Tag Archives: Proprietary Food Products

Licenses for Proprietary Food

The Food Safety and Standards Authority of India (FSSAI) has now set out the meaning and standards for proprietary food products very clearly in the regulations. The FSSAI has, however, not set out the resultant implications in relation to the issue of licenses required for the manufacture of such products.

Proprietary food products, as a concept, have been in existence even prior to the Food Safety and Standards Act, 2006 (FSSA) being brought into force and effect.

An obvious implication of the new meaning and standards for proprietary food products, that were set out by the FSSAI, was the requirement for food business operators to re-evaluate each of their products and ascertain as to whether they continue to remain proprietary. The FSSAI, however, did not require, by way of any law or order, for these food business operators to reapply or make any changes in relation to the license for the manufacture of the products, if they continued to be proprietary food products.

The FSSAI, has now, recently updated the online licensing system and has set out a separate category for proprietary food products, novel foods, etc. This is an excellent move by the FSSAI as now there is a clear and express route that can be used for applying for a license in relation to the different kinds of food products. The FSSAI, however, did not make any provision for those food products that were granted licenses prior to the online licensing system being updated, nor did the FSSAI provide any clarity for those food business operators who had licenses issued for products, prior to the new meaning and standards being introduced, and which products continued to be proprietary under the new law.

The FSSAI, however, now requires that these issued license holders approach the FSSAI and apply for a modification of their licenses for the reason that the proprietary food products being manufactured are not under the category as required by the updated licensing system and the FSSAI as on today. Whilst there is no order or communication in this regard, food business operators find this being required of them on approaching the FSSAI for modification of their license to include additional products or additional food business activities or while applying for a renewal of their licenses.

The above seems rather unfair to food business operators who are required to make an application for the modification of their licenses and also pay an additional fee in view of a delay on the part of the FSSAI in updating the online licensing system or in providing clarity on the matter. While the intention of the FSSAI cannot be questioned, it should take this particular matter into consideration and and consider it fair to provide a solution to these food business operators or a more efficient manner in which their licenses could be updated.

Proprietary Food – The Final Regulations

In a previous post, we had discussed a direction issued by the Food Safety and Standards Authority of India, in August this year, in relation to the ‘finalised standards’ for proprietary food products. The post, among other things, discussed the gaps in the direction, specifically in relation to whether the same was enforceable and was issued by the FSSAI in accordance with the procedure and requirements of the Food Safety and Standards Act, 2006.

The FSSAI has now, as on October 13, 2016, issued a final notification which amends the provisions set out in the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, which specifically sets out the meaning and standards for proprietary food products. These provisions will now be the final provisions that would apply to proprietary food products and would supersede earlier notifications, orders and directions issued by the FSSAI.

The provisions of this notification are the same as compared to the earlier direction issued by the FSSAI, with the exception of the provisions in relation to health claims. While the earlier direction prohibited all types of health claims to be made in relation to the products, whether on the label or otherwise, this notification now permits health claims to be made, whether on the product label or otherwise, as long as the same is substantiated with adequate and scientific evidence.

The above change made by the FSSAI to the regulations as were set out in the direction, comes as a welcome relief to the food industry. As we had stated earlier, it did not seem logical as to why the FSSAI was preventing such food products from making health claims while the main Act, the FSS Act, itself permits such health claims, as long as the same are capable of being substantiated with adequate and scientific evidence. It appears that the FSSAI has now kept the final regulations in tune and in line with the main Act, the FSS Act.

In addition to the above, while this notification states that the final regulations and provisions would come into force on the date of the publication in the Official Gazette, i.e. October 13, 2016, it appears that the FSSAI has provided time to food business operators to comply with the same until July 1, 2017. This would, in our view, imply that the enforcement activities in relation to proprietary food products complying with these regulations would be undertaken only subsequent to July 1, 2017.

Finalised Standards – Proprietary Food

In an earlier post we had dealt with the ‘Corrigendum to the FAQs on Proprietary Food Products’, wherein the Food Safety and Standards Authority of India had replaced certain provisions contained in a set of FAQs, which were used by the FSSAI to patch up the new standards for proprietary food products, earlier introduced in terms of a notification during January 2016. The FSSAI has now, in terms of a direction dated August 22, 2016, issued what they term as ‘finalised standards’ in relation to proprietary food products.

It is interesting to note that the standards set out in terms of the January notification were valid only for a period of six months, i.e., till July 15, 2016. If a straightforward interpretation of the provisions of the Food Safety and Standards Act, 2006 is to be taken, then there were no revised standards for proprietary food products for the period between July 15, 2016 till August 22, 2016 and the provisions as were initially contained in the Food Standards Regulations would apply. It must be noted that the original standards are much broader in scope as compared to the standards that the FSSAI has evolved. However, one could also argue that as on date there are no new standards and the original standards continue to apply, in view of the questionable manner in which the direction has been issued (discussed in detail below).

As the standards set out in the January notification were valid only till July 15, 2016, the FSSAI issued a set of draft regulations, which contained the new standards. The draft regulations were issued by the FSSAI following the proper procedure in terms of the Food Safety Act and proposed to amend the Food Standards Regulations (i.e. the regulations which set out the initial standards for proprietary food). The FSSAI invited comments and suggestions from the public, in relation to this draft and the same was to be provided by May 27, 2016.

The FSSAI should have ideally issued the regulations amending the Food Standards Regulations, after considering the comments and suggestions. However, neither was any amending regulations issued, nor was any clarity provided by the FSSAI in this regard.

In an attempt to plug the gap mentioned above, the FSSAI has issued the direction on August 22, 2016, in terms of which it has stated that it has now finalised the standards in relation to proprietary food products and is making the same operational on and from August 22, 2016. These finalised standards have been enclosed with the direction issued by the FSSAI and all enforcement officers have been instructed to enforce these new standards. The FSSAI has stated that it is in the process of issuing the final notification in terms of which it would amend the Food Standards Regulations.

The finalised standards issued by the FSSAI, are a mix of the earlier standards issued in terms of the January notification, the FAQs, and we presume, the comments and suggestions received by the FSSAI on the draft regulations. While most of the provisions are similar to the ones set out in the earlier standards and the FAQs, one drastic change that the FSSAI has introduced is in relation to ‘health claims’. As mentioned in our earlier post, the FSSAI had prevented food products that contained added vitamins and minerals from making any health claims. This, we felt, was clearly against the other provisions of the FSSA, for the reasons earlier stated by us.

The FSSAI has now gone a step ahead and has stated that all proprietary food products are not permitted to make any health claims whatsoever, and the same is not related to the use or addition of vitamins and minerals. One can now only wonder why the FSSAI has gone so far in restricting the use of scientifically substantiated health claims which is otherwise permitted by the FSSA and the regulations made thereunder.

In our view, and from a legal perspective, the finalised standards issued by the FSSAI as a ‘direction’ seeks to direct enforcement officers to enforce the finalised standards as set out in the direction. The question that now arises is whether these finalised standards, in the absence of a final notification, could be enforced given that such finalised standards could only be brought in by amending the Food Standards Regulations, through the due process of law.

Corrigendum to the FAQs on Proprietary Food Products

The FSSAI, during January 2016, brought about certain changes to the meaning and standards of “proprietary food products”, in terms of an amendment to the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011. Subsequently, during March 2016, the FSSAI published a set of FAQs, on its website, in relation to proprietary foods, with the intention of providing certain clarifications on the meaning of the same. However, in addition to providing the clarifications, the FSSAI, through the FAQs, set out certain additional standards for proprietary food, such as in relation to the ingredients, food additives, etc., that may be used in the same. The position on proprietary foods was further complicated when the FSSAI, during the month of June 2016, issued a corrigendum in relation to the FAQ set out in relation to the kinds of ingredients that may be used in proprietary foods.

The corrigendum has the effect of providing that the addition of vitamins and minerals to proprietary foods may be allowed, up to a level of 100% of the Recommended Daily Allowance, provided there is no health claim on the label.

The Food Safety and Standards Act, 2006, mandates that the labels of food products shall not contain any statement or claim, concerning the food product, which is false or misleading. The same is reflected in the Food Safety and Standards (Packaging and Labelling) Regulations, 2011. In the absence of any specific prohibition, the obvious corollary is that a label may contain claims or statements, concerning the food product, so long as it is not false or misleading. This is an accepted industry practice since time immemorial and it would appear absolutely illogical to prevent a manufacturer from setting out any health related claims or benefits, for the information of consumers. Further, the FSSAI also requires such claims, if being made, to be capable of being substantiated with appropriate scientific evidence and places the onus of making true and scientifically sound claims on the person making the claim.This further questions the approach being taken by the FSSAI, by way of the corrigendum, where it is attempting to prohibit operators from making claims.

The question that now arises is whether a food business operator is bound to follow such an unreasonable direction issued by the FSSAI, which is against the provisions of the FSSA itself. Probably not, is what we would feel. The legality of these additional provisions in the FAQs and the corrigendum is highly questionable in view of the fact that the FSSAI has not followed the due procedure, as prescribed in the FSSA in relation to introducing the new provisions as set out therein. It is not very long ago that the Supreme Court in the Vital Nutraceuticals case struck down the FSSAI’s product approval process as being invalid and without the force of law, as the entire product approval mechanism was put together through advisories, clarifications and FAQ’s issued by the FSSAI, without following the due procedure.