Author: Stephen C Beedle, principal process safety consultant, ABB Consulting The principal piece of European legislation relating to the prevention and control of major chemical accidents is the Seveso Directive, which emerged following an explosion in 1976 at a manufacturing facility near the Italian town of Meda. This incident gave rise to a release of a vapour cloud containing dioxin toxins that drifted across a heavily populated area and lead to ground contamination across a large area. The town of Seveso was located two kilometres downwind of the release point, so was in the direct path of the toxic cloud. Although several thousand people were exposed to the released chemicals, there were no human fatalities. The aftermath included the culling of animals to prevent the toxins from entering the food chain, removal and incineration of topsoil and the prohibition of farming over a wide area, which represented a significant economic impact. The Seveso Directive was adopted in 1982 as European Union Directive 82/501/EC. The purpose of the directive was to prevent major accidents at facilities that store, produce or use dangerous substances in sufficient quantities to constitute a serious health, safety or environmental risk. The Seveso Directive has been amended twice – firstly in 1987, in response to the Bhopal disaster in India, and again in 1988, following the Sandoz warehouse fire in Basel, Switzerland. The latter event led to extensive pollution of the River Rhine by chemicals including organophosphate pesticides. Consequently, in 1996, the original Directive 82/501/EC was replaced by Directive 96/82/EC, which became known as the Seveso II Directive, which extended the scope of the legislation and introduced new requirements. The scope of the Seveso II Directive was itself extended in 2003 by Directive 2003/105/EC following further industrial incidents including the fertilizer plant explosion at Toulouse, France in 2001. So, although it has been over 10 years since there has been a significant change to European Legislation governing the control of major chemical accidents, a major revision is due on 1 June 2015 when the Seveso II Directive is replaced by a new Directive 2012/18/EU, which is to be known as the Seveso III Directive. REASONS FOR THE SEVESO III DIRECTIVE [caption id="attachment_10599" align="alignright" width="646"] Toxic material alignment (image courtesy of the European Commission, DG ENV - Impact assessment study into possible options for adapting Annex 1 of the SEVESO II Directive into the GHS: Final Report (2010). Click to enlarge)[/caption] All dangerous substances are grouped in terms of their properties relating to, for example, fire, human-toxicity and eco-toxicity. The dangerous substances classification applied under Seveso II relates to the Dangerous Substances Directive (DSD) 67/548/EEC. The DSD is to be replaced by European Regulation 1272/2008 for the Globally Harmonised System for the classification, labelling and packaging of chemical substances and mixtures (CLP) on 1 June 2015. This means that from this date the Seveso II Directive in its current form could not function, hence the requirement for change. Therefore, the principal change under Seveso III is that the dangerous substances classification applied will relate to CLP. Both DSD and CLP regulations group dangerous substances but there is not a direct alignment between the groupings in these regulations. For example, in the case of flammable materials, there is a relatively neat transition between DSD and CLP categories with only minor changes to boiling point and flash point thresholds. For example, DSD classification R10 was for materials with a flash point of between 21 - 55C. Under CLP Category 3, this will now be 23 - 60C. However, the transition is more complex for acutely toxic materials. The DSD classifications were ‘very toxic (T+)’, ‘toxic (T)’ and ‘harmful (Xn)’, which have now been replaced under CLP by categories 1, 2, 3 and 4. Currently, ‘very toxic’ and ‘toxic’ materials only come into Seveso II, whereas for Seveso III it is likely to be categories 1, 2 and 3 for inhalation exposure routes and categories 1 and 2 for oral and dermal exposure routes. The alignment between DSD and CLP means than more acutely toxic materials, previously considered ‘harmful’ and thus outside of Seveso II, will actually be brought into Seveso III as category 3 materials. This may have significant implications for companies handling such materials. There are to be some new named substances in Annex 1 of the Seveso III Directive. For example, anhydrous ammonia - entry 35 and hydrogen sulphide - entry 37. In addition, biofuels are included in entry number 18 ‘Liquefied flammable gases’. The entry for heavy fuel oils has also moved from the ‘Dangerous for the Environment' category to entry number 34 ‘Petroleum products and alternative fuels’ in Seveso III. CHANGES TO DANGEROUS SUBSTANCES CLASSIFICATION It is not the intention of these changes to capture more companies under Seveso III. The expectation is that the majority of establishments will remain at their current Seveso status. However, the changes to dangerous substances classification are likely to result in some companies changing status:

• For current upper-tier establishments, no change is expected;
• For current lower-tier establishments, no change is expected. However, the changes to dangerous substances classification, particularly in terms of acutely toxic materials, could see some moving into upper tier;
• For current non-Seveso establishments, the changes to dangerous substances classification, particularly in terms of acutely toxic materials, could see some moving into lower tier and, in a minority of cases, the move could potentially be direct to upper tier.

Those companies moving to a higher Seveso status will need to collate appropriate documentation that previously was not required. For example, a company moving into lower tier will need to prepare a MAPP (Major Accident Prevention Policy). A company moving into upper tier will have to prepare a full Seveso Safety Report, which would then need to be maintained and updated at least every five years. Upper-tier sites may also be subject to more frequent inspections by the Competent Authority.
WHAT ELSE IS CHANGING UNDER SEVESO III? [caption id="attachment_10603" align="alignright" width="621"] Flammable material alignment (image courtesy of European Chemicals Agency www.echa.europa.eu. Click to enlarge)[/caption] The Seveso Directive now aligns with the Aarhus Convention on public information, public participation in decision-making and access to justice. In summary, this means that companies shall provide information relating to their activities pro-actively and not just on request. The information needs to be made available electronically and kept up to date. Article 14 of the Seveso III Directive requires the public to have access to information relating to the risks associated with activities on Seveso establishments and it also defines the right of the public to participate in projects and land-use planning. The public must also be given early opportunity to comment on off-site emergency plans as they are being developed. Under Access to Justice provisions, administrative and judicial review arrangements will be available if appropriate public access is not granted. However, under Article 22, information can be withheld if key confidentiality or security provisions are met. Work is currently ongoing in order to establish how much information and in what format this will be made available to the public. The expected approach is that each company would produce a ‘non-technical summary’ document, which summarises the process hazards and control measures on the establishment that are relevant to Seveso III. The idea behind these summary documents is to use common risk phrases that will be understood by the public and ensure consistency between sites, but also not to unduly increase the security risk. The Seveso III Directive places more emphasis on inspection. It provides prescriptive timescales for carrying out inspections and reporting on findings. The programme for routine inspections of all establishments will still be based on its risk profile, but there will be a specified maximum periodicity of inspection. Additional inspections will be required in important cases of non-compliance. WHAT HAPPENS NOW? The Seveso III Directive comes into law on 1 June 2015 and all companies must be compliant on this date. Waiting for this date to arrive before taking action is not an option. So what are the steps that companies must take now?

• Upper-tier establishments should already be producing or updating their Seveso Safety Report. This update should include the changes introduced by the move from DSD to CLP and also a check for any additional information required within Seveso III. Upper-tier sites should also monitor developments in relation to non-technical summaries.
• Lower tier and non-Seveso establishments should confirm their Seveso status and, where necessary, start preparing any additional data and documentation required by an elevated Seveso status.
• All establishments should consider whether a confidentiality or security request is necessary.

Producing a Seveso Safety Report is a legal duty. It is also a time-consuming process, potentially made worse if dedicated full-time safety personnel are not available. The initial step for companies finding themselves in this position should be a discussion with local inspectors from the Competent Authority in order to determine the correct level of detail required for relevant information, data and risk assessments and what gaps exist. A plan should then be developed to provide the relevant resources and information and fill the gaps. Stephen Beedle is the principal process safety consultant with ABB Consulting, based at the Belasis office of ABB Engineering Services. He is a chartered chemical engineer with 25 years’ experience in engineering design, operation and process safety. He is a principal consultant in the safety business, working in the areas of risk assessment, process hazard review and the Seveso Directive.