NEA License Application Singapore – Requirements And Process

NEA license application is necessary for a business or individual that conducts activities that have an impact on the environment in Singapore.

NEA stands for The National Environment Agency, which is the environmental regulatory authority in Singapore.

There are various types of NEA licenses, including licenses for food establishments, public waste collection, hazardous waste management, and pollution control. These licenses are issued to ensure that the activities conducted by businesses and individuals do not cause harm to the environment and comply with environmental regulations.

Businesses and individuals must apply for an NEA license before starting their activities, and they must comply with the conditions of the license.

If you are interested in knowing more about establishing a new business here, refer to Singapore company registration.

LICENSES FOR IONIZING RADIATION

• IR1 license: Applicants who wish to produce, hold for sale, or engage in business with irradiating apparatus, radioactive materials, or devices incorporating radioactive materials must obtain this license.
• IR2 license: Applicants who wish to store, hold for use (other than sale), or utilize irradiating apparatus, radioactive materials, or devices incorporating radioactive materials must obtain this license.
• IR3 license: Applicants who want to handle and transport radioactive materials must have this license.
• R1 Registration: Radiation worker registration. This certification is necessary for candidates planning to undertake or carry out radiation work involving radioactive materials, devices containing radioactive materials, or ionizing radiation irradiating apparatus.

NON-IONISING RADIATION LICENCES

• N1 license: Applicants who wish to produce, own, or deal in non-ionizing irradiating equipment must obtain this license.
• N2 license: Applicants who wish to keep or possess non-ionizing irradiating equipment for use must obtain this license.
• N3 license: For those who want to utilize laser equipment to perform or carry out work, this license is necessary.
• N4A/B license: Applicants who want to import or export a shipment of non-ionizing irradiating equipment must have this license.

IMPORT AND EXPORT

IR4A/B license: For applicants planning to import or export a shipment of ionizing radiation-generating equipment, this license is necessary.

IR5A/B license: Applicants who want to import or export a shipment of radioactive materials or devices containing radioactive materials must get this license.

IR5C license: This licence is required for applicants intending to transit or tranship a consignment of nuclear materials.

Tranship a shipment of radioactive material: To apply for approval to tranship a shipment of radioactive materials. 

REQUIREMENTS FOR NEA LICENSE

• The applicant must be a Singaporean citizen, a permanent resident, or possess a valid work visa in order to be eligible.
• When re-applying for a certificate that has expired or applying for registration as a radiation worker, a medical examination is necessary.
• The Radiation Protection Act and its ancillary Rules must be followed by the applicant or registrant.
• Depending on the kind of radiation work the applicant plans to do, there are different requirements for obtaining registration.

LIST OF RADIOACTIVE SUBSTANCES AND CONTROLLED IRRADIATION APPARATUS

The business must apply for the necessary radiation license(s) from NEA if they own any of the equipment or materials listed below.

USING IRRADIATING EQUIPMENT FOR TESTING, DEMONSTRATION, OR RESEARCH PURPOSES

If the apparatus is going to be powered up for demonstration, workshops, or trials, it needs to be authorized under a possession licence (IR2 or N2). There is no requirement that the license holder be the customer or the seller. However, the licensee should be aware of any potential licensing restrictions (e.g. vendor representative may be required to be present for use of the apparatus).

Since license holders are directly accountable for the apparatus covered by their permits, it would be up to the licensee to change the apparatus’s storage location if they wanted to move it. When moving an apparatus from one storage location back to a previously used storage location, licensees should record this in the amendment application and include information like the date of the most recent inspection (if available). It might not be necessary to conduct another inspection to enable the adjustment if the storage facility to which it is being moved has already undergone one.

Being the license holder could be more convenient in situations where the vendor’s equipment is intended to be moved to different customers’ locations for brief use (e.g., situations where equipment is utilized for trial, demonstration, training, etc.). Instead of every client requesting a new license each time, the vendor would be able to file for a license amendment for each transfer.

A dealer license (IR1 or N1) or a possession license can be used to authorize an item if it cannot be powered on (IR2 or N2).

It is necessary to acquire the necessary licenses or registrations for equipment that can only be used by authorized users.

Demonstrations, exhibitions, and workshops are generally not deemed ’emergency cases’ as they are anticipated to have been prepared in advance. So, submitting a license application at the last minute with the risk that it won’t be approved in time for the demonstration, exhibition, or workshop would often not be deemed suitable for expedited processing.

LICENSE REQUIREMENTS FOR RADIOACTIVE MATERIALS AND IRRADIATING APPARATUS USED FOR MEDICAL PURPOSES

In Singapore, medical devices are governed under the Health Products Act (HPA) and its Health Products (Medical Devices) Regulations, which are administered by the Health Sciences Authority (HSA) (HSA). HSA evaluates the registration of medical devices based on:

• Risk classification
• Number of prior approvals given by their overseas reference regulatory agencies
• Duration of safe marketing history

When submitting an application, applicants who want to import, possess for sale, or deal in medical equipment that emits radiation should check with the Medical Device Branch (MDB) under HSA to make sure the equipment is registered and listed on the Singapore Medical Device Register (SMDR), or is authorized by HSA via the Special Access Routes (SAR) approval.

For radiation-emitting medical apparatus, the following documents have to be provided:

• At least one of the five reference agencies has granted regulatory approval (US Food and Drug Administration, Health Canada, Australian Therapeutic Goods Administration, Japan Ministry of Health, CE marking) (for non-ionizing radiation used to irradiate lasers and ultrasound machines)
• An email acknowledging receipt of a product registration approval from the Medical Device Branch of the Health Sciences Authority (MDB-HSA)
• Other types of MDB-HSA special acknowledgment

PRE-LICENSING INSPECTION

If a pre-licensing inspection is necessary to assess an application, NEA inspectors will get in touch with the license applicants. The officer will schedule the inspection date and time and let the contact person know if there are any additional requirements. Typically, someone authorized to represent the application organization as well as a licensee permitted to utilize the irradiating equipment or radioactive material should be present during the inspection. All NEA officers conducting on-site inspections will be in possession of an authority card and staff permit that enables them to carry out the responsibilities set forth in the Radiation Protection Act and its regulations.

MEDICAL EXAMINATION REQUIRED FOR N3 AND R1 APPLICATIONS

When applying for a new N3 license or R1 certificate, as well as when reapplying for a license or certificate that has expired, a medical examination is necessary. The medical certificate form may be found on NEA ePortal: Miscellaneous Forms.

Bring the Medical Certificate Form for R1 Applicants (MC-1) to a nearby medical facility to set up a blood test in order to register for R1. The form should be filled out by the doctor.

Visit an eye clinic and complete the medical eye examination for the N3 user license using the Medical Certificate Form for N3 Applicants (MC-2). The form will be completed by the ophthalmologist and then given back to the applicant.

Include the filled and signed medical certificate form in the online application on the GoBusiness Portal as a supporting document. A copy of the medical certificate form should be kept for the personal records. Unless specifically specified by NEA, no other types of documentation or certification will be accepted in place of the MC-1 or MC-2 form.

TRANSFERABILITY OF RADIATION LICENSES/REGISTRATION

For N3 licenses and R1 certificate holders

The user license or registration will still be valid if the employer changes because they are linked to the applicant’s identity number. Owners of an N3 license or an R1 certificate should be aware that in order to work for the new employer, they must be able to use an irradiating device or do the specific sort of radiation work that is authorized by the license or certificate. To update the license to reflect the purpose of use, N3 license holders must submit a license modification application. In order to update the certificate to reflect the sort of radiation work they are doing, R1 certificate holders must submit a license amendment application.

All other licenses

Licenses connected to UEN are often non-transferable across organizations. When ownership of licensed radioactive materials or irradiating equipment is transferred from one organization to another, the original organization must request that the license be revoked, and the new organization must submit an application for a new license using its UEN.

There may be exceptions in situations when a change in UEN results from mergers, amalgamations, or other processes where the former organization is legally acknowledged as becoming the new entity. 

APPLICATION PROCESS FOR NEA LICENSE

To apply for a license with the National Environment Agency (NEA) in Singapore, you can follow these general steps:

• Determine the type of license needed

The NEA issues various licenses for activities such as food retail, food manufacturing, public waste collection, and hazardous substances handling. Make sure to identify the correct licence based on the business activity.

• Prepare the necessary documents

The application requirements may vary depending on the licence, but generally, the applicant will need to provide basic business information, such as the company name and registration number, as well as specific documents related to the activity. For example, if applying for a food licence, one may need to provide a food hygiene certificate or a floor plan of the premises.

• Submit the application

The applicant can submit the application online through the NEA’s LicenceOne portal. They will need to create an account and follow the instructions to fill out the application form and upload the necessary documents. They will also need to pay the application fee at this stage.

• Wait for processing

The processing time for NEA licence applications can vary depending on the type of license and the complexity of the application. The applicant can check the status of the application through the LicenceOne portal.

• Receive the license

If the application is approved, the applicant will receive the licence through the LicenceOne portal. Make sure to read and understand the conditions and requirements of the licence, as is necessary to comply with them.

NEA APPLICANTS SHOULD FOLLOW THE LISTED THINGS

• pay the annual fee for their licenses or certificates by the anniversary date; 
• timely renew their licenses by submitting renewal applications at least one month prior to the license expiration date;
• ensure that license information, such as the storage location and list of equipment and radioactive materials, are accurate and up to date; 
• promptly update the customer profile when a point of contact changes (such as name, phone number, and email address); 
• timely update the worker management when a radiation worker is added or removed; and 
• obtain permission from the NEA before disposing of or decommissioning equipment or radioactive materials or canceling licenses that are no longer needed.

Reach out to us at Relin Consultants for more information. Our team can assist you with NEA license applications.