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Although industrial activity has lead to economic development and improved living conditions, it has also brought with it a number of unavoidable hazards and adverse effects. One of these is the risk of accidents which can occur as a result of unanticipated explosions, fires and other releases, and which may cause harm to humans and the environment.

Notorious industrial accidents involving chemicals include the toxic leak at Bhopal (India, 1984) and the Exxon Valdez oil spill (Alaska, 1989). Although these incidents can be counted amongst the worst in history, there have been numerous other serious accidents over the years, including in recent years, such as the Prestige oil spill off the coasts of Spain and France (November 2002), the toxic pollution with benzene of rivers in Harbin, China (November 2005), and the explosion and fires at the Buncefield oil depot in the UK (December 2005).

The chief piece of legislation in Europe relating to the prevention and control of chemical accidents is the “Seveso Directive”, which has its roots in the aftermath of the industrial accident that occurred in Italy in the mid-70s.

In 1976, an explosion in a small chemical plant outside the town of Meda, in Italy’s Lombardy region, led to the release of a toxic cloud containing tetrachlorodibenzoparadioxin (TCDD) that contaminated a densely populated area of about 10 square miles between Milan and Lake Como. The cloud was concentrated around the municipality of Seveso, located downwind from the plant. 

Although there were no immediate human fatalities, repercussions from the incident included the evacuation of the most heavily contaminated zone (an area covering 110 hectares), the culling of 70,000 animals to prevent the toxins from entering the food chain, and the prohibition of farming in the less-contaminated zones.  It was eventually estimated that 37,000 people were exposed to the chemical.

The accident led to the adoption in 1982 of the European Union Directive 82/501/EC relating to major chemical accidents, which came to be known as the Seveso Directive. The legislation aims to prevent the occurrence of major accidents at sites that store, produce or make use of dangerous substances in sufficient quantities to constitute a serious health, safety and/or environmental risk, and to limit the consequences for people and the environment in the event of such an accident.

The Seveso Directive was amended twice (in 1987 and 1988) to broaden the scope, following a number of severe accidents which occurred during the mid 1980s. In 1996, the Directive was replaced by Directive 96/82/EC on the control of major-accident hazards involving dangerous substance, 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 extended in 2003 by Directive 2003/105/EC following the occurrence of a number of industrial accidents in 2000/2001.

Further adaptation of the provisions on major accidents occurred on 4 July 2012 with publication of a replacement directive - Directive 2012/18/EU, referred to as Seveso III. The changes included technical updates to take account of changes in EU chemicals classification, as well as better access for citizens to information about risks, how to behave in the event of an accident, more effective rules on participation in land-use planning projects related to Seveso plants, access to justice, and stricter standards for inspections. The Seveso III Directive 2012/18/EU has to be transposed and implemented by 1st June 2015.

The Seveso Directive is also considered to be the European Union’s legal and technical instrument to fulfil the obligations of the UNECE Convention on the Transboundary Effects of Industrial Accidents.

Scope of the Directive

The legislation applies to establishments where various dangerous substances are present in quantities equal to, or above, a given threshold. The legislation does not apply to certain activities and installations, such as military establishments, land-fills, hazards caused by ionising radiation, and the transport of dangerous substances outside the establishments.

The ‘dangerous substances’ to which the legislation applies are classified in two schedules in the legislation, which also specify the threshold quantities at which the establishment comes within scope of the legislation. The first schedule deals with named substances, such as chlorine, methanol, and petroleum products. The second schedule relates to 10 generic categories of substances, such as “very toxic” or “flammable”. 

The establishment’s capacity for producing or storing the dangerous substance, or substances, will determine whether it is within scope of the legislation, and if so, whether it qualifies as a lower tier or upper tier establishment.  Thresholds for named substances take precedence over the general categories; i.e. an establishment storing hydrogen is bound by the quantities specified for hydrogen, rather than those for explosive and flammable substances.

The legislation places various obligations on the operators of lower and upper tier establishments, such as notifying the competent authority of the presence of dangerous substances and having a major-accident prevention policy (MAPP) in place. Any changes in the amount or type of dangerous substances must be notified to the competent authority. Upper tier establishments have additional obligations, such as preparing a safety report and establishing a safety management system and an emergency plan, and informing persons in the vicinity (that may be affected by an accident at the site) of safety measures and requisite behaviour in the event of an accident. 

The authorities also have various obligations directly related to the establishments, such as inspections of the installation and review of the Safety Report or Major Accident Prevention Policy (MAPP), as well as obligations relating to emergency planning and land use planning.

External emergency plans have to be drawn up for all upper tier sites to specify the measures to be taken outside the establishment in the event of a major accident. These plans address scenarios where the effects of an accident require the coordinated intervention of national emergency agencies.

Land-use planning requirements apply for both lower and upper tier establishments, and include controls on the location of new establishments and modifications at existing establishments where dangerous substances are present, with the aim of maintaining appropriate distances between these establishments and residential areas, buildings and areas of public use, major transport routes (as far as possible), recreational areas and areas of particular natural sensitivity or interest.

Implementation of the Directive in Malta

The Directive has been transposed into Maltese law through the Control of Major Accident Hazards (COMAH) Regulations - L.N. 37 of 2003 as amended by L.N. 6 of 2005 and L.N 4 of 2014.

Twelve COMAH establishments have been identified in Malta, nine of which are upper tier sites.  The establishments are all designated as COMAH sites due to the type and quantity of fuels stored at the facilities.

List of COMAH establishments

Delimara Power Station, Marsaxlokk

Marsa Power Station, Marsa
Has Saptan Installation, l/o Ghaxaq
Ras Hanzir Installation, Paola
31st March 1979 Installation, Birzebbugia
Oil Tanking Malta, Birzebbugia
Gasco Energy, Birzebbugia
Wied Dalam Installation, l/o Birzebbugia
Mediterranean Offshore Bunkering Co Ltd, Marsa
San Lucian Oil Co. Ltd, Birzebbugia
LPG Storage Depot, San Lawrenz, Gozo
Easygas LPG Facility, Luqa

The LPG storage and bottling plant at Qajjenza, previously a COMAH site, is to be dismantled in the near future.

Competence for the COMAH Regulations, enacted under the Occupational Health and Safety Authority Act, is shared between the Occupational Health and Safety Authority (OHSA), the Environment Protection Directorate within MEPA, and the Civil Protection Department (CPD), with OHSA taking the lead in co-ordinating the administrative actions of the COMAH Competent Authority.

Operators of facilities that come within scope of the COMAH regulations because of the type and quantity of chemicals that are stored, handled or produced at the facility, are obliged to notify OHSA and submit the information required by the legislation within specific timeframes. The notification forms are available on the OHSA website.

The COMAH CA monitors the fulfilment of the operators’ obligations under the legislation and the management of the sites in relation to the prevention of major accidents and emergency planning.

"The land-use planning requirements of the Seveso legislation are addressed through the Development Control process guided by MEPA’s Supplementary Planning Guidance on Major Accident Hazards and Hazardous Substances, which also directs the type of development that is allowed in the vicinity of these establishments. Consultation zones have been drawn up around those sites in Malta which pose an immediate risk in the event of a major chemical accident, on the basis of risk criteria. Development within these zones is limited by the zone boundaries (inner, middle and outer) and the type and purpose of the proposed development, as well as its level of sensitivity. "

Given the nature of their activities and their coastal location, most of the sites also fall within the regulatory competence of the Malta Resources Authority and the Malta Maritime Authority.


Occupational Health and Safety Authority

Civil Protection Department 

European Commission – Seveso Directive

MAHB Major Accidents Hazards Bureau

United Nations Economic Commission for Europe, Convention on the Transboundary Effects of Industrial Accidents

European Chemical Substances Information System