, Regulations and Administrative Provisions of the Member States Relating to the Classification, Packaging and Labelling of Dangerous Preparations, 1998 O.J. (C 360) 1. The European Parliament adopted second reading decision on the proposal on February 10, 1999, R4-0020/99 (Feb. 10, 1999). In remains for the Council to revisit the proposal a second time, before adoptions by the Parliament and Council together. 174. Id. recital 12. 175. Id. art. 3(3). 176. Id. 177. Id. art. 3(1) (also referring to the Labelling Guide Directive 67/548, as amended, Annex VI). 178. Council Directive 88/379, supra note 128, art. 7. 179. Id. art. 6. 180. Council Directive 67/548, supra note 127, and Council Directive 88/379, supra note 128. 181. Commission Directive 91/155 Defining and Laying Down the Detailed Arrangements for the System of Specific Information Relating to Dangerous Preparations in Implementation of Article 10 of Directive 88/379, 1991 O.J. (L 76) 35. 182. Id. art. 1(1) (emphasis added); but see id. art. 4 (stating that "implementing provisions for dangerous substances will be laid down later"). With respect to the actual contents of the SDS, the directive requires information on, among other things, the following: (1) the composition and ingredients; (2) hazards identification; (3) first-aid measures; (4) fire-fighting measures; (5) accidental release measures; (6) handling and storage; (7) exposure controls and personal protection; (8) physical and chemical properties; (9) stability and reactivity; (10) toxicological and ecological information; (11) transport and disposal considerations; and (12) regulatory information. Id. art. 3 (also providing that this information is to be compiled in accordance with the explanatory notes provided in the directive's annex). Also, the directive specifically allows member states to require as a precondition of the marketing of a dangerous substance or preparation in their territory that their official language(s) be used for the SDS. Id. art. 2. 183. Id. art. 1(2). 184. The section on toxicological information, according to the Commission guidelines, must include health effects from exposure to the substance or preparation, based on both experiences and conclusions from scientific experiments. More specifically, the SDS must include "information on the different routes of exposure (in-halation, ingestion, skin and eye contact), and describe the symptoms related to the physical, chemical and toxicological characteristics." It must also include "known delayed and immediate effects and chronic effects from short- and long-term exposure, for example sensitization, carcinogenicity, mutagenicity, and reproductive toxicity." 185. Commission Directive 91/155, supra note 181, Annex. 186. Id. Annex. 187. Id. art. 1(3). 188. Id. 189. Id. 190. Council Directive 88/379, supra note 128. 191. Council Directive 73/173 on the Approximation of Member States' Laws, Regulations and Administrative Provisions Relating to the Classification, Packaging and Labelling of Dangerous Preparations (Solvents), 1973 O.J. (L 189) 7, as amended. 192. Council Directive 77/728 on the Approximation of the Laws, Regulations and Administrative Provisions of the Member States Relating to the Classification, Packaging and Labelling of Paints, Varnishes, Printing Inks, Adhesives and Similar Products, 1977 O.J. (L 303) 23, as amended. 193. Council Directive 78/631 on the Approximation of the Laws of the Member States Relating to the Classification, Packaging and Labelling of Dangerous Preparations (Pesticides), 1978 O.J. (L 206) 13, as amended by Council Directive 81/187, 1981 O.J. (L 88) 29; Council Directive 84/291, 1984 O.J. (L 144) 1. 194. Council Directive 76/769 on the Approximation of the Laws, Regulations and Administrative Provisions of the Member States Relating to Restrictions on the Marketing and Use of Certain Dangerous Substances and Preparations, 1976 O.J. (L 262) 201, as amended by Council Directive 79/663, 1979 O.J. (L 197) 37; Council Directive 82/806, 1982 O.J. (L 339) 55; Council Directive 82/828, 1982 O.J. (L 350) 34; Council Directive 83/264, 1983 O.J. (L 147) 9; Council Directive 83/478, 1983 O.J. (L 263) 33; Council Directive 85/467, 1985 O.J. (L 269) 56; Council Directive 85/610, 1985 O.J. (L 375) 1; Council Directive 89/677, 1989 O.J. (L 398) 19; Council Directive 89/678, 1989 O.J. (L 398) 24; Council Directive 91/173, 1991 O.J. (L 85) 34. 195. Member states are required to take "all necessary measures" to ensure that the dangerous substances and preparations listed in the Annex are placed on the market or used only in accordance with the conditions specified in the Annex. Id. The restrictions, however, do not apply to marketing or use for research and development or analysis purposes. Id. art. 2. 196. Id. art. 2a. 197. Council Directive 90/219, 1990 O.J. (L 117) 1. 198. Council Directive 90/220, 1990 O.J. (L 117) 15. 199. Council Directive 90/679 on the Protection of Workers From Risks Related to Exposure to Biological Agents at Work (seventh individual Directive within the meaning of Article 16(1) of Directive 89/39), 1990 O.J. (L 374) 1. For an overview of EC occupational health and safety regulation, see Lucas Bergkamp & Rod Hunter, Occupational Health and Safety Framework: Current and Proposed European Union Legislation, World Food Reg. Rev. (BNA) (Mar. 1996) (Special Report). 200. Under Directive 94/55, 1994 O.J. (L 319) 7, GMOs are classified as infectious substances and, thus, are subject to the directive's placarding, packaging, labeling, and other requirements. 201. Regulation 258/97 Concerning Novel Foods and Novel Foods Ingredients, 1997 O.J. (L 43) 1. Pharmaceutical products derived from biotechnology are subject to the EC's pharmaceutical legislation. See T.P. Buono, Biotechnology-Derived Pharmaceuticals: Harmonizing Regional Regulations, 18 SUFFOLK TRANSNAT'L L. REV. 133 (1995). 202. As of April 24, 1998, 1,147 experimental releases had been notified to national authorities and 25 product notifications had been submitted, of which 16 had been approved and 9 were pending. Telephone Interview with the European Commission (Apr. 1998). 203. Council Directive 90/219, supra note 197. 204. Council Directive 98/81 Amending Directive 90/219 on the Contained Use of Genetically Modified Micro-organisms, 1998 O.J. (L 330) 13. 205. Council Directive 90/219, supra note 197, art. 2(c). 206. Id. art. 2(b). Genetic modification is the result of the use of the following techniques: * "recombinant DNA techniques using vector systems …"; * "techniques involving the direct introduction into a micro-organism of heritable material prepared outside the micro-organism including micro-injection, macro-injection, and micro-encapsulation"; and * "cell fusion or hybridization techniques where live cells with new combinations of heritable genetic material are formed through the fusion of two or more cells …." The directive excludes from its scope organisms obtained through the use of the following techniques: (1) techniques that "are not considered to result in genetic modification, on condition that they do not involve the use of recombinant-DNA molecules" or GMOs, including the following: * "in vitro fertilization"; * "conjugation, transduction, transformation, or any other natural process"; and * "polyploidy induction" (Id. Annex 1.A.2); and (2) techniques that result in genetic modification but are nevertheless excluded from the directive, on condition that they do not involve the use of GMMs as recipient or parental organisms, including the following: * "mutagenesis"; * "the construction and use of somatic animal hybridoma cells"; * "cell fusion (including protoplast fusion) of cells from plants that can be produced by traditional breeding methods"; and * "self-cloning of non-pathogenic naturally occurring micro-organisms which fulfil the criteria of Group I for recipient micro-organisms." Id. Annex 1.B (for Group I microorganisms, see supra footnote 200). 207. Council Directive 90/219, supra note 197, art. 2(7). 208. Id. art. 4(1). To be classified to Group I, the GMM must satisfy the criteria laid down in the directive's Annex II. These criteria refer to the recipient or parental organism, the vector/insert, and the GMM itself. The criteria require, for example, that the recipient contains no adventitious agents, that the vector is free from known harmful sequences, and that the GMM is nonpathogenic. GMMs that do not satisfy these Annex II criteria are deemed to pose higher risks. Commission Decision 91/448 sets additional, detailed guidelines for classification criteria. The guidelines introduce additional requirements for the classification of GMMs intended for Type B operations. Commission Decision 91/448 of July 29, 1991 Concerning the Guidelines for Classification Referred to in Article 4 of Directive 90/219, 1991 O.J. (L 239) 23, as amended by Commission Decision 96/134 of January 16, 1996, 1996 O.J. (L 31) 25. 209. "Small-scale" is not defined. By way of example, the directive refers to 10 liters of culture volume or less. Council Directive 90/219, supra note 197, art. 2(d). 210. Article 4 and Annex II of Council Directive 90/219 and Commission Decision 91/448 set out more detailed criteria for this classification scheme. 211. Commission Decision 91/448, supra note 208, art. 4. 212. Council Directive 90/219, supra note 197, art. 5. 213. Id. 214. Id. The directive does not define what is meant by "similar," thus leaving ambiguity as to which risk assessments under which legislation are adequate. 215. Id. art. 6(2). 216. Id. art. 6(3) and Annex III. 217. This requires taking into account the nature of pathogenicity and virulence, infectivity, toxicity, and vectors of disease transmission; significant involvement in environmental processes such as nitrogen fixation or pH regulation; the interaction with, and effects on, other organisms in the environment including likely competitive or symbiotic properties; and ability to form survival structures such as spores or sclerotia. 218. Such characteristics include the stability of the microorganism in terms of genetic traits, the frequency of mobilization of inserted vector and/or genetic transfer capability, and the rate and level of expression of the new genetic material and the method and sensitivity of measurement. 219. Health considerations include toxic or allergenic effects of non-viable organisms and/or their metabolic products, product hazards, and, if the microorganism is pathogenic to humans who are immunocompetent, diseases caused and mechanism of pathogenicity including invasiveness and virulence. 220. This requires taking into consideration factors affecting survival, multiplication, and dissemination of the GMM in the environment; available techniques for detection, identification, and monitoring of the modified microorganism; available techniques for detecting transfer of the new genetic material to other organisms; known and predicted habitats or the GMM; description of ecosystems to which the microorganism could be accidentally disseminated; anticipated mechanism and result of interaction between the GMM and the organisms or microorganisms that might be exposed in case of release into the environment; known or predicted effects on plants and animals such as pathogenicity, infectivity, toxicity, virulence, vector of pathogen, allergenicity, colonization; known or predicted involvement in biogeochemical processes; and availability of methods for decontamination of the area in case of release to the environment. 221. Council Directive 90/219, supra note 197, art. 6(4). 222. Id. art. 7 and Annex IV. 223. Id. Annex IV. 224. Id. art. 8(1). 225. Id. art. 6(4). 226. Id. art. 8 and Annex V. If a user becomes aware of relevant new information or modifies the contained use, national authorities must be informed and the notification amended. Id. art. 11(4). 227. Id. arts. 11(5)(a), 9(2), and 10(1). 228. Id. art. 11(4). 229. Id. arts. 9 and 10, and Annex V. 230. Id. art. 9(1). 231. Id. Annex V.B. 232. Id. art. 16(5)(a). 233. Id. Annex V.C. 234. Id. art. 11(5)(a). 235. Id. art. 10(2). The directive, Annex V.D., lays down detailed rules on the contents of this information. When the provision of some of the information is not possible for technical reasons, or if it does not appear necessary, the user must state the reasons. According to the directive, Annex V.D., the level of detail required by the authorities may vary depending on the nature and the scale of the proposed contained use. 236. Id. art. 11(5)(a). 237. Id. art. 11(3)(a). 238. Id. 239. Id. art. 11(3)(b). 240. Id. art. 12(1). 241. Id. art. 12(2). 242. Id. art. 14. 243. Id. art. 15(1). The directive provides for coordination between member states and with the Commission regarding the security of the installations for contained use of GMMs. Member states must make available, to other member states concerned, information on emergency plans for contained use. Id. art. 14(b). In the event of an accident, member states that could be affected must be immediately alerted. Id. art. 15(2). Member states must also inform the Commission, as soon as possible, of any accident. Id. art. 16(1)(b). 244. Id. art. 2(f). 245. Id. art. 13. 246. Id. art. 19(1). 247. Id. art. 19(2). 248. Id. art. 19(3). 249. Id. art. 19(4). 250. Council Directive 98/81 Amending Council Directive 90/219 supra note 204. The revised directive defines "contained use" as "any activity in which micro-organisms are generically modified or in which such GMMs are cultured, stored, transported, destroyed, disposed of or used in any other way, and for which specific containment measures are used to limit their contact with the general population and the environment." Council Directive 90/219, as amended, art. 2(c). The revised directive also modifies the GMM definition. See id. art. 2(b) and Annexes I and II. 251. Id. art. 5(1). 252. The "user" is a person "responsible for the contained use of GMMs." Id. art. 2(e). 253. Id. art 5(2). The revised directive states that this assessment "shall especially take into account the question of disposal of waste and effluents. Where appropriate, the necessary safety measures shall be implemented in order to protect human health and the environment." Id. art. 5(5). 254. Id. art. 5(3). The revised directive states that where there is "doubt as to which class is appropriate for the proposed contained use, the more stringent protective measures shall be applied unless sufficient evidence, in agreement with the competent authority, justifies the application of less stringent measures." Id. art. 5(4). 255. Id. art. 5(6). 256. Id. art. 6(1). The revised directive provides that the risk assessment and the containment and protective measures are to be reviewed periodically and reviewed right away if "there is reason to suspect that the assessment is no longer appropriate judged in the light of new scientific or technical knowledge." Id. art. 6(2). 257. Id. art. 7. 258. Id. Annex V.A. 259. Id. art. 8. 260. Id. art. 9(1). 261. Id. Annex V.B. 262. Id. art. 9(2). The applicant may, however, request a decision on a formal authorization from the competent authority. The decision must be made within a maximum of 45 days from the notification. Id. 263. Id. art. 9(3). 264. Id. art. 10(1). 265. Id. Annex V.C. 266. Id. art. 10(2). The authority is to communicate its decision to the notifier within 45 days of submission of the new notification in the case of premises that have been the subject of a previous notification for a Class 3 or higher contained use and where consent requirements have been satisfied for the same or higher class contained use. In other cases, the authority has 90 days from submission of the notification. Id. 267. Id. art. 11(3). For the purpose of calculating the periods referred to in Articles 9 and 10, any period of time during which the competent authority is awaiting any further information that it may have requested from the notifier, or is carrying out a public inquiry or consultation in accordance with Article 13, shall not be taken into account. Id. art. 11(4). 268. Id. art. 14. 269. Id. 270. Id. (also providing that "the Member States concerned shall at the same time make available to other Member States concerned, as a basis for all necessary consultation with the framework of their bilateral relations, the same information as that which is disseminated to their nationals"). 271. Id. art. 15(1). 272. Id. art. 15(2) (also requiring national officials to "collect, where possible, the information necessary for a full analysis of the accident and, where appropriate, make recommendations to avoid similar accidents in the future and to limit the effects thereof"). 273. Id. arts. 20 and 21. 274. Id. art. 20(a) (amendments to Annex II.B, are to be adopted by the same procedure). 275. Council Directive 90/220, supra note 198. 276. Id. art. 2(2) (also providing that within the terms of this definition (1) genetic modification occurs at least through use of techniques listed in Annex I.A.1, of the directive, and (2) techniques listed in Annex I.A.2, are not considered to result in genetic modification). The directive, in Article 3 and Annex I.B, also foresees the exclusion from the Directive of organisms produced from certain techniques that are deemed constitute genetic modifications. 277. Id. art. 2(1). 278. Council Directive 90/220, supra note 198, art. 2(3). 279. Id. art. 2(5). 280. Id. art. 13(3). 281. Id. art. 5(1). 282. Id. art. 5(1)-(2). The risk assessment rules have been the subject of criticism. Specifically, the criticism is directed at the lack of substantive criteria, an adequate description of the risks to be considered, and their relative weight. Food and pharmaceutical legislation provides much fuller definitions of the objectives of the risk assessments to be performed for such products, it is said. In addition, pleas are made for a much more differentiated approach commensurate with the specific risks involved in the release at issue. Indeed, not all releases pose the same level of risk and, consequently, merit the same level of administrative oversight. The current directive, however, does not provide for any risk classification nor for any differentiation of administrative requirements according to degree of risks. The proposed amendments, discussed infra at section Proposed Amendments, would address some of these issues. 283. Council Directive 90/220, supra note 198, art. 5(2)(a) and Annex II, as amended. 284. Id. art. 5(2)(b). 285. Id. art. 5(4). Note the importance of the definition of "notifier." A notifier is obliged to submit data from his prior releases, but not that from other notifiers. The term "notifier" is defined as "the person making the presentation [of the notification documents]." Id. art. 2(6) (emphasis added). This language could be construed to mean that a corporate entity making a notification might not need to report on data resulting from releases by a corporate entity with the same or overlapping shareholders. 286. Id. art. 5(4). 287. Id. art. 5(3). 288. Id. art. 6(2). For purposes of calculating the 90 days, periods during which the authority is awaiting further information requested from the notifier or carrying out a public inquiry or consultation are not taken into account. Id. art. 6(3). 289. Id. art. 6(4). 290. Id. art. 7. 291. Id. art. 5(6). 292. Id. art. 8. 293. Id. art. 10(1). 294. Id. 295. Id. 296. Id. 297. Id. art. 11(2). 298. Id. art. 11(3). 299. Id. art. 11(4). 300. Id. 301. These marketing release procedures do not apply to foods. The marketing of foods containing or derived from GMOs is governed by Regulation 258/97 Concerning Novel Foods and Novel Food Ingredients, supra note 201. 302. The format of this summary is regulated by Commission Decision 92/146 of February 11, 1992, 1993 O.J. (L 60) 19. 303. Council Directive 90/220, supra note 198, art. 13(2). 304. Id. art. 13(1). 305. Id. art. 13(5). 306. Id. arts. 13(3) and 21. 307. Id. art. 21. 308. Id. 309. Id. art. 13(5). 310. Id. art. 15. 311. Id. art. 16. 312. Id. art. 16(1). 313. Id. art. 16(2). 314. Id. art. 11(1) and Annex III. 315. Id. art. 11(1). These labeling requirements do not apply to food and food ingredients containing, consisting of, or derived from GMOs. These products are governed by specific labeling rules prescribed by the Novel Food Regulation. Regulation 258/97, supra note 201. These labeling requirements do not apply if a product already was consumed to a significant degree in the EC at the time the new rules came into force. 316. Commission Directive 97/35 of June 18, 1997 Adopting to Technical Progress for the Second Time Council Directive 90/220 on the Deliberate Release Into the Environment of Genetically Modified Organisms, 1997 O.J. (L 169) 72. 317. Council Directive 90/220, supra note 198, art. 5(6). 318. Id. art. 11(6) (see also Article 12(4) requiring competent authorities to inform other member states and the Commission of any such reported information). 319. Id. art. 19(1). 320. Id. art. 19(2). 321. Id. art. 19(3). 322. Id. art. 19(4). 323. Id. art. 19(5). 324. Commission Decision 93/572 of October 19, 1993 Raboral V-RG, 1993 O.J. (L 276) 16; Commission Decision 94/385 of June 8, 1994 Herbicide-Resistant Tobacco Variety ITB 1000 OX, 1994 O.J. (L 176) 23; Commission Decision 94/505 of July 18, 1994 Vaccine Nobi-Porvac Aujesky Live, 1994 O.J. (L 203) 22; Commission Decision 96/158 of February 6, 1996 Hybrid Herbicide-Tolerant Swede-Rape Seeds, 1996 O.J. (L 37) 30; Commission Decision 96/281 of April 3, 1996 Genetically Modified Soya Beans, 1996 O.J. (L 107) 10; Commission Decision 96/424 of May 20, 1996 Genetically Modified Male Sterile Chicory, 1996 O.J. (L 175) 25; Commission Decision 97/98 of January 23, 1997 Genetically Modified Maize, 1997 O.J. (L 31) 69; Commission Decision 97/392 of June 6, 1997 Genetically Modified Swede-Rape, 1997 O.J. (L 164) 38; and Commission Decision 97/549 of July 14, 1997 T102-test, 1997 O.J. (L 225) 34. 325. The Commission Decision of January 23, 1997, regarding genetically modified maize was opposed by 13 of the 15 member states. European Parliament Resolution on Genetically Modified Maize, April 8, 1997, 1997 O.J. (C 132) 2. 326. European Report No. 2249 (Sept. 10, 1997). 327. Id. No. 2308 (Apr. 18, 1998). 328. Id. No. 525 (June 23, 1998). 329. Commission Decision 93/572, Raboral V-RG, supra note 324 ("Whereas the Commission … has found that the potential risks for human health and the environment presented by the use of the genetically modified virus contained in Raboral V-RG … are not expected to be significant."). Commission Decision 94/385, Herbicide-Resistant Tobacco Variety ITB 1000 OX, supra note 324 ("Whereas the Commission … has found that the potential risks for human health and the environment presented by the placing on the market and cultivation of the Tobacco Variety … are not expected to be significant."). 330. Commission Decision 94/505, Vaccine Nobi-Porvac Aujesky Live, supra note 324 ("Whereas the Commission … has found that any potential risks for human health and the environment by placing on the market of Nobi-Porvac live for intra-dermal use are no different from those presented by the intra-muscular use of the same product."). 331. Commission Decision 96/158, Hybrid Herbicide-Tolerant Swede-Rape Seeds, supra note 324 ("Whereas it was concluded that the risk of establishment was low and that any spread or transfer of the herbicide tolerance gene could be controlled by existing management strategies."). 332. Commission Decision 96/281, Genetically Modified Soya Beans, supra note 324 ("Whereas … there is no reason to believe that there will be any adverse effects on human health and the environment."); Commission Decision 96/424, Genetically Modified Male Sterile Chicory, supra note 324: Whereas … there is no reason to believe that there will be any adverse effects (from the transfer of the bar gene to wild chicory populations given the fact that such transfer could only confer a competitive or selective advantage to wild populations if the herbicide glufosinate-ammonium were the only means of controlling these populations, which is not the case). Commission Decision 97/98, Genetically Modified Maize, supra note 324 ("The Commission reached the following conclusions: … there is no reasons [sic] to believe that the introduction of these genes into maize will have any adverse effects on human health or the environment."); Commission Decision 97/392, Genetically Modified Swede-Rape, supra note 324 ("Whereas … there is no reason to believe that there will be any adverse effects on human health and the environment from the introduction into swede-rape of the genes coding for phosphinotricin acetyl transferase and for neomycin phos-photransferase II.") Commission Decision 97/549, T102-test, supra note 324 ("Whereas … there is no reason to believe that there will be any adverse effects on human health or the environment from the introduction into Streptococcus thermophilus T102 of the gene coding for chloramphenicol-acetyl-transferase on the plasmid pMJ 763."). See also Commission Decisions of April 22, 1998, 98/292/EC (Zea mays L.Bt-11), 1998 O.J. (L 131) 28; 98/293/EC (Zea mays L.T25), 1998 O.J.(L 131) 30; and 98/294/EC (Zea mays L.MON810), 1998 O.J. (L 131) 32. 333. Proposal for a European Parliament and Council Directive Amending Directive 90/220/EEC on the Deliberate Release Into the Environment of Genetically Modified Organisms, 1998 O.J. (C 139) 1. On March 25, 1999, the Commission presented an amended proposal following debate in the European Parliament. 1999 O.J. (C 139). 334. See Report on the Proposal for a European Parliament and Council Directive Amending Directive 90/220/EEC on the Deliberate Release into the Environment of Genetically Modified Organisms. Committee on the Environment, Public Health and Consumer Protection, Rapporteur, David Bowe, PE 227.836fin, A4-0024/99 (Jan. 26, 1999). 335. Proposal for a European Parliament and Council Directive Amending Directive 90/220/EEC, supra note 333, art. 1(11) (revising art. 21). 336. Id. art. 1(1) (revising art. 6(2)). 337. Id. art. 1(2) (creating a new art. 6(a)). 338. Id. art. 1(3) (revising art. 13). 339. Id. art. 1(4) (creating a new art. 13(a)). 340. Id. art. 1(2) (creating a new art. 6(c)). 341. Id. art. 1(13) (revising Annex II). 342. Id. Annex II. 343. Id. Annex IV. 344. Id. art. 1(13) (revising Annex IV). 345. In 1985, the Council adopted a directive on product liability for defective products. Council Directive 85/374 on Product Liability, 1985 O.J. (L 210) 29. On the possible application of this directive to environmental damage situations, see LUDWIG KRAMER, FOCUS ON EUROPEAN ENVIRONMENTAL LAW (2d ed. 1997). 346. 1989 O.J. (C 251) 3. After consultation of the European Parliament, the Commission amended its proposal. 1991 O.J. (C 192) 6. See Turner T. Smith & Roszell D. Hunter. The Revised European Community Civil Liability for Damage From Waste Proposal, 21 ELR 10718 (Dec. 1991). 347. Proposed Directive, supra note 346, art. 3. 348. Id. 349. Id. art. 13. 350. See Smith & Hunter, supra note 346, at 10722-23; see also Peter Tester & Marc Whitehead, The EC Directive on Civil Liability for Damages Caused by Waste: Lessons From the "Superfund" Law, 1 EUR. ENVTL. L. REV. 26, 28 (1992). 351. See Commission Proposal for a Council Directive on the Landfill of Waste, 1991 O.J. (C 190) 1. 352. Id. art. 14. 353. See KRAMER, supra note 345 at 167. 354. Communication from the Commission to the Council and Parliament and the Economic and Social Committee: Green Paper on Remedying Environmental Damage, COM(93)47 final (May 14, 1993). 355. 1994 O.J. (C 128) 165. According to Article 138b(2) of the EC Treaty. "The European Parliament may, acting by a majority of its members, request the Commission to submit any appropriate proposal on matters on which it considers that a Community act is required for the purpose of implementing this Treaty." 356. Draft White Paper on Environmental Liability (Apr. 22, 1998), on file with authors. 357. However, the draft White Paper extends liability for environmental damage caused by waste. Apart from the operator controlling the waste at the time when the damage was caused, any other waste operator (including the waste producer) who has been involved in an illegal transaction of the waste would be liable, unless he can show that the transaction did not contribute to the damage. Id. 14-15. 358. In actuality, this would make the scope of the liability scheme very broad. The mere use of a dangerous substance or preparation in a professional activity (e.g., certain solvents in, say, a dairy farm) would make that a dangerous activity subject to liability, even if the use of those substances or preparations was not causally connected to the alleged damage. 359. Council Directive 92/43/EC of 21 May 1992 on the Conservation of Natural Habitats and of Wild Fauna and Flora, 1992 O.J. (L 206) 7. 360. Council Directive 79/409/EEC of 2 April 1979 on the Conservation of Wild Birds, 1979 O.J. (L 103) 1. 361. Proposal for a Council Directive Establishing a Framework for Community Action in the Field of Water Policy, 1997 O.J. (C 184) 20, as amended by Amended Proposal for a Council Directive Establishing a Framework for Community Action in the Field of Water Policy, 1998 O.J. (C 108) 94. 362. Rio de Janiero Convention on Biological Diversity of June 2, 1992. 363. Lugano Convention of June 21, 1993 on Civil Liability for Damage Resulting From Activities Dangerous to the Environment, Council of Europe European Treaties, E.T.S. No. 150. 364. "Operator" is defined as "the person who exercises the control of a dangerous activity." Id. art. 2(5). 365. Id. art. 6 (also providing that operators of sites for the "permanent deposit" of waste would be held strictly liable for harms which become known after the Convention's implementation). 366. Id. art. 2(2)(a). 367. Id. 368. Id. art. 2(2)(a) and Annex I.A. 369. Id. art. 2(11). 370. Id. 29 ELR 10515 | Environmental Law Reporter | copyright © 1999 | All rights reserved |