Get More to Know with Genetically Engineered Food Product Circulation License

Get More to Know with Genetically Engineered Food Product Circulation License

“Genetically engineered food product (GE) is food that is produced or draws on raw materials, food additives, and/or other materials produced from genetic engineering processes.”

Some food products circulating in the community such as tomatoes, corn, soybeans, rice, soy milk, and others may have undergone a genetic engineering process.

The definition of genetic engineering of food based on Law Number 18 of 2012 concerning Food (Law 18/2012), is a process that involves the transfer of genes (carriers of traits) from one biological type to another of the same or different biological type.

This process is carried out to obtain new types of products that could produce superior food, such as additional durability, higher nutritional content, resistance to climate amendment, also support for certain pests and diseases.

Despite this technology being claimed in possession of various benefits as mentioned above, the government also reservations that the safety of the utilization of genetically modified food products (GM) shall be guaranteed.

That matter is defined in Law 18/2012, that, “Each person who carries out food production activities or processes is prohibited from using raw materials, food additives, and/or other materials produced from genetically engineered food that has not obtained food safety approval before being circulated”.

So, business actors who produce and/or import PRG food are required to use PRG food that has obtained PRG Food safety approval.

The PRG food safety approval is in the form of a PRG food safety certificate or also known as a genetically modified food distribution permit published by the Food and Drug Supervisory Agency (BPOM).

PRG Food Safety Approval as PB UMKU

Business licenses to support business activities (PB UMKU) are permits required for business activities and/or products during the operational and/or commercial stages of implementation.

PRG food safety approval or PRG food distribution permit is one of the PB UMKU that shall be fulfilled by business actors who have certain business activities in the processed food sub-sector.

Some of the business activities with the following Indonesian Standard Classification of Business (KBLI) codes are required to have RPG food safety approvals, including (Appendix III to BPOM Regulation Number 10 of 2021 concerning Standards for Business Activities and Products in the Implementation of Risk-Based Business Licensing for the Drug and Food Sector):

1. KBLI 01111 – Corn Farm
2. KBLI 01112 – Wheat Farm
3. KBLI 01113 – Soybean Farming
4. KBLI 01114 – Peanut Farm
5. And so on (in detail in Appendix III of BPOM Regulation 10/2021 and the Online Single Submission System (OSS))

PRG Types and Requirements

Based on Government Regulation Number 21 of 2005 concerning Biosafety of Genetically Engineered Products (PP 21/2005), the types of PRG include:

1. PRG animals, ingredients from PRG animals, from their processed products
2. PRG fish, ingredients from PRG fish, and their processed products
3. PRG plants, ingredients from PRG plants, and their processed products
4. PRG micro-organisms, ingredients from PRG micro-organisms, and their processed products

PRG food both domestically and from overseas, for distribution in Indonesia shall be eligible for several requirements to solicit PRG food safety approval.

The requirements in question are regulated in Appendix III of Perka BPOM 10/2021 and the official website of the Directorate of Processed Food Standardization of BPOM, including:

1. Common requirement:
   • Applicant data
   • Petition for food safety assessment of PRG addressed to the Head of BPOM
   • Integrity pact on data validity
   • PRG food data
2. Particular/Technical Requirements:
   • PRG food safety data, including:
     • Genetic information
     • General description of PRG
     • Description of the host and its application as a food
     • Gene source description
     • Description of the genetic transformation method
     • Characterization of genetic modification
   • Food safety information
     • Food safety information
     • Substantial equivalence
     • Amendment in food composition (for GM foods that are willfully improved in nutritional value or other components)
     • Allergenicity
     • Toxicity
   • Other data and documents

Based on Appendix I to BPOM Regulation Number 6 of 2018 concerning Food Control of Genetically Engineered Products (Appendix I of BPOM Regulation 6/2018), PRG food data contains primary information as a directive that the product qualifies food safety requirements, which include:

1. The genetic engineering method used to comply with raw procedures scientifically can be responsible for its validity
2. The nutritional content of PRGs shall be considered equivalent to those of non-GMs, except for the nutritional content which is the target of genetic engineering
3. The content of non-nutritive compounds (toxin compounds, anti-nutrients, and allergens) in PRG shall be substantially equivalent to that of non-PRG, except for the content of non-nutritive compounds which are the target of genetic engineering
4. The protein encoded by the transferred gene is not allergenic
5. The method of annihilation be used in the proceeding of deviation

In addition to the primary information above, Appendix I to BPOM Regulation 6/2018 also provides requirements associated with the data delivered to the applicant in the form of publications or company reports whose tests are carried out at:

1. Government laboratories;
2. Accredited laboratories; or
3. A laboratory that applies Good Laboratory Practice (GLP).

Procedure for the Submitting of Assessment Application PRG Food Safety

PRG food safety approval would be obtained after the PRG food safety assessment is carried out by the PRG Biosafety Commission (KKH). An application for an assessment could be submitted with the following steps (Appendix I of BPOM Regulation 6/2018):

1. File a written application for a PRG food safety assessment to the Head of BPOM by attaching the required data and an integrity treaty
2. If the application is declared incomplete, within 14 days from the completion of the inspection of the files, the Head of BPOM notifies the applicant to complete the required data/information.
3. The applicant is obliged to complete the lack of required data/information no later than 14 days after receiving the notification
4. If the application has been declared complete, within a period at the latest then 14 days the Head of BPOM commissions the KKH to conduct a food safety assessment of PRG

Responsibilities of Business Actors

After obtaining a PRG food safety certificate or PRG food distribution permit, food business actors are required to (Appendix I of BPOM Regulation 6/2018):

1. Convey
   • PRG food sampling
   • Control food (counterpart) sampling
   • Documents in the form of validated detection methods, primary sequence information, and site information to obtain raw comparisons (Certified Reference Material)
2. Draw on PRG food which has obtained PRG food safety approval.
3. If PRG food is traded in retail packaging, it is obligatory to include a label and statement regarding PRG food in the form of the words “GENETIC ENGINEERING PRODUCT”.

Penalty

Business actors who do not obey the provisions regarding the approval of PRG food safety are threatened with an administrative penalty in the form of (UU 16/2012):

1. Fine;
2. Temporary suspension of activities, production, and/or circulation;
3. Withdrawal of food from circulation by producers;
4. Compensation; and/or
5. License revocation.

In addition to the above, there are additional administrative sanctions in the form of a written admonition in BPOM Regulation 6/2018.

In a daze about how to apply for a PRG or other processed food safety approval? Feel free to contact us, Prolegal!

Author: Faiz Azhanzi Yazid

Editor: Bidari Aufa Sinarizqi

Translator: Angelie Kartika Putri