Food Safety and Standards (Alcoholic Beverages Standards) Regulations, 2016

fss-alcoholic-beverages-standards-regulations-2016The Food Safety and Standards Authority of India (FSSAI) has issued a set of draft regulations being the Food Safety and Standards (Alcoholic Beverages Standards) Regulations, 2016, dated September 5, 2016 and published in the Official Gazette on September 6, 2016.

The FSSAI through the draft regulations intends to regulate both distilled and un-distilled alcoholic beverages such as brandy, beer, rum, vodka, whisky, wines, etc. The FSSAI has invited comments and suggestions on the draft regulations to be sent to it within a period of 30 (thirty) days from September 6, 2016.

The FSSAI by issuing regulations in relation to alcoholic beverages and setting out standards for the same has brought such beverages within the ambit of “food” in terms of the Food Safety and Standards Act, 2006 (FSSA). It will be interesting now to wait for the final regulations and standards to be issued by the FSSAI and also to understand the manner in which the FSSAI would enforce the regulations, as there have not been specific regulations governing alcoholic beverages in the past whether the Prevention of Food Adulteration Act, 1954 or the FSSA.

 

Minimum Area of the Principal Display Panel – FSSA or Legal Metrology

Legal  MetrologyThe term ‘principal display panel’, very simply put, is that panel of a package on which all the label declarations, as required, must be set out, for the information and use of the consumer.

The FSSAI, in terms of the Food Safety and Standards (Packaging and Labelling) Regulations, 2011, requires the principal display panel of all food products to be of a minimum size. The details of the size and other requirements have been set out in the Packaging and Labelling Regulations. However, the Department of Legal Metrology, which also requires certain information to be set out on the principal display panel of packages, does not require the said principal display panel to be of a minimum size. As a result, the food industry has been complying with the requirements in relation to the minimum area of the principal display panel, as per the provisions of the Packaging and Labelling Regulations.

A recent amendment to the Legal Metrology (Packaged Commodities) Rules, 2011 has introduced a provision, in terms of Rule 7(5), which deals with the manner in which the area of the principal display panel is to be calculated, for the purposes of determining the height of the lettering of the label declarations. This has caused a considerable amount of confusion in the food industry, with some taking an interpretation that the Department of Legal Metrology has prescribed a ‘minimum area’ to be maintained, in relation to the principal display panel.

We however tend to disagree with the interpretation that a ‘minimum area’ for the principal display panel is required to be maintained, in terms of the Packaged Commodities Rules. First, it must be noted that this new sub-rule has been set out in Rule 7, which primarily relates to the minimum height of the letters and numerals required to be set out in various declarations. Second, the new sub-rule, no where states that the minimum area of the principal display panel must be as per the method set out therein. Rule 7(5) merely states that area of the principal display panel must be calculated and decided in the manner set out therein.

A careful reading of Rule 7 indicates that the Department of Legal Metrology has set out a formula, based on which the height of numerals is required to be calculated for various declarations. Rule 7(3) in Table II sets out the manner in which the height of numerals is required to be calculated in the event that the net quantity of a particular product is set out in length, area or number. In such cases, the minimum height of the numerals, in the various declarations, is dependent on the area of the principal display panel. This concept of ‘area of the principal display panel’ was earlier not set out anywhere in the Packaged Commodities Rules and therefore led to confusion in compliance. The Department of Legal Metrology, therefore, to clarify the said concept and to set out the manner in which the same is required to be calculated and determined, introduced sub-rule (5) to Rule 7, which merely states the manner in which the area of the principal display panel must be calculated and determined.

To conclude, in our view, the Department of Legal Metrology has not prescribed a minimum area of the principal display panel but has instead clarified the manner in which the height of numerals is required to be set out, in relation to those products where the net quantity is set out in area, length or number. The minimum area of the principal display panel would continue to be governed by the Packaging and Labelling Regulations.

Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011


The Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 have been amended, with effect from August 26, 2016, in relation to the radiation of food products.

The Food Products Standards Regulations, in terms of Regulation 2.13, set out the details in relation to irradiation of food such as the dose of irradiation, the products that could be subjected to irradiation etc. The amendment now has the effect of substituting the entire regulation and new provisions have been set out in relation to the radiation of food products.

Interestingly, the provisions in the Food Products Standards Regulations also set out the specific manner in which certain label declarations are required to be set out on such packages of food. The appropriate and consequent amendments have been made to the Packaging and Labelling Regulations removing the earlier details set out in relation to the labelling of food that has been subjected to radiation.

Food Safety and Standards (Prohibition and Restriction On Sales) Regulations, 2011

Fruits

The Food Safety and Standards (Prohibition and Restriction on Sales) Regulations, 2011 has, with effect from August 26, 2016, been amended in relation to the prohibition of the use of carbide gas in the ripening of fruits and the manner in which blended edible vegetable oils may be sold.

The Prohibition Regulations have always prohibited the use of acetylene gas (commonly known as Carbide Gas) to artificially ripen fruits. The recent amendment to the Prohibition Regulations now permits fruits to be artificially ripened by the use of Ethylene Gas, however at a concentration of up to 100 ppm (100μl/L), depending upon the particular crop, the variety and the maturity.

In addition to the above, the Prohibition Regulations used to mandate that blended edible vegetable oil must be sold in sealed packages, with a volume of not more than 15 litres. The Regulations now have been amended whereby edible blended vegetable oil, whilst still being in sealed packages, be sold in quantities which must not exceed 15 kilograms.

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.

The New Plastic Rules – An Introduction

A new set of rules that could have various implications on the Indian food industry are the Plastic Waste Management Rules, 2016 which have been introduced and brought into force and effect during March this year, by the Ministry of Environment, Forest and Climate Change.

The new Plastic Rules supersede the Plastic Waste (Management and Handling) Rules, 2011. The Ministry has explained that the reason for the supersession is that the Government of India intends to provide and ensure a better framework for the management of plastic waste which is generated in India and to also reduce the amount of plastic waste that is being generated.

The Plastic Rules while introducing certain new concepts, with the intention of bringing about more regulation and also better managing the plastic waste being generated, also changes certain concepts and requirements that were present in the earlier Plastic Rules. One such significant change that has been introduced by the Plastic Rules is in relation to the thickness required to be maintained in relation to plastic carry bags. The earlier Plastic Rules prescribed a minimum thickness of 40 microns while the present Plastic Rules mandate a minimum of 50 microns. Further, the requirement to maintain the minimum thickness has also been extended to plastic sheets and covers made from plastic sheets. The Plastic Rules, have, however, provided an exception with compliance with the minimum thickness in cases where such thickness affects the functionality of the product.

The Plastic Rules now place more responsibility on local bodies and gram panchayats to ensure proper waste collection as well as treatment and disposal of plastic waste. The Plastic Rules also encourage waste generators, which includes any person generating plastic waste, to minimise the generation of plastic waste and to also segregate the plastic waste in accordance with the various rules that have been prescribed.

While there appear to be certain discrepancies and inconsistencies in the Plastic Rules, especially in relation to the registration requirements prescribed for various categories of persons, the introduction of the Plastic Rules is a step forward in minimising the plastic waste being generated in India. In addition, certain states are also taking up the matter more seriously by introducing a complete ban on the use of plastic items such as carry bags, spoons, plates, etc. One such state is the State of Karnataka which, in terms of a Notification dated March 11, 2016, imposed a complete ban on the manufacture and use of various kinds of plastic items such as cups, plates, spoons, banners, etc.

The Plastic Rules would have a considerable impact on the Indian food industry being one of the largest consumers of plastic material. The Plastic Rules, while keeping in mind its objective of better management of plastic waste being generated, has increased the obligations of manufacturers as well as users of plastic materials such as multilayered packaging material.

This write up is intended to provide a brief introduction to the Plastic Waste Management Rules, 2016. This write up will be followed by a more detailed one which will set out the discrepancies and inconsistencies present in the Plastic Rules as well as the increased obligations being placed on manufacturers and users of plastic materials. 

FSSAI – Enforcement Drive on Packaged Drinking Water

Packaged drinking water, or bottled water in common parlance, is among the most regulated products in India. Justifiably so, given that water, a basic essential could cause untold damage if it is not fit for human consumption. The Indian government has therefore mandated that the products of packaged drinking water must comply with the standards prescribed both by the Food Safety and Standards Authority of India and the Bureau of Indian Standards. Accordingly, packaged drinking water can only be manufactured and sold in compliance with the standards prescribed under the Food Safety and Standards Act, 2006 and under the certification mark of the BIS.

The BIS is a body which sets out standards in relation to various products and encourages such products to comply with the standards. A product with the BIS certification mark on it, only instils additional confidence in a consumer. It is also relevant to note that the standards prescribed by the BIS are voluntary, unless made specifically mandatory for certain products, as has been done in the case of packaged drinking water.

The FSSAI, not too long ago, issued an order in relation to bottling plants, manufacturing and selling ‘packaged drinking water’ in an unauthorised manner. The FSSAI had received multiple complaints that these concerned units have not obtained the appropriate licenses under the FSSA and the certifications from the BIS in terms of the Bureau of Indian Standards Act, 1986 (proposed to be repealed by the Bureau of Indian Standards Act, 2016).

The FSSAI has, based on the various complaints made, been undertaking the required checks in relation to water bottling plants and has, during the last week, issued a press release stating that the products of Aquafina, Kinley and Bisleri are being manufactured with the appropriate licenses and certification under the FSSA and the BIS. The press note also states that such checks would continue, in relation to other water bottling plants, to ensure the availability of safe packaged drinking water.

FSSAI Notice – Use of Food Additives

The Food Safety and Standards Authority of India has issued a notice on its website, on June 20, 2016, in relation to the operationalisation of standards of food additives for use in various food categories. This Notice seeks to substitute Regulation 3.1 of and Appendix A to the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 and has to now be complied with in relation to all food products. The FSSAI has indicated that the Notice is required to be complied with till such time that appropriate amendments are made to the Standards Regulations in relation to the use of food additives. In addition, subsequent to the issue of the Notice, the FSSAI has also issued an order in terms of which it has directed all enforcement officials to implement the provisions of the Notice.

The FSSAI now requires food business operators to determine the food additives, which may be used in food products, on the basis of the details set out in the Notice. Notwithstanding this, the FSSAI has, interestingly enough, stated that all current provisions in relation to food additives, in relation to standardised food products, as set out in the standards in the Standards Regulations, would be suspended (except standards for foods for infant nutrition).

The uncertainties that now arise is whether, firstly, the FSSAI intends to suspend only those provisions which specifically permit the usage of food additives in specific food products, or also such provisions, set out in the specific standards, which expressly prohibit the usage of food additives in such food products; and, secondly, whether food products, in relation to which food additives were neither expressly permitted nor prohibited, may now contain such food additives.

A possible way of looking at this would be that all standardized food products may contain food additives, whether permitted or prohibited by the specific standards, provided that the food additives to be used are as permitted for that food category, in terms of the Notice. Further, those products for which nothing expressly was stated may also contain the permitted food additives. The flip side to this, however, would be that the scope of standardized food products would be altered in its entirety, which in all probability is not what the FSSAI intended.

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.

Memorandum of Understanding – FSSAI & The Advertising Standards Council of India

The Food Safety and Standards Authority of India and the Advertising Standards Council of India, a self regulatory body committed towards protecting the legitimate interests of consumers, have recently signed a memorandum of understanding, to track and report misleading advertisements.

In terms of a press release, the FSSAI has stated that the ASCI would be able to take up and process consumer complaints in relation to misleading advertisements. In case of any non-compliance with the recommendations of the ASCI, based on its findings, the ASCI would report such non-compliance to the FSSAI, who would in turn take appropriate action against such food business operator under the Food Safety and Standards Act, 2006.

The alliance between the FSSAI and the ASCI should definitely bring about professionalism in relation to evaluation of advertisements, given that the ASCI comprises of members of high repute from the advertising industry. The ASCI, has so far had an impressive track record and a positive impact, in relation to misleading advertising, with more than a majority of advertisers having modified or withdrawn their advertisements, pursuant to complaints against such advertisements being upheld by the ASCI.

The memorandum of understanding, however, does not address the action that may be taken by the FSSAI against misleading advertisements, whether withdrawn or modified, based on the decisions of the ASCI. The FSSA clearly prohibits advertising of food products which are misleading or deceiving and a violation would result in the penalties set out there under. Thus, it may be concluded that the violation of the FSSA in relation to misleading advertisements would not be condoned by withdrawing or modifying the advertisement based on a decision of the ASCI.