In a dangerous enterprise or in an enterprise with a major hazard, an activity licence or operation authorisation is needed to handle hazardous chemicals.
A hazardous chemical is a substance or mixture with properties that may cause damage to health, the environment or property.
The operation authorisation is valid for an indefinite period and is issued by the Consumer Protection and Technical Regulatory Authority (CPTRA).
Legal bases
The handling of hazardous chemicals is regulated by:
- the Chemicals Act;
- the General Part of the Economic Activities Code Act;
- Regulation No 10 of the Minister of Economic Affairs and Infrastructure ‘The procedure for determining the minimum level of hazardousness and threshold of hazardous chemicals and enterprise hazardousness’;
- Regulation No 18 of the Minister of Economic Affairs and Infrastructure ‘Requirements for mandatory documents of hazardous enterprises and enterprises with a major accident hazard, for drawing up such documents, for information for the public, and for notification of an accident’;
- Regulation No 5 of the Minister of Economic Affairs and Infrastructure ‘Special requirements for handling ammonium nitrate’;
- Regulation No 60 of the Minister of Health and Labour ‘Procedure for keeping records of hazardous chemicals’.
Requirements for applicants
In order to obtain an operation authorisation, the enterprise must determine its hazardousness category and then submit the following documents to the CPTRA for approval:
- data sheet (category C dangerous enterprise, category B and A enterprise with a major hazard);
- risk analysis (category C dangerous enterprise, category B enterprise with a major hazard);
- description of the safety management system (category B enterprise with a major hazard);
- safety report (category A enterprise with a major hazard).
In addition, regardless of the hazardousness category, the enterprise’s emergency plan must be approved by the Rescue Board.
Cross-border activities
An operation authorisation for handling hazardous chemicals is location-based and a foreign activity licence is not valid for operating in Estonia.
Completing and submitting an application
To obtain an operation authorisation, an application containing the following information must be submitted to the CPTRA:
- details of the applicant (name of enterprise, registration number, full address and contact details);
- details of the establishment (full address of the establishment, hazardousness category);
- proof of payment of the state fee;
- other supporting documents (e.g. liability insurance contract in the case of an enterprise with a major hazard, information on the environmental impact assessment report, if applicable);
- date of submission of the application, the name and signature of the applicant;
- in the case of a category A enterprise with a major hazard, the data sheet, safety report and emergency plan of the enterprise;
- in the case of a category B enterprise with a major hazard, the data sheet, risk analysis, description of the safety management system and emergency plan of the enterprise;
- in the case of a category C dangerous enterprise, the data sheet, risk analysis and emergency plan of the enterprise.
The application can be submitted:
- through the CPTRA’s supervisory information system JVIS; or
- by digital signature to the e-mail address [email protected] or
- by post to the CPTRA at Endla 10a, 10122 Tallinn.
The documents should preferably be submitted in electronic format.
Important information An operation authorisation under the Chemicals Act will not be granted if a hazardous chemical is handled on the basis of an integrated environmental permit under the Industrial Emissions Act, or a permit under the Explosives Act or the Weapons Act. In these cases, inspections are required for an operation authorisation under the Chemicals Act. For such cases, a dangerous enterprise or an enterprise with a major hazard must submit the obligatory documents together with the application for the abovementioned authorisations to the relevant competent authority, which may be the Environmental Board, the CPTRA or the Police and Border Guard Board.
Payment of state fee
A state fee of EUR 1 030 is charged for reviewing an application for an operation authorisation for a category A enterprise with a major hazard.
A state fee of EUR 900 is charged for reviewing an application for an operation authorisation for a category B enterprise with a major hazard.
A state fee of EUR 640 is charged for reviewing an application for an operation authorisation for a category C enterprise.
When paying the state fee, the service for which the state fee is paid must be indicated in the payment document or reference must be made to the provision of the State Fees Act on the rate of the state fee.
The state fee must be paid to the bank account of the Ministry of Finance, giving the reference number 2900082391:
- SEB – EE891010220034796011
- Swedbank – EE932200221023778606
- Luminor Bank – EE701700017001577198
Processing of applications
The CPTRA decides on applications for an operation authorisation within 60 working days from the date of receipt of all the required documents. The time limit for reviewing an application may be extended once by up to 30 working days. If deficiencies are identified during the application review, it is returned to the applicant to rectify such deficiencies, and the time limit for reviewing the application is suspended at that time.
If the CPTRA does not decide on the application within the above-mentioned time limit or within the extended period, the operation authorisation is not deemed granted by default.
An operation authorisation is granted to a person if:
- the operation of an establishment is possible given the surroundings of the establishment and the hazard and risk arising from the establishment, including if, on building the establishment or making alterations thereto that result in the risk of a major accident or an increase of the risk, the risks to the surroundings have been taken into account and sufficient measures have been taken to reduce these risks;
- the mandatory documents comply with the requirements of the Chemicals Act;
- the establishment is in accordance with the plan;
- the structure (building or facility) involved in handling the hazardous chemical has a building permit and use and occupancy permit, or a building notice and a use and occupancy notice (if required) have been submitted;
- equipment subject to an audit obligation related to the handling of hazardous chemicals has undergone a pre-use audit, has been found to be technically sound, complies with the requirements and is safe for further use.
When an operation authorisation has been granted, the applicant is notified by e-mail. In addition, the CPTRA notifies the Rescue Board, the Environmental Board and the local authority of the location of the enterprise granted the operation authorisation. The operation authorisation will be made public by the CPTRA via its supervisory information system JVIS. The operation authorisation is valid for an unlimited period.
Amending the terms of operation authorisations
In the event of changes in their activities that may have a significant impact on the risk of an accident or the hazard category of the enterprise, approval must be obtained for a new information sheet and, based on the hazardous category of the enterprise, any other obligatory documents.
In the event of a change of location of the activities, a new application for an operation authorisation must be made for the new location and an application must be submitted to conclude the operation authorisation for the old location.
In the case of the permanent closure or decommissioning of the enterprise, the CPTRA must be notified five working days before the closure or decommissioning.
Withdrawal of operation authorisations
If there is a breach of the terms of an operation authorisation or of the legal requirements, there may be grounds for withdrawing the operation authorisation. The issuer of the operation authorisation may revoke the operation authorisation if:
- the person has provided false information;
- the person has repeatedly or substantively breached safety requirements and thus caused a real accident hazard;
- the activities of the person in the enterprise no longer correspond to the activities described in the documents serving as the basis for issuing the operation authorisation, the hazards have clearly increased as a result of such activities and the person has failed to notify of the changed activities within the prescribed time limit and by the prescribed procedure;
- by activities permitted under the operation authorisation, the person has caused serious harm to the public order or a hazard that did not exist or was unknown at the time of granting the operation authorisation, that outweigh the person’s interest in continuing operations and cannot be eliminated by amending the operation authorisation;
- the person has not kept the mandatory documents up to date or adhered to the rules;
- the person has terminated the activity that is the subject of the operation authorisation.
If grounds for revoking an operation authorisation arise, the CPTRA may, given the circumstances, temporarily suspend the validity of the operation authorisation until the circumstances justifying the suspension have been eliminated or no longer apply.
Supervision
State supervision of compliance with the requirements imposed on dangerous enterprises and enterprises with a major hazard is the remit of the Consumer Protection and Technical Regulatory Authority and the Rescue Board.
Contact information
Additional information
Sirje Arus
Consumer Protection and Technical Regulatory Authority, Tel.: 667 2171, e-mail: [email protected]
Ardi Link
Consumer Protection and Technical Regulatory Authority, Tel.: 667 2027, e-mail: [email protected]
The CPTRA’s e-services and technical matters
CPTRA customer support, Tel.: 668 7080, e-mail: [email protected]