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Impact of FSS Schedule 4 on the beverage industry
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Tuesday, 01 October, 2013, 08 : 00 AM [IST]
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Udai K Saxena
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fiogf49gjkf0d Right since the enforcement of the Food Safety and Standards Act, 2006, on August 5, 2011, in the country, a fresh scenario has emerged with regards to food safety requirements. Since then emphasis has been put on various food safety and hygiene requirements and has been incorporated as mandatory requirements for any Food Business Operator (FBO) operating in the country in any capacity.
The FBOs need to adhere to these very stringent though simple-to-adapt requirements with specific reference to the type of industry and nature of operations as elaborated in Schedule 4 of Food Safety and Standard (Licensing and Registration) Regulations, 2011.
There are generic requirements for all FBOs falling under licensing, whether state or Central, under Part 2 of the Schedule 4. Although the entire food chain excluding pre-harvest is impacted with the Schedule 4 requirements but the degree of impact varies depending upon the sector that is applicable.
With specific reference to the beverage industry, which includes the following under current food codes, the present article analyses the requirements, which have significant impact, if not interpreted and implied true to the spirit.
14 – Beverage (Excluding Dairy Based Beverages - 1.1.2) (Level 1)
14.1 – Non-Alcoholic (Soft Beverages) (Level 2)
(Level 3)
14.1.1 Waters
14.1.2 Fruit & Vegetable Juices (including Concentrates)
14.1.3 Fruit & Vegetable Nectars (including Concentrates)
14.1.4 Water-based flavoured drinks, including "sport," “energy,” or "electrolyte" drinks and particulated drinks, water-based drinks (non-flavoured)
14.1.5 Coffee, coffee substitutes, tea, mates, herbal infusions, and other cereals and grain beverages, excluding cocoa
14.2 – Alcoholic beverages, including alcohol-free and low-alcoholic counterparts (Level 2)
(Level 3)
14.2.1 Beer and malt beverages
14.2.2 Cider and perry
14.2.3 Grape wines
14.2.4 Wines (other than grape)
14.2.5 Mead
14.2.6. Distilled spirituous beverages containing more than 15% alcohol
14.2.7 Aromatised alcoholic beverages (e.g., beer, wine and spirituous cooler-type beverages, low-alcoholic refreshers)
(All these are further classified under Sub-category to Xxxx (Level 4)
1.1.2 Dairy-based drinks - flavoured and / or fermented (e.g., chocolate milk, cocoa, eggnog, drinking yoghurt, whey-based drinks)
The Schedule 4 Part II has specified requirements under 12 sections
1 Location and surroundings
2 Layout and design of food establishment premises
3 Equipment & containers
4 Facilities
4.1 Water Supply
4.2 Cleaning utensils and equipments
4.3 Washing of raw materials
4.4 Ice and Steam
4.5 Drainage and waste disposal
4.6 Personnel facilities and toilets
4.7 Air Quality and Ventilation
4.8 Lighting
5 Food operations and controls
5.1 Procurement of raw materials
5.2 Storage of raw materials and food
5.3 Food processing / preparation, packaging and distribution / service
5.4 Food packaging
5.5 Food distribution and service
6 Management and supervision
7 Food testing facilities
8 Audit, documentation and records
9 Sanitation and maintenance of establishment premises
9.1 Cleaning and maintenance
9.2 Pest control systems
10 Personal hygiene
10.1 Health status
10.2 Personnel cleanliness
10.3 Visitors
11 Product information and consumer awareness
12 Training
In case of beverage industries, all the requirements are to be met as specified under each section, but here those areas are discussed in detail, which has more impact on product safety and quality of beverages. These are general deliberations and may vary even within the beverage sector.
1. Locating and surrounding – These can play an important role in cross contamination because the major biological concerns are yeast and mould, which can grow easily in any condition. This requires careful evaluation of surroundings and providing with all measures which might be required to be provided based on risk analysis and available preventive measures
2. Layout and design of food establishment premises - As the beverage industry is liquid and sugar-based, the design of the premises should be such that it can handle appropriate quantity of water / liquid and the drains etc. should be capable of preventing backflow from low risk areas to high risk areas within the facility. Stagnation of the wash water can be a biggest issue as it will contain residual sugar and other nutrients giving suitable conditions for microbial growth. The wall floor and roof should also be such so that powdery material if stuck can be cleaned easily. Cracks and crevices can provide breeding and harborage place for pests. The floors in particular should have proper slope and non-reactive to acids. Machines placement should be such that thorough cleaning is possible. There may be many more risk-based issues, which need to be addressed for ensuring food safety.
3. Equipment & containers - Due to use of various ingredients and additives in the beverage industry, selection of construction material for equipments, containers and food contact surfaces materials used for product contact must have adequate strength over a wide temperature range, a reasonable life, be non-tainting, corrosion- and abrasion-resistant, easily cleaned and capable of being shaped. Stainless steel usually meets all these requirements. The material should be such which is non-reactive (food safe) or in other words inert, so that migration of the construction material does not take place due to reaction with ingredients and additives. The design should facilitate complete draining and cleaning as per requirement. No dead ends are there in containers and vessels used for preparation of syrups and so on. It is also possible that same grade of food safe material may not be suitable for all types of products manufactured e.g. SS used for vessel handling less acidic product and highly acidic products should be of different grades i.e. there are various grades of stainless steel which can be selected for their particular properties to meet differing operational requirements, e.g. Type 316 which contains molybdenum and is used where improved corrosion resistance is necessary.
Bearings should, wherever possible be mounted outside the product area to avoid possible contamination of product by lubricants (unless they are edible), or to avoid possible failure of the bearings due to the ingress of the product. Shaft seals must be designed in such a way that they are easily cleaned. If they are not lubricated by the product, then the lubricant used must be edible. Where a bearing is within the product area such as a foot bearing for an agitator shaft in a vessel, it is important that there is a groove completely through the bore of the bush from top to bottom to permit the passage of cleaning fluid. Doors, covers and panels should be designed so that they prevent the entry of and / or prevent the accumulation of soil, where appropriate they should be sloped to an outside edge and should be easily removed to facilitate cleaning. All pipelines and equipment surfaces should be self-draining, because residual liquids can lead to microbial growth or, in the case of cleaning fluids, result in contamination of product.
4. Facility – The beverage industry has intensive use of water and water-based ingredients hence monitoring of water quality should be more stringent. The water quantity and quality should be appropriate to the use e.g. as ingredient, for cleaning and washing equipments and contact surfaces and general cleaning, hand-washing and so on. A small deviation can cause unimaginable cross contamination leading to major crisis hence water safety and quality needs special care and caution always. Similarly gases used in flushing and packing and as an ingredient in beverages, need to be continuously checked for its safety and quality. Ambient air monitoring is also essential. Ice and steam if used in direct contact must be food grade / culinary to ensure product safety. All chemicals used in boilers to produce steam used for direct injection should be certified food grade. Facility should have adequate and effective ventilation to prevent cross contamination. Exhaust fans and air curtain should be kept in good working condition so that the purpose of installing these based on risk analysis is not defeated. Lighting plays an important role in ensuring safety and quality of beverage. Adequate lighting is needed to ensure visual checking of product and defects in filled containers like glass bottles, hence proper selection of light source is necessary. In case of view glasses where light bulbs are installed these should be burst-proof and covered. The fittings and fixtures for lighting should be such which ensures food safety.
5. Food operations and control - This is heart of all requirements hence very clear and precise procedures should be laid down for procurement, storage and distribution of raw material, packaging material and finished goods. As most of the ingredients are of agro-based hence emphasis should be laid on pesticide residue and microbial safety because of the nature of these items. The documentary evidences of the safety and quality analysis should be maintained either as CoA (Certificate of Analysis) or CoC (Certificate of Conformance). Standards and specification for various items should be as per stipulated requirements based on potential risk imposed through these and as per regulatory requirements for the beverage sector. Demonstration of compliance to these regulatory requirements should be available with the FBO at any point of time. The storage capacity for raw, semi-processed and processed product as well as for packaging material and finished goods should be in accordance to the companies stock policy and installed capacity mentioned in the licence issued by FSSAI.
6. Management and supervision – There are certain mandatory requirements, wherein FBO need to have written policies and procedures. The availability and then adherence to these at all times is a must requirement. This provides as objective evidence to the management commitment to food safety. Even the corporate / head office must demonstrate that how they exercised controls on their units.
7. Food testing facility – The food testing requirements need to be established and if not available in-house then must be outsourced to the FSSAI approved NABL (National Accreditation Board for Testing and Calibration Laboratories) accredited labs as per set frequency.
It will be advisable if a formal contract is entered with such lab/s and necessary documentation should be available. One should ensure that all outsourced test should be conducted as per set frequency to ensure food safety at all times and also only those labs should be selected whose NABL scope covers the desired tests.
8. Audit, documentation and records – The Schedule 4 also stipulates under Audit, Documentation and Records that “A periodic audit of the whole system according to the SOP shall be done to find out any fault / gap in the GMP / GHP system.” This implies that FBO must have a Standard Operating Procedure (SOP) and Internal Audit shall be conducted as per this to ensure overall performance of the system. It seems very simple to implement the requirements of any system. Initially, all efforts are put to achieve the goal for food safety system implementation by the team with requisite resources provided by management. However the periodic evaluation of the system is necessary to ensure that system is maintained and improved continuously. In order to achieve it effectively, the internal audit is an important tool available with the management for continual improvement and to manage any emerging risk evolving during the working of the system. The findings of internal audits should be treated as an essential input for the management review and should never be treated as mere formality for fulfillment of system requirements. Retention of record should be done minimum for the period of one year or upto the shelf life of products manufactured, whichever is more.
9. Sanitation and maintenance of establishment premises - In case of the beverage industry cleaning and sanitation has greater impact and importance to prevent cross contamination and maintain product quality. CIP (Clean In Place) plays an important role in ensuring food safety and quality in the beverage industry due to handling various products in same facility using shared equipments, which may lead to cross contamination and flavour crossovers. Further if facility is not maintained then it can lead to growth of microbes, yeast and moulds and entry and pest harborage specially house flies. Preventive maintenance of entire facility plays and important role in ensuring compliance to this requirement of Schedule 4. Maintaining necessary records is necessary to `show evidence and facilitate root cause analysis in case of any adverse incident involving food safety.
Pest management being outsourced activity in most cases should be monitored more precisely with the records of treatments, chemicals used, pest proofing measures used and trend analysis of pest citing.’
10. Personal hygiene – It is a well-known fact that personal hygiene is treated at par with other key requirements and that is true for the beverage industry as well. As per Schedule 4 requirements, periodic medical check-up and vaccination of food-handlers and all persons involved in food handling is must. Medical condition reporting policy of food-handlers should be available apart for visitor health declarations. It will be advisable if access control is provided for high-risk areas, such as processing and packaging for effective control and prevention of cross contamination. In case of the beverage industry more emphasis is needed on the cleanliness of work wear and personal protective gears. A set policy for cleaning of work wear and discarding of single-use items like caps, masks, and gloves should be available. The personal hygiene checklist should be developed and implemented based on perceived risk.
11. Product information and consumer awareness – Providing appropriate and accurate information is to be provided to customers and consumers in such a manner that it is not giving false or misleading information about the products, its constituents or benefits provided. Giving false information is also punishable under the regulations and FBO should ensure compliance to the packaging and labelling regulations and also the ingredient and additives regulations to avoid action. Product should be placed in appropriate food category and necessary approval should be sought if it is not a standardised product under FSS Act.
12. Training – Often given a backseat by FBO in any sector, is a highly emphasised requirement under Schedule 4. It requires generic food safety training along with task specific trainings to all concerned. Also seeks retraining, refresher trainings and evaluation of the same. Documentation of training should be available like the exact requirements as per Point 12 of Schedule 4 Part II is given hereunder:
12.1 The food business shall ensure that all food-handlers are aware of their role and responsibility in protecting food from contamination or deterioration. Food-handlers shall have the necessary knowledge and skills which are relevant to food processing / manufacturing, packing, storing and serving so as to ensure the food safety and food quality.
12.2 The food business shall ensure that all the food-handlers are instructed and trained in food hygiene and food safety aspects along with personal hygiene requirements appropriately as per their roles and needs in the organisation.
12.3 Periodic assessments of the effectiveness of training, awareness of safety requirements and competency level shall be made, as well as routine supervision and checks to ensure that food hygiene and food safety procedures are being carried out effectively.
12.4 Training programmes shall be routinely reviewed and updated wherever necessary.
Effective planning for training on food safety
- Type of training – Introductory / orientation / advance / job-specific / refresher training / special purpose training
- Type of participants – Level of skill / shop floor / supervisory / executive / managerial / top management / supplier / distributors / customer / others
- Trainer competency – Desired competency
- Resource person - In-house or outsourced (higher knowledge of subject)
- Duration of training – If more than 2 hours then should have breaks
- Requirements for conducting training – Suitable place (preferred away from working place – if not on job), AV, and others
- Degree of comfort for trainee – full-time devotion / relieve for the training period from routine job
- Effective communication
- Effective evaluation and interpretation of outcome
- Always do effectiveness evaluation of training outcome
- Design the questions in such a way that it takes out result of presence of various skills / attributes of the participants
- Analyse the strong and weak areas of individuals as well as of the entire group
- There will be certain areas where majority will be strong and weak as well
- Try to design next training focussing more on weaker aspects
- Utilise participants skills / attributes in future trainings where they are strong
- If the organisation has group of units then such analysis of individual units will help in identifying strong pockets and utilising inter-unit to strike balance
(The writer is a New Delhi-based food safety and system expert and consultant He can be reached at udai.saxena@gmail.com)
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