25 July, 2018
General
The Food and Drugs Supervisory Agency (Badan Pengawas Obat dan Makanan – BPOM) issued Regulation No. 27 of 2017 on Registration of Foods (Regulation 27) on 20 December 2017. Regulation 27 came into force on 8 January 2018. The government had viewed that the previous regulation had to be adapted to keep up with the latest developments in the food sector. This new regulation revokes Head of the National Agency for Food and Drugs Control Regulation No. 12 of 2016 on the same matter.
Key Changes
The following are key changes under Regulation 27.
Requirement to have a product registration for Retail Packaging Food
Under the previous regulation, foods which are produced in Indonesia or imported and marketed in Indonesia must be registered with BPOM prior to distribution to secure distribution permits. Under Regulation 27, only foods that are in retail packaging are required to be registered. Retail packaging is described as the final packaging that should not be opened for additional packing and be traded.
Therefore, from a reading of the regulation, it is clear that if the products are packaged in bulk and sold in business to business (b2b) trading, the products will not be subject to the product registrations.
Exclusion for registrations
BPOM added types of food which are not required to be registered, i.e., (i) fast food and (ii) food which only had minimal processing (after harvesting), which consists of cleaning, stripping, drying, grinding, cutting, salting, cracking, mixing and/or pickling as well as not having food additives added, with the exception of food waxing additives.
Reregistration
Applications for reregistration can be submitted at the earliest 12 months and at the latest 10 days before the expiration of the validity period of a product registration (previously six months and at the latest 10 days).
Priority Service
Regulation 27 provides a priority service for applicants that are undertaking E-Registration.
The benefit of this priority service is the product registration will be issued within only 10 business days.
However, the following requirements must be fulfilled:
- The applicants have (i) fulfilled the requirements under the prevailing laws and regulations (ii) implemented risk management programs and (iii) secured best manufacturing practice food certificates on the production and/or distribution.
- The applicants have not previously been sanctioned.
- The applicants have not previously had any applications rejected for reasons of security of the products.
- The applicants have not been requested by BPOM to provide additional documents for the applications during any of their five most recent registration applications.
Given there is no provision on time limitation in point Nos. 2 and 3, strictly speaking, the applicants who have previously been sanctioned and had any applications rejected for reasons of security of the products cannot apply through this new system. We are not aware if BPOM has issued any product registration through this priority service system.
For further information, please contact:
Cahyani Endahayu, Partner, Baker & McKenzie
cahyani.endahayu@bakermckenzie.com
