We are all awakened by a notification placed on January 15, 2023, which is as follows:
Order: Manufacturing (including repacker and relabeler) to upload or link mandatory lab testing reports (six monthly) on FoSCos.
This notification says the following: “It mentions the condition of all FSSAI licences, which has been present in all licences since 2011. However, FSSAI never asked for an upload of the testing reports.
The licence condition is as follows:
The condition of licence number 12 (Annexure 2) of Schedule 2 of the FSS (Licencing and Registration) of Food Business, 2011 specifies that the food business operator shall “ensure testing of relevant chemical and/or microbiological contaminants in food products in accordance with these regulations as frequently as required on the basis of historical data and risk assessment to ensure production and delivery of safe food through own or NABL-accredited/FSSAI-notified labs at least once every six months.
What is the meaning of this? –
It has a simple meaning: every six months, we should get our finished product analysed from an NABL and FSSAI-notified lab against the chemical and microbiological parameters mentioned against the product category in FSSAI.
Is this the new requirement?
This is not a new requirement; it has been there since 2011 and is marked in each licence.
What is the timeline mentioned in the notification?
1. The notification clarifies that for doing the third-party testing, FSSAI will use the financial year as the year of calculation, and April to September and October to March end are the six months during which six monthly tests are to be done.
2. It is clarified that, as uploading the six-monthly reports is mandatory, for the ease with which FBO can submit the yearly return, the timeline has been extended as follows:For the period of April 1, 2022, to September 30, 2022, the timeline to upload the report is March 31, 2023. For the period of 1 October 2022 to 31 March 2023, it is 30 April 2023, and for the period of 1 April 2023 to 30 September 2023, it is 31 October 2023.
3.As a result, FBOs who did not conduct any testing from April 2022 to September 2022 are unable to submit any report; however, the next six-month testing can be completed prior to 30th March 2023 and uploaded before 30th April 2023.
So, why is it not taken seriously by FBO?
As there is no knowledge of how to do this testing, where should this testing be done? What are the parameters to be tested? Also, many of the products we make are proprietary in nature, so no direct standards are applicable, and we have to do testing as per the nearest possible standards.
A lot of questions come to mind, and we get confused. Here is the short writeup on that.As per this, we need to get the following into practise in our yearly calendar:
Risk analysis and check:
1) We must get a certificate of compliance for each key raw material from the raw material supplier. This is different than the certificate of analysis, which should come with each consignment. The COA is for routine analysis confirmation. A COC—certificate of compliance—is the same as a third-party testing report. As raw material suppliers are also governed by FSSAI, the licence condition is also the same for them. The raw material supplier should give us COC once every six months.
2) COC is a confirmation that said material or product is in accordance with chemical and microbiological parameters, including pesticides, antibiotics, heavy metals, and microbiological parameters.
3) We might buy raw material from a trader, but we might face the problem that the trader might not give a COC, so we might need to ask the original manufacturer for one. However, this is a long process; if we all push, all our raw material suppliers will be forced to give COC.
4) We need to do a risk analysis of the finished product for the following:
1. A) Ingredients—to understand which ingredient we add
2. B) Colours—to understand which colour we add
3. C) Flavours
4. D) Previous test results and if there is any non-compliance: Previous results, if any, should be reviewed for compliance. If we have a history of no non-compliance, then we should convey the same to FSSAI that we are reducing the testing of various products. Refer Finished product risk analysis
5) Once we do a risk analysis and also get the COC from the key raw material supplier, we can do a risk analysis further as follows:
1. A) Conduct an ingredient analysis of the finished product and understand which product has which ingredient (e.g.,)Then confirm whether we have received a Certificate of Compliance for key raw materials.
For example, if we receive COC for besan, oil, and key spices, then we can assume that the bhujiya we make is also compliant with the standards of FSSAI, unless any specific parameters are set. However, we don’t make one product, and hence it is advisable to get the ingredients for each product noted and do a risk analysis as follows:
Risk Analysis of the Finished Product
If we make 5 different varieties of Bhujiya, where the above raw material remains the same but some additions or spice changes are made, for example:
Plain Bhujiya: Besan, Water, Oil, and AjwainSpicy Bhujiya: Besan, Water, Oil, Ajwain, Chilli PowderSpicy Garlic Bhujiya: Besan, water, oil, ajwain, chilli powder, garlicThen we should get the analysis of spicy garlic bhujiya tested against FSSAI standards, and then we can show to FSSAI that the third product contains all the ingredients in the first two products, and hence if the third product is complying with test parameters, then automatically the first two are compliant, as the basic ingredients remain the same.
If we don’t have the above COC for individual raw materials, then we need to get the product tested against parameters as per FSSAI’s above-mentioned risk analysis.
Historical Data Analysis:
We need to do a review of all historical data analysis (third-party test reports from third parties/self-NABL accredited/FSSAI-notified labs). If we have historical data, we can either reduce the frequency of product testing or replace the product with another.
For example, if we have made the following soanpapdi flavours:
1) Orange-flavoured Soanpapdi
2) Plain Soanpapdi
3) Mango-flavoured Soanpapdi
4) Kesar-flavoured Soanpapdi
5) Cardamom Soanpapdi
As there is only one flavour used for orange or mango, kesar, or cardamom, and we have historical results for these flavours as well as other raw materials, we can send orange in the March to October period and mango in the October to March period and avoid sending all 5 samples for testing.
Action in case we don’t do this testing and uploading?
This is a licence requirement and must be met, and compliance must be done anyhow. However, if we have not conducted any analysis between April 1, 2022, and September 30, 2022, we will not be able to upload any testing analysis report.
As far as I understand from government sources (please note that this cannot be confirmed), they will first get the details as to who has uploaded the reports and who is not. Based on that, they might serve notice to explain why the test report has not been uploaded or might visit the facility, but severe action may not be taken the first time.
If we decide to get the sample analysis done from April 2023 onwards, we can provide, as an example, that we have not done the analysis in the past but are willing to do so now.
Way out for this? –
As this is a notification done by FSSAI to enlighten or educate FBOs, there is a likelihood of getting improvement notices or visits in case there is no such testing report uploaded, but nothing can be confirmed as everything officials are sharing is verbal and not confirmed.
It’s better to get the analysis of our food products done prior to March 31 for the period of October 1, 2023, to March 31, 2023, and upload the report prior to April 30. However, it’s a too short time, so the FSNM Regulatory Team might need to send a letter to FSSAI about the short duration notice and giving us six months’ time to comply with the requirement.
What is in Our Hands:
We can at least get the risk analysis done and send the finished product samples at the earliest (at least a few of them if not all ) and get the analysis report.
Also follow up with our raw material supplier to obtain their COC report, which is the basis of a basic risk analysis, and thus we will be improving compliance with the COA and COC from our raw material supplier.
Kindly note that this is a suggestive write-up and not a legal document. Viewer’s discretion is required, and in case of query or doubt, kindly call the FSNM Food Regulatory Team for help.