CAMS

Complementary & Alternative Medicines

What are Complementary & Alternative Medicines? Complementary and Alternative Medicines (CAMS) are various traditional supplements and treatments that are not considered to be mainstream registered or conventional (allopathic) medicines. Conventional medicines are regulated by the Medicines Control Council (MCC) through Act 101 of 1965. Medicines are regulated under four categories A, B, C and category D. The most crucial requirement of regulating medicines, which now applies to CAMS products (category D) is showing efficacy and safety. Essentially manufacturers must show that the product is safe for consumption and can fulfil its function as claimed, at its intended dosage.

In terms of the guidelines for CAMS, a complementary medicine means “any substance or mixture of substances which a) originates from plants, minerals or animals; b) is used or intended to be used for, or manufactured or sold for use in assisting the innate healing power of a human being or animal to mitigate, modify, alleviate, or prevent illnesses, or the symptoms thereof or abnormal physical or mental state, and c) in accordance with the practice of the professions regulated under the Allied Health Professions Act, 1982 (Act No 63 of 1982).”

What does this mean for manufacturers of food products? The food labelling regulations R. 146 of 2010 (clause 13(g)) prohibit the sale of any foodstuff which bears a medicinal claim, including prophylactic and therapeutic claims. Simply put, a foodstuff bearing any health claim relating to the prevention or treatment of a disease will be regulated as a CAMS product. These include claims relating to diabetes, cancer, blood pressure, osteoporosis, heart disease etc.

What are the requirements for CAMS products? Since 2013, CAMS are now regulated under categories A and D of the Medicines Act (R. 870 of 2013). Category D includes homeopathy, naturopathy, Ayurveda, osteopathy, phytotherapy and aromatherapy. Category A, one of the categories for conventional medicines now includes CAMS medications such as high potency Vitamins.

Labelling for these newly regulated CAMS must comply with the requirements for medicines by February 2014. Registration of various groups of medicines now falling under category D would be called up in batches:

Is your product affected?

March 2014: 20.2.8 Antiviral agents; 21.2 Oral hypoglycaemics (Diabetes); 6 Cardiac medicines; and 26 Cytostatic agents.
November 2015: 32.3 Slimming preparations (weight reduction products); and 7.1, 21.7, 21.8, 21.9 Sexual stimulation products.
May 2016: 32.16 (Other) Immune boosters; 17 Medicines acting on muscular system (body building products); and 22 (Vitamins) Sport supplements containing vitamins and minerals exceeding the upper limit allowed
November 2019: All remaining pharmacological classifications, including products in Category D and other categories.

What is the responsibility of manufacturers of CAMS? All manufacturers and wholesalers of CAMS must now be licenced by the MCC. This registration process is intended to be simplified compared to that of conventional medicines, but must show evidence of safety of the product, as well as appropriate manufacturing standards (Good manufacturing practices) and efficacy. If an applicant cannot provide suitable information to the Council, they must remove the product from the market, until registration with the MCC. Alternatively the product may remain on sale, but no medicinal claim may be made in any published information including advertising, labels and product inserts. By November 2019 the legislation will have come into effect for all complementary medicines affected by R. 870 of 2013.

In addition, the product label, package insert and patient information leaflet of all Category D medications must comply with CAMS labelling requirements. The requirements for CAMS products include that the label must indicate the category and pharmacological classification of the medicine and the discipline (for example homeopathy). In addition if it has not been registered by the MCC it must bear the statement “This medicine has not been evaluated by the Medicines Control Council. This medicine is not intended to diagnose, treat, cure or prevent any disease”.

Then what claims are allowed on “foodstuffs”? Currently only nutrient content claims are permitted on food products. Nutrient content claims are claims regarding the levels of a particular nutrient or energy present in a foodstuff. These include claims relating to fat, carbohydrates, protein, vitamins, minerals etc. These are prescriptive claims and there are strict conditions regarding their use, provided in the regulations.

Phase two of the food labelling regulations which are currently in draft will address nutrient-function claims and disease risk claims, these will be generic statement and include claims such as “Diets low in saturate fat and cholesterol that contain 2 g of plant sterol esters and plant stanol esters daily, may reduce the risk of heart disease by lowering cholesterol” and “vitamin C contributes to normal collagen formation for the normal function of skin”. However, phase two of the regulations has not yet been passed and until such time as they are, such statements will be prohibited on the labelling of foodstuffs.

In summary? Currently any health related claim that is not a nutrient content claim on a food product is prohibited, unless the product complies to the CAMS regulations and is registered with the Medicines control council. CAMS products require that manufacturers produce their product under Good Manufacturing Practice conditions and show safety and efficacy. Additional labelling requirements for CAMS products under Regulation 8 of the Medicines and Related Substances Act, 1965 are also required to be met.

Article by: Gillian de Villiers

Food Safety

Aiming for a Food Safety Management System

Aiming for a Food Safety Management System (FSMS)?

Why would one aim for a Food Safety Certification? The basic South African legal requirement for food production is that a food facility must comply with R962/2012. If it complies with this, and a Health inspector passes the facility and awards a Certificate of Acceptability, then food may be manufactured in the facility. This is needed for all organisations, from the smallest mobile coffee operator, to the largest pre-packaged food manufacturer.

A Food Safety Management System is a tool to manage food safety, quality and legal requirements. While R962 covers the essential legal requirements for a facility, a FSMS assists in managing quality and safety. For many manufacturers the greatest reason to apply for a Food Safety Certification is because of customer demand, particularly from retailers.

All full Food Safety Certifications will require a Food Safety Management System to be implemented. This is essentially a documented Quality Management system that describes everything that is being done on the premises and allows production to conform with all aspects of Food Safety and legality. This includes such elements as “GMP/PRP” Good Manufacturing Practice and Pre-requisite programmes, which all facilities will have, such as cleaning, pest control programmes, allergen management, facility and process layout, training needs, etc. In addition a FSMS will include an analysis of the specific needs and risks associated with your own production process, and how to manage this (HACCP – Hazard Analysis and Critical Control Points). Some more widely known certifications in South Africa are FSA (Food Safety Assessment), FSSC 22000 (ISO Food Safety System) and BRC (British Retail Consortium). FSA has recently become a stepping stone towards an FSSC22000 certification, while both FSSC22000 and BRC are internationally recognised GFSI-based Food Safety Certifications.

It typically takes a client between 6 months to a year to put a full food safety management system in place and be ready for an audit, depending on how available the quality manager/ Food technologist is and how much support they have. We would not recommend a client attempt to put a system in place in under 6 months. To be audit- ready it is necessary to have at least 3 months of documentation history, therefore, they have been manufacturing with most production documents in place for a period of 3 months. Likewise, these timelines also apply to clients going for the GMP basic and foundational level FSA audits. In addition, even once a system has been fully implemented, it will require considerable time and human resources to manage it as with most certifications every document in the system needs to be revised annually, all maintenance and calibration managed, monthly microbiological testing performed and process and HACCP documentation updated whenever a change is made to the production process, and this doesn’t even cover the continuous improvement of the system required by the certification body to show due diligence in food safety.

If a potential client requires a certification before they are prepared to purchase the product, it would make sense to try to find other clients who can buy the product in the period that the organisation is manufacturing but not yet certificated, as it may be between 6 months and a year before certification, or even longer.

Because the Food Safety System is a living system, it is also not possible to audit before manufacture, as the audit needs to demonstrate that all the processes and procedures are being followed (including cleaning, pest control, and the appropriate manufacturing methods). The alternative, which some manufacturers have done, is to negotiate with their retailer to accept their product, while giving evidence that they are working towards a Food Safety Management System and certification. Depending on customer requirements, a manufacturer may manufacture for some time with only the Certificate of Acceptability, before choosing to implement a Management System and be certified. In the interim, to booste small business, some retailers have listed products of small manufacturers on the condition that they undergo and pass a GMP basic or foundational level audit.

In summary, gaining a food safety certification is resource intensive both during the initial implementation, and in its upkeep. Applying for a certification may also be a longer term process than manufacturers originally envision, therefore this should be carefully considered as part of the business case.

Article by: Gillian de Villiers

Hygiene

Hygiene in the Kitchen

How can a kitchen or food factory ensure they are reducing the opportunity for microbial growth?

Cleaning is the process of removing dirt, grease and grime from a surface. Cleaning must be performed on hands, fruits and vegetables, food contact surfaces and non-food contact surfaces.

One of the best ways to prevent food contamination is hand-washing. The WHO recommends hand-washing to prevent disease. To wash your hands properly rub with soap for 20 seconds, rinse, dry with a clean paper towel and then rub with sanitiser and allow the sanitiser to dry (see http://www.who.int /gpsc/5may/How_To_HandWash_Poster.pdf). Hand washing should be performed whenever changing tasks, such as after going to the toilet, after handling rubbish or dirty utensils, after coughing, sneezing, nose-blowing, smoking, eating or drinking, after handling money, when switching between raw and ready-to-eat food and before putting on gloves.

Fruit and vegetables should be cleaned before use with a vegetable wash, or disinfectant such as chlorinated or ozonated water.

A detergent is a chemical that removes residue and grease from a surface, but it does not usually disinfect (kill microbes). A disinfectant chemical is a chemical that can kill most micro-organisms on surfaces, including pathogens (although it may not be able to kill viruses or bacterial and fungal spores). A detergent-disinfectant has the ability to both clean and disinfect. For the food industry, cleaning chemicals must comply with the SANS 1828 requirements, and detergents or detergent- disinfectants with the SANS 1853 requirements.

Food contact surfaces (such as utensils, mixers, containers, chopping boards, work surfaces and production belts) and hand contact surfaces (such as handles of cupboards, freezers, refrigerators, utensils as well as taps and switches) need both cleaning and disinfection. Cleaning materials and equipment also need to be carefully cleaned and disinfected to avoid becoming a source of cross-contamination, use of disposable cloths and paper towels are recommended. It is always necessary to clean before disinfecting, as particles and grease provide areas where microbes can be protected from the disinfectant which is meant to kill them. In order to disinfect, chemicals, steam and hot water (above 82°C) can be used.

After preparing a food, and before preparing the next product, equipment such as cutting boards, utensils, dishes and countertops must be cleaned. To clean, first pre-clean by scraping off large amounts of food and grease particles. Then use detergent to take all the rest of the dirt and grease into the water. Rinse with clean water, disinfect with a chemical disinfectant, then rinse so no disinfectant remains. Or disinfect by submerging a rack of items into hot water (at least 82°C) for 30 seconds. Then air dry and cover the item so it is safe from being contaminated before the next use.

Segregation. The principle of segregation, or separating things from one another, is used to manage a number of risks, including that of physical, chemical and allergen contamination. Segregation is also used to reduce microbiological risks to a product. Separating foods to reduce microbial risk will also apply to storage: raw vegetables should be stored apart from raw meat. It is best to store raw and cooked foods separately in a refrigerator, storing cooked foods above raw foods, so that raw food cannot accidentally fall into and contaminate cooked food. In addition cooked food should not be returned to containers which housed raw food, unless the container was thoroughly cleaned. This is meant to prevent microbial contamination of, for example, cooked chicken by raw chicken. Similarly, a food production environment should be set up in such a way that there is minimal chance for raw materials, work in progress, final product and waste to cross paths, thereby again reducing the opportunity for transfer of microbes between items. One example of this is to use different, colour coded, cutting boards for different foods such as fish, poultry, raw meat, raw vegetables and cooked foods. Therefore separating food prevents transfer of microbes from one food to another, keeping cleaned and/or cooked foods from being exposed to microbes again. Thus, reducing risk of spoilage, and harm to consumers.

Time & Temperature control. Temperature can control microbes in two ways: chilling can slow their growth, and cooking can kill them outright. It is important to keep food cooler or warmer than the temperatures that pathogens (dangerous microbes) grow the fastest, which is from 4°C to 65°C. Therefore, ensure that as soon as foods are received that frozen foods are put in the freezer (below -12°C) and chilled foods are refrigerated (below 4°C). Food must only be defrosted in the refrigerator or under cold running water, and food defrosted with water must be cooked immediately. Similarly always marinate food in a refrigerator. It is important to remember that once a food that was frozen or chilled warms up again, the microbes will grow as fast as ever.

Microbes can be killed by cooking, when food is cooked to the correct internal temperature (the temperature in the very middle of the food, e.g. middle of a chicken breast), or higher. This is because lower temperatures will not be enough to kill microbes. An internal temperature of more than 80°C for more than 10 minutes is generally sufficient, as it will kill Salmonella species, Listeria monocytogenes, Staphylococcus aureus, Enterobacteriaceae, Escherichia coli and Clostridium perfringens (excluding C. perfringens spores). The guidelines above are, however, not appropriate for hermetically sealed foods (e.g. canned products) as they do not reduce the risk of spore-forming bacteria such as Clostridium. For microwave cooking it is important to ensure that cooking is done evenly with no cool areas where microbes could survive.

Cooked foods must be stored in such a way that new microbes will not contaminate it, and that those that were not killed do not have the chance to grow further. The South African regulation R962 of 2012 require hot foods to be held at 65°C or higher temperatures. If a cooked food is to be chilled, it must be cooled to 70°C, but not below 65°C, before storing in a holding fridge.

When kitchens and factories apply cleaning, segregation and temperature control appropriately, it will substantially reduce the risk of microbial problems in the final product.

Article by: Gillian de Villiers