The Food Safety and Standards Authority of India (FSSAI) has issued draft regulations for third-party auditing of food business operators (FBOs) in India, aiming at a systematic and functionally-independent examination of food safety measures adopted by manufacturing units and claims made thereof.

Divided into six chapters and three schedules, the regulations describe in detail the procedure, planning, preparation, audit examination, etc., amongst others.

Under the regulations, there would be a recognised auditor and agency that would analyse the risk and undertake an audit to examine if the compliance is made according to the Food Safety and Standards Act, 2006.

The apex food regulator, along with the Quality Council of India (QCI), the Agricultural and Processed Food Products Export Development Authority (APEDA) and Export Inspection Council of India, will form a committee to evaluate the auditing agency and auditors.

Informing about the regulations, Pawan Kumar Agarwal, chief executive officer, FSSAI, said that high-risk foods would be addressed first, and subsequently the auditing would be made mandatory for all FBOs.

He added, “FSSAI has been working for regulations on third-party auditing for some time. We have finalised the draft, and it has been put out for the comments.”

“Foods having a high risk are on top of the agenda, and subsequently, the audit would be made mandatory for other food categories. This would also help in maintaining the requisite structure in a food safety ecosystem,” Agarwal stated.

He added that the auditing would be done more frequently when the infrastructure and the regulations are put in place.

“We want to create an ecosystem wherein FBOs would go for self-certification,” Agarwal said.

Meanwhile, under these regulations, FSSAI specified the procedure for recognition of the auditing agency and an independent food safety auditor and the process for conducting food safety audits, audit monitoring, audit reporting and management requirement.

The draft stated, “The Authority, from time to time, would declare the categories or types of food businesses which will be subject to mandatory third-party auditing, primarily based on their risk classification.”

“The classification of food businesses would be done after consideration of the major risk factors like the food type, the intended customer use, the nature of activity of the business, the volume of the business, the method of processing and/or any other factors that the authority may prescribe,” it added.

“Such food businesses shall get their business audited by the recognised auditing agency or independent food safety auditors as per the frequency prescribed by the food authority,” stated the draft.

Also, food businesses which are not mandatorily subject to third-party auditing, but are desirous of using this provision of getting audited by the recognised audit agency or auditors, can opt for the same.

The auditing agency or food safety auditor is also required to declare that there is no conflict of interest before accepting the food safety audit of an FBO.

The regulations also talk about the audit monitoring system. It said that the monitoring mechanism may include a review of the audit reports and performance, on-site assessment of the food safety auditors to ensure their competency of auditing the food safety management systems and the regulatory requirements; the assessment of the auditing agency on the basis of report of the accreditation body and any other mechanism as prescribed by FSSAI.

The regulations also talks about dispute redressals and record-keeping of the auditing done by the agency or the auditor. It is binding on both the auditor and the FBO to maintain records of the report, actions and rectification measures for a period of five years.