An Excerpt From: K&L Gates Global Government Solutions ® 2011: Mid-Year Outlook July 2011 Energy and Environment Proposed Changes to the EU Seveso II Directive The European Commission has proposed changes to the European Union’s (“EU”) “Seveso II” Directive, which regulates hazardous materials. These changes would have the effect of dramatically expanding the scope of the Directive and thus the responsibilities covered establishments. The Seveso accident happened in 1976 at a chemical plant in Seveso, Italy, manufacturing pesticides and herbicides. A dense vapor cloud containing dioxin, a poisonous and carcinogenic byproduct of an uncontrolled reaction, was released from a reactor. Although no immediate fatalities were reported, kilogram quantities of a substance lethal to man even in microgram doses were widely dispersed, which resulted in extensive contamination of land and vegetation, mass evacuation and as many as 2,000 cases of dioxin poisoning. dangerous substances are present in greater quantities than those which trigger this obligation is required to draw up (and review and keep updated) a safety report and internal emergency plans and to provide the relevant national authority with the necessary information to enable it to draw up external emergency plans. Finally, operators of such establishments must provide certain information to the authorities following a major accident. Seveso II applies to all establishments where specified quantities of dangerous substances are present as a raw material, product, by-product, residue, or intermediate. It also applies where the presence of dangerous substances is anticipated and where it is reasonable to suppose that dangerous substances may be generated in the event of accident. Seveso II also provides for inspections by national authorities and imposes a number of other obligations on national authorities. Member States may, and in some cases must, penalize failure to comply with certain of its requirements by prohibiting any use of the establishment concerned (which could involve shutting the plant). Once Seveso II applies, numerous potentially onerous obligations are triggered. Seveso II requires operators of establishments within its scope to take all measures necessary to prevent major accidents and to limit their consequences for humans and the environment. More specifically, the operator of such an establishment must notify the relevant national authority with prescribed information about the operator, the establishment, and the dangerous substances concerned and must draw up, document, and implement a majoraccident prevention policy. In addition, the operator of an establishment where Application of Seveso II is triggered by the presence of a given quantity of a “dangerous substance” at an establishment. For this purpose, “dangerous substance” means a substance or mixture which is expressly listed in Seveso II or which (essentially) has been classified as a dangerous substance or mixture in accordance with existing EU legislation on classification. In response, the EU adopted its first Seveso Directive (“Seveso I”) in 1982. Seveso I required EU Member States to ensure that certain manufacturers took the measures necessary to prevent major accidents and to limit their consequences for humans and the environment. In the light of accidents at the Union Carbide plant in Bhopal, India in 1984 (where a factory leak of methyl isocyanate caused more than 2,500 deaths) and at the Sandoz warehouse in Basel, Switzerland in 1986 (where contaminated fire-fighting water caused massive pollution of the Rhine and the death of half a million fish), Seveso I was amended so as to broaden its scope, in particular to include the storage of dangerous substances. Seveso II, which repealed and replaced Seveso I in 1996, imposed obligations directly on industry as well as on Member States. In addition, the scope was widened again and new requirements were added. Under that legislation it is possible for a substance or mixture to be classified as dangerous solely because it contains a constituent which is itself classified, even though the principal substance or The European Commission has proposed changes to the European Union “Seveso II” Directive, which regulates hazardous materials. 32 K&L Gates Global Government Solutions ® 2011 Mid-Year Outlook Energy and Environment In December 2010 the European Commission published a Proposal for a Seveso III Directive which would repeal and replace Seveso II with effect from June 1, 2015 (to coincide with the full implementation of the CLP Regulation). The principal change would be that Seveso III would reflect the new system for the classification of hazardous substances and mixtures laid down by the CLP Regulation. mixture has not itself been independently shown to be dangerous. This may result in an anomalous situation which can be illustrated by assuming that Substance A is classified as a dangerous substance for which the Seveso II quantity threshold is 100 tonnes and that Substance B contains 1 percent Substance A as an impurity and is itself classified as a result. Substance B will therefore be a “dangerous substance” within the scope of Seveso II. A facility will therefore be subject to Seveso II if 100 tonnes of Substance B are present even though only one tonne of Substance A is present. In contrast, a facility at which 99 tonnes of Substance A as such are present will not be subject to Seveso II. For various reasons, this anomaly has not previously given rise to significant problems in practice. However, recent and continuing changes to the EU legislation on classification mean that it is likely to be more of a problem in the future if the opportunity is not taken to rectify it. That legislation is currently being phased out and replaced by the new EU Regulation on Classification, Labelling and Packaging of Substances and Mixtures (“CLP Regulation”). This Regulation implements the UN Globally Harmonised System of classification and labelling of chemicals, which differs in some respects from the current EU legislation. Changes to the procedure for classification flowing from the CLP Regulation will mean that many more substances will be classified because of an impurity and many more mixtures will be classified because of a minor constituent. This greatly increases the risk that an establishment may become subject to Seveso III and its attendant obligations solely because a very small amount of a classified substance is contained in a compound substance or a mixture present at the establishment, while another establishment containing a much greater quantity of the classified substance remains outside the scope of Seveso III. Although Seveso III contains a derogation that might assist, this depends on the substance concerned being on a list compiled by the European Commission; it does not address the root of the anomaly. The proposed Seveso III Directive is currently proceeding through the EU legislative process. Some industry sectors are hoping to persuade the legislature to make amendments to remove the anomaly. It remains to be seen whether these efforts will bear fruit. Vanessa C. Edwards (London) vanessa.edwards@klgates.com Raminta Dereskeviciute (London) raminta.dereskeviciute@klgates.com K&L Gates Global Government Solutions ® 2011 Mid-Year Outlook 33 Anchorage Austin Beijing Berlin Boston Brussels Charlotte Chicago Dallas Doha Dubai Fort Worth Frankfurt Harrisburg Hong Kong London Los Angeles Miami Moscow Newark New York Orange County Palo Alto Paris Pittsburgh Portland Raleigh Research Triangle Park San Diego San Francisco Seattle Shanghai Singapore Spokane/Coeur d’Alene Taipei Tokyo Warsaw Washington, D.C. K&L Gates includes lawyers practicing out of 38 offices located in North America, Europe, Asia and the Middle East, and represents numerous GLOBAL 500, FORTUNE 100, and FTSE 100 corporations, in addition to growth and middle market companies, entrepreneurs, capital market participants and public sector entities. For more information about K&L Gates or its locations and registrations, visit www.klgates.com. 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