Establishment of a facility and finding out whether the operations require a permit

A production facility must take chemical safety into account at every stage of the facility’s life cycle from its establishment to when the facility is shut down.

Establishing a facility

A production facility, in which dangerous chemicals are stored or handled on a large scale, requires a permit from Tukes. With the help of the list of chemicals and the ratio, determine whether the operations are large-scale or not.

Apply for the permit required for large-scale operations well in advance, at least 8 months before the start of new operations. The information required for a permit application is presented in these instructions (in Finnish). In drawing up the application, you can use the application form for applications and notifications concerning large-scale industrial processing and storage. The processing of the application includes stages for hearing and request for statements.

If the quantities of hazardous chemicals you handle in the cacility are small, the activity is considered minor and notifying the rescue authorities is enough.

Establishing a production facility requires investigating the accident risks caused by chemicals. The decision on the location of the facility is based on the impact areas of the accident. The built environment, nature sites, groundwater areas and the land use planning of the area must be taken into account in the placement. The vulnerability of the environment is assessed based on the criteria determined by Tukes.

Facility design and construction

Good facility design takes risk and safety analyses as well as the decisions and instructions made based on them into account in order to reduce the risk of accidents.

You can choose the method of risk analysis to be used, but it must be suitable for the activities to be inspected and the scope of operations. State the methods used and the conclusions achieved with them the methods in writing in the permit application.

The following issues must be taken into account in the facility design:

In particular, identify the points of the operation, in which leaks may occur, and assess the consequences of possible leaks.
Find ways to prevent leaks and limit their consequences.
In the application, justify why the methods used are sufficient, or why they are not needed.
In the risk analyses, take account of the following issues:
- integrity of equipment, why the device does not leak?
- disturbances in the process
- leak management
- ignition sources and preventing them
- preventing the spread of fires, explosions and toxic gases
- chemicals as well as issues such as pressure and steam.

The safety requirements followed in the facilities are based on regulations and the measures found in the facility’s risk assessment (Act on the Safe Handling and Storage of Dangerous Chemicals and Explosives 390/2005 and Government Decree on Safety Requirements for Industrial Handling and Storage of Dangerous Chemicals 856/2012). The facilities can also fulfil the safety requirements by following various technical standards and instructions; complying with their level fulfils the requirements of the regulations.

How to draw up the list of chemicals

Lists of chemicals are maintained in the KemiDigi system.

How to calculate the ratio

You can use the calculator available on KemiDigi to find out the scope of your operations.

Apply for a permit from Tukes for the operations well in advance before starting the construction. The target processing time for the permit of a new facility is 8 months.

If the operations do not exceed the permit limit but do exceed the limit for notifications, notify the local rescue department about the operations (in Finnish).

The list of chemicals

Find out the maximum amount of the chemical to be stored, its hazard class, category and statements. You can find the hazardous properties in section 2.1 of the safety data sheet. You can get the safety data sheet from the chemical supplier.

An example of section 2.1 of the safety data sheet:

2. Hazards identification

2.1. Classification of the substance or mixture 1272/2008 (CLP)
Flam. Liq. 1, H224
Asp. Tox. 1, H304
Skin Irrit. 2, H315
STOT SE 3, H336
Muta. 1B, H340
Carc. 1B, H350
Repr. 2, H361
Aquatic Chronic 2, H411

An image of the section of the safety data sheet showing the hazardous properties of the chemical.

In the example, ‘Flammable liquid’ describes the hazard class, the number 1 after it indicates the category and ‘H224’ indicates the hazard statement.

When you use a mixture you have created by mixing at least one substance classified as dangerous with other substances, you must find out the classification of the mixture. For example, a chemical diluted with water is one such mixture. You can get help from the chemical supplier or other experts in the classification of chemicals. The less dangerous a chemical is, the fewer obligations you have.

The maximum amount of stored chemicals is calculated based on the total capacity of the tanks, even if the tanks are never kept completely full. The chemicals in the process equipment must also be taken into account.

Principles of calculation and an example

The sum of ratios s that determines the scope of operations is calculated as follows: s = q1/Q1+ q2/Q2… qn/Qn . In the formula, qn refers to the amount of the dangerous chemical in the production facility, and Qn refers to the minimum amount based on the classification of the chemical, Annex I, Part 1, or the chemical-specific amount, Annex I, Part 2.

If the value of the ratio s is 1 or less, the obligations of the facility are determined based on the scope indicated by the ratio.

The sum of ratios is calculated separately for each of the three hazard groups:

chemicals that are hazardous to health
chemicals that are hazardous to the environment
chemicals that pose a physical hazard, such as flammable or explosive chemicals.

When calculating the sums, each chemical is included in each of the abovementioned groups to which it belongs due to one of its hazardous properties.

You can use the following table (pdf, 344 kt , in Finnish) to help with the calculations.

The following chemicals are stored and processed in the facility:

45 t Anhydrous ammonia (Annex I/Part 2)
Press.Gas, H280
Flam. Gas 2, H221
Skin Corr. 1B, H314
Acute Tox. 3, H331
Aquatic Acute 1, H400
36 t Sulphuric acid 98% (Annex I/Part 1)
Skin Corr. 1A, H314
10 t Liquid oxygen (Annex I/Part 2)
Ox Gas 1, H270
6 t Liquefied petroleum gas (Annex I/Part 2)
Flam. Gas 1, H220
Compressed gas, H280

These chemicals have hazardous properties to be added together:

The sum of the ratios with the minimum amounts for large-scale operations is calculated, Annex I, Parts 1 and 2, column 2:
- chemicals that are hazardous to health: 45/10 + 36/1000 > 1
- chemicals that pose a physical hazard: 45/10 + 10/60 + 6/5 > 1
- chemicals that are hazardous to the environment: 45/10 > 1

The operations are large-scale, meaning that when at least one of the ratios is >1, based on all hazard groups, the facility must apply to Tukes for a permit.

It is calculated if the facility must draw up a major accident prevention policy document.

The sum of the ratios is calculated based on the minimum amounts for the obligation to draw up a major accident prevention policy document, Annex I, Parts 1 and 2, column 3. Note! The amount of sulphuric acid is not included in the sum, because a minimum amount for it has only been determined for the notification and permit obligation:
- chemicals that are hazardous to health: 45/50 < 1
- chemicals that pose a physical hazard: 45/50 + 10/200 + 6/50 > 1
- chemicals that are hazardous to the environment: 45/50 < 1

Because the ratio is >1, a major accident prevention policy document must be drawn up based on the amount of chemicals that pose a physical hazard.

The safety report permit limits are checked in the same way, Annex 1, Parts 1 and 2, column 4. In the case shown in the example, they were not exceeded for any of the groups.