The third update of the Seveso Directive, the main EU legislation that governs the control of major accident hazards involving dangerous substances on land, comes into force on 1 June 2015. Terry Woolmer reports on the potential implications for industry.
The first Seveso Directive was adopted in 1982 and came about because of a serious dioxin release in Italy during 1976, which caused serious land contamination and dioxin poisoning.
The original directive has evolved in scope over the years to reflect some of the recommendations arising out of the Bhopal disaster in 1987 and the Rhine pollution incident in 1988 involving organophosphate pesticides.
Adopted in 1996, the Seveso II Directive is known in the UK as the Control of Major Accident Hazards (COMAH) Regulations 1999. The second update’s broader scope was aimed at preventing and mitigating the effects of major accident hazards involving dangerous substances, which can cause serious damage or harm to people or the environment. It also brought in new requirements relating to safety management, emergency and land-use planning.
Under Seveso II and the COMAH regulations, chemicals are currently classified under the Chemicals (Hazard Information and Packaging for Supply) Regulations. These are gradually being replaced by the globally harmonised system (GHS) for the classification, labelling and packaging of chemical substances and mixtures and the EU’s Classification, Labelling and Packaging (CLP) Regulation for the classification of chemicals. CLP becomes fully effective on 1 June 2015 at the same time as Seveso III.
Impact on UK manufacturers
Although the current COMAH regulations mainly apply to the chemical processing industry, they are also applicable to more conventional manufacturing facilities, e.g. pharmaceutical or engineering companies as well as some types of storage facility, including those storing ammonium nitrate and ammonium nitrate-based fertilisers.
The linkage that exists between GHS, CLP and Seveso III may mean that substances reclassified by CLP adaptations to technical progress (ATP) will fall within the scope of Seveso III. Substances previously outside the scope of the current directive will now have to be re-considered when deciding whether or not a company has to register as a lower or upper tier COMAH site.
One example is the use of nitric acid. This is commonly used in the manufacturing sector for a number of applications, including metal treatment/surface treatment as well as cleaning out pipework in the food and drink industry. It is stored in significant quantities on many sites.
A process has started within the EU (proposed by Germany) to reclassify nitric acid as ‘acute toxic category 1 by inhalation’ under the EU CLP regulations. At present, it is categorised as a category 3 oxidising liquid and corrosive to the skin.
There is considerable concern in the UK’s manufacturing community about the unintended downstream COMAH consequences of reclassifying nitric acid.
The EU’s European Chemicals Agency (ECHA) agreed in May 2013 that nitric acid should be reclassified. ECHA passed its opinion to the European Commission so that Annex VI of the CLP regulations can be formally updated this year.
After publication in the EU’s official journal, member states will have about 18 months to implement this change. We can anticipate that the revised classification for nitric acid will apply at around the same time that Seveso III comes into force.
The reclassification will mean that Seveso III and any updated COMAH regulations automatically apply. Establishments holding qualifying quantities of nitric acid at a specific concentration could be drawn within the scope of the UK’s major hazard regulatory regime (COMAH) at either tier 1 or tier 2. Even if the quantity held on-site is less than these thresholds, the application of the aggregation rules may result in the site falling within the scope of COMAH.
The manufacturing sector is concerned that nitric acid will be brought into scope, yet in its view does not have a ‘major accident potential’ when set against the criteria outlined in article 4 of the new Seveso III Directive. The sector is concerned that firms will be brought into a complicated and costly COMAH control regime without reducing risk or exposure levels. This is likely to have a significant business impact on many small-to-medium-sized enterprises in the metal/surface treatment sector as well as larger manufacturing organisations.
On a general point about classification, EEF is concerned with the automatic link between the CLP regulations, REACH and the Seveso Directive and the way in which substances come into the regime if they fall into one of the categories in annex 1 of the Seveso III Directive, whether or not they have major accident potential.
Unfortunately, when the Seveso III Directive was negotiated, an agreement could not be reached on a legal instrument to take substances that are reclassified under CLP out of scope of the Seveso III Directive if they did not have major accident potential.
Legally, the only way this can be achieved is through the ordinary legislative procedure whereby the European Commission puts forward a proposal to change the directive and it is then negotiated with the EU Parliament and the EU Council. This will take time. Nevertheless, the unintended consequences of the automatic link are still a topical issue in Europe, and something that HSE is trying to resolve.
In the case of nitric acid, one possible short-term solution is to determine whether its major hazard potential can be related to its concentration, potentially ruling out the need for sites to become COMAH-registered if they only use nitric acid at lower concentrations.
However, it is unclear at this stage whether amendments can be made to the directive to resolve this issue or whether ‘major hazard potential’ criteria should be a factor that EHAC should consider when it reclassifies chemical substances in the future.
Nitric Acid is only one example that has been identified. It is possible that other substances will be captured by this automatic link between GHS, CLP and Seveso III with adverse and unnecessary consequences for industry. Companies should fully consider the implications of Seveso III before it comes into effect on 1 June 2015.
The main approach to Seveso III remains the same in that it covers the consequences for both human health and the environment. Fundamentally, it still covers identification of the hazards and risks, effective controls and mitigation. It will also have the same component parts, including safety management of sites capable of major accident hazards, emergency planning, land use planning and inspection.
Priority for UK companies
Companies should find out soon whether they fall within the directive’s scope.
The alignment to new international chemical classification is not straightforward for health hazards. Although this has been implemented into Seveso III, the categories for CLP do not match with the previous COMAH/CHIP system, so the regulation of some substances will inevitably change.
Determining whether or not the directive applies will become more complex for industry, e.g. mixtures; particularly for sites near limits close to top tier or just outside the scope of the COMAH regulations. Operators of sites will have to carefully consider, using annex 1 of the new directive, what the changes to the scope mean for them.
There is potential for sites to change their COMAH status (top tier, lower tier or non-COMAH) when the new directive is implemented, depending on the substances and quantities held. Many establishments will have to re-notify existing COMAH sites because of the changes brought about.
The European Commission (EC) has modernised the directive in relation to information to the public, access to justice, and public participation. There are now more public information requirements. There will be a strong presumption that information should be made available to the public and therefore it will, potentially, be difficult for industry to keep safety reports out of the public domain.
The EC’s objective was to update the directive in line with the Aarhus Convention so that the level and quality of information is improved, particularly for people likely to be affected; that companies actively provide more information (not just on request); and that it should be available electronically and be kept up to date.
Electronic information will need to be made permanently available for all COMAH establishments and cover what should be done in the case of an accident as well as the date of the conclusion of the last inspection by the regulatory authority. Top tier sites will also have to provide information on the main types of major accident scenarios, information from the external emergency plan and resubmissions of the safety report.
COMAH notifications will now have to include information about neighbouring establishments and sites and dangerous substances using CLP classification. Additional information will be required in safety reports and be submitted in set timeframes. The public, which may be affected by a COMAH site, will have the opportunity to express its views on external emergency plans. However, this may have implications for industry in terms of security.
HSE has developed an impact assessment, which was released in May to coincide with its formal consultation (the closing date is 27 June). The new COMAH regulations will be laid in the Houses of Parliament early in 2015. HSE intends to publish guidance three months before the new COMAH regulations come into force (March 2015).
Email: [email protected] to share views on the new directive and its impact on the sector.
Terry Woolmer is head of health and safety policy at EEF
Postscript
Since this article was written Germany has formally asked the European Commission to postpone the inclusion of nitric acid in the proposed 7th ATP (Adaptations to Technical Progress) to CLP. Germany indicated it wishes to go back to the committee for risk assessment (RAC) with an update to its dossier.
The RAC opinion currently refers to the classification of pure nitric acid as acute toxic 1 for inhalation. Concentrations of nitric acid above 70 per cent induce the formation of gas and vapour. In less concentrated aqueous nitric acid solutions only small amounts of vapour arise due to the low vapour pressure.
The entry in CPL resulting from this will have great practical consequences for the classification of various aqueous solutions of Nitric Acid with concentrations below 70 per cent with respect to acute toxicity for inhalation.
Germany’s request for a postponement is clarify whether a differentiation is required for different concentrations of nitric acid. The European Commission is currently reflecting on this request.
Why is it that UK just says there is a problem, but Germany seems able to do something about it?