1. Seveso III Directive Moving from Seveso II to Seveso III
This presentation covers:
brief background – on the Seveso Directive
main changes & likely implications (still being determined)
timetable
sources of further info
It should last for approximately 30mins.

2. Background to Seveso Directive
1. Seveso I adopted in 1982 to control major accident hazards
2. Current COMAH Regs 1999 and planning legislation implement Seveso II
3. Seveso III necessary as CHIP being replaced by CLP by 2015
4. Overall purpose & approach to stay the same
Identification of sites, controls and mitigation
5. European Commission also took opportunity to modernise the Directive
Public info
Access to justice
Public participation
Inspections
1. The Seveso Directive is a well regarded & established Directive for the control of major accident hazards. The first Seveso Directive was adopted in 1982.
2. Seveso II is implemented in the UK through the current COMAH Regulations and planning legislation (planning legislation is the responsibility of the Department for Communities and Local Government (CLG) in England and the devolved administrations in Scotland and Wales).
3. Application depends on inventory of dangerous substances, currently defined using CHIP (Chemicals (Hazard Information and Packaging for Supply) Regulations eg toxic, very toxic etc. But CHIP is on the way out and the CLP (Classification, Labelling and Packaging of Substances and Mixtures) Regulations are on the way in. Without the new Seveso III Directive, Seveso/COMAH would cease to function.
4. The main approach stays the same: 3 part strategy: identification; controls; & mitigation. Seveso III will have the same component parts: safety management of sites capable of producing major accident hazards, emergency planning, land use planning & inspection. As referred to above the land use planning legislation is the responsibility of the Department for Communities and Local Government and the devolved administrations.
5. Seveso III covers the consequences for both human health & the environment. The Commission also took the opportunity to modernise the Directive in relation to 1. Information to the public, access to justice, public participation which are all key themes that the European Parliament and the Commission want in Environmental Directives. The system for inspection was also updated but there is little change for the UK – more detail follows in this presentation.

3. Current situation
1. Seveso III adopted on 4th July
2. New COMAH Regs to be in force from 1June 2015
3. Heavy fuel oil - amendment to current COMAH Regs from 15 Feb 2014
4. Main areas of change:
Scope
Public information
Inspection
Lack of correction system for substances moving in or out of scope
1 & 2.The Seveso III Directive was adopted on 4th July 2012 and new COMAH Regulations will need to be in force from 1st June 2015.
3. Heavy Fuel Oil (HFO) – there will be an amendment to the current COMAH Regulations which will come into force from 15th February The amendment will put HFOs into the ‘petroleum products’ category of Schedule 1 with the same thresholds. This will have the effect of taking some sites out of scope of COMAH who have quantities of HFOs in the lower ‘Dangerous for the environment’ classification. HSE will be consulting on this in the Spring of 2013.
4. The main areas of change in the Seveso III Directive are:
Scope – how the system will move from CHIP classification to CLP – i.e. which substances are in/out.
Public info – more requirements than in Seveso II.
Inspection – kept the current approach of hazard/risk based inspections.
Correction system – there is currently no legal method for taking substances out of scope of the Seveso III Directive ie substances which come into scope of the CLP classification but are considered not to have major accident potential. There is however, provision for Member States to notify the European Commission of any substances it considers not to have major accident potential. There is currently work going on in Europe to look at this but there is no easy solution as any change would require the Commission to put forward a proposal to amend the Directive.
The following slides look at the main areas of change in more detail…

4. Scope
Early indications – only a small movement of sites coming into/going out of scope
Helpful amendments on named substances
Determining whether the Directive applies will be more complex
Article 2 - Scope - refer to Annex 1 of the Seveso III Directive to see the changes.
1. From initial research – not much movement; expect a very small net movement of sites out of scope of the Directive.
2. Helpful amendments on named substances, eg biogas, alternative fuels, Sodium Hypochlorite, HFOs – implications if using??
Should result in fewer new sites coming in than under the Commission’s original proposal…...
3…… BUT working out whether the Directive applies will be more complex for both industry & regulators eg mixtures; particularly for sites near limits close to top tier or just outside of scope of the COMAH Regulations. Operators of sites will have to carefully consider, using Annex 1, what the changes to scope mean for them. The Health and Safety Laboratory (HSL) offer a training course about how to align substances.

5. Toxicity - Seveso III alignmentEU
Oral
mg/kg
Inhalaton vapour
mg/l
Inhalation aerosol
Inhalation gas
ppmV
Dermal 1 2 3 4 ? T Xn T+
Alignment to new international chemical's classification – not straightforward for health hazards
On this chart, the top bar in blue represents the old system in the EU, ranging from Very Toxic in dark blue to Harmful in light blue.
The brown, red, orange and yellow bars show the ranges of Categories for CLP. Category 1 is the most toxic on the left hand side, going down to category 4 over on the right.
We also have the three exposure routes shown: Oral at the top, Dermal second and the three at the bottom represent the inhalation exposure route. For the inhalation exposure route, substances are classified differently according to their physical state. They can be inhaled as vapours, aerosols – often called dusts and mists - and gases at the bottom.
This dark blue vertical line, represents where the Toxic / Very Toxic boundary was for the old system for each exposure route.
The lighter blue vertical line shows the same thing for the Toxic / Harmful boundary.
As you can see, these lines go through the middle of many of the CLP categories, so some substances that are category 3 for oral, would previously have been labelled as toxic, whereas others with a lower LD50 but still category 3, would have previously been called harmful. Category 3 for dermal has the same problem. It can also be seen that category 2 for oral and for inhalation of aerosols consists of substances that are currently labelled as T+ or T.
Also to bear in mind, for inhalation of gases, CLP uses completely different units from the old system. CLP uses ppm (parts per million) whereas the units used under Seveso II are mg/L (a measure of the weight of the substance in a litre of air). The US currently uses ppm in their classification system, it is a unit of measure that takes unto account the molecular weight of the substance because it relies on the number of molecules present rather than the weight.
The use of ppm instead of mg/L can have a dramatic effect on how a substance is classified, particularly for those substances with a low molecular weight. The two systems are completely different and cannot be compared directly for the inhalation of gases; the position of the blue lines for the gases will be different for every single substance because ppm is dependant upon the molecular weight.
So you can see from this chart that although the members of the EU have negotiated how to implement these categories into Seveso III, the categories for CLP do not match with our old system and so the regulation of some substances will inevitably change.

6. Public information 1. More requirements than before
2. Public info on safety measures for all establishments (not just top tier as present)
3. Extra provisions for top tier re safety reports
4. Available electronically and kept up to date
Refer to Article 14 – Information to the public
1. There are more public information requirements than previously. The Commission’s objective was to update the Directive in line with the Aarhus Convention ( on public info, public participation in decision making & access to justice on environmental matters) i.e.
- level & quality of information to be improved, particularly for people likely to be affected
- active provision of more information – not just on request
- available electronically & to be kept up to date
2. Information about all establishments (not just top tier as at present) (See Annex V – for full list, Part 1 for all establishments) to be permanently electronically available including:
- what to do in case of an accident
- last site visit (inspection) or electronic reference to where that information can be found
3. For Top Tier:
- information on main types of major accident scenarios.
- info from external emergency plan.
- changes to when the safety report requires updating and re-submitting
4. Public information (Annex 5) will need to be permanently available, including electronically and will need to be kept up to date.

7. Public information 1. Culture shift!
2. Confidentiality & security issues
3. Access to justice – difficult issue
1. These requirements are quite a shift in culture on the provision of public information from where we are at the moment.
2. There will be a strong presumption to make information available to the public unless confidentiality provisions are met (refer to Article 22).
There will no longer be a Secretary of State direction to keep safety reports out of the public domain – they will have to be considered on a case by case basis. HSE is working with the Security Services on implications & finding a way forward.
There is a provision in the Directive to make summaries of the safety report available. The Competent Authority is currently working with the Security Services and some current COMAH establishments to see what such a summary may look like.
3. This is a difficult issue. Under the Access to Justice provisions
– there will need to be administrative & judicial review arrangements if any request for information is withheld and subsequently challenged
- arrangements for judicial review in relation to public participation in planning matters.

8. Inspections
1. Will maintain current system - frequency of site visits based on risk/hazard profile
2. Relevant findings of inspections under other EU legislation to be taken into account in hazard/risk assessment of sites
3. Inspections where poss to be coordinated with other EU legislation inspections
1. The requirement in Seveso III maintains the current system ie flexible risk/hazard-based inspection frequencies.
2&3. Thought will need to be given to these two issues i.e. how to take into account relevant findings from other EU environmental legislation & co-ordinate inspections if possible. Ideas will be developed during the transposition stage.

9. Other key issues 1. Notifications 2. Safety reports 3. Emergency plans
4. Transitional arrangements
The significance of these ‘other key issues’ should not be underestimated.
1. Notifications will now have to include information about neighbouring establishments and where available any changes in substances.
Many establishments will have to re-notify because of the change.
There are new definitions of establishment with different timeframes to take into account the change from Seveso II to III (refer to the Directive, Article 3 ‘Definitions’).
2. Safety Reports – additional information is required in safety reports – so changed parts will have to be submitted within set timeframes. Timing in submission will need to be worked out.
3. External emergency plans - the ‘public concerned’ (See Article 3 for definition) will have the opportunity to give its opinion on external emergency plans. In terms of implementation consideration will be given to this requirement and any potential national security concerns.
4. Transitional arrangements – will be developed during the transposition stage.

10. Timetable
1. Now – end of 2013 –informal consultation with industry and stakeholders
2. Early 2014 – formal consultation; heavy fuel oils amendment to COMAH Regs 1999
3. Early 2015 – lay Regulations & publication of guidance
4. 1 June 2015 – new COMAH Regs enter into force
1. From now to the end of 2013 should allow enough time for HSE to work with other parts of Government and industry to ensure that any potential issues for implementation into national legislation are identified. This timeframe should allow industry the time to plan for the change.
2. Formal consultation by HSE will take place early in An impact assessment is currently being developed and will accompany the formal consultation document. (For HFOs the COMAH Regulations 1999 will be amended in February 2014).
3. The new COMAH Regulations will be laid in Parliament early in Guidance will be published 3 months prior to the new COMAH Regulations coming into force (i.e. March 2015).
4. The new COMAH Regulations will come into force on 1st June 2015

11. Sources of information
1. Seveso website revised and will continue to be updated. Current features include;
- information about Seveso III
- implications for business
- FAQs
2. Seveso ebulletin
3. Guidance
1. The Seveso website was revised in March 2013 to reflect latest information regarding Seveso III. It will continue to be updated as the transposition progresses, particularly the resources page as products are developed, and the Q&A section.
2. You can subscribe to e-bulletin to receive updates about Seveso III.
3. Current guidance on the COMAH Regulations is available (refer to link on the slide). HSE in collaboration with other Government departments will develop guidance on the new COMAH regulations which will be published three months before the regulations come into force.

12. Questions & discussion
If any questions are raised which cannot be answered they can be sent by to or by post to HSE, Hazardous Installations Directorate, Chemical Industries Policy, 5S2 Redgrave Court, Merton Road, Bootle, Merseyside L20 7HS
A generic account has been set up to deal with any queries relating to the Seveso III Directive. It is acknowledged there will be detailed questions some of which HSE will not be in a position to answer until full details about implementation have been decided. The account will be monitored but you may not necessarily receive a reply, instead queries sent to the account will be used to generate further material to go on the Seveso III web-pages, so it may be useful to regularly monitor those pages.
Alternatively queries can be sent to HSE at the address given above.