Kombucha es un producto que se puede producir de manera segura tanto en casa como de manera comercial. Al ser un alimento tradicional fermentado, sus componentes microbianos y los ácidos orgánicos que produce aseguran que se mantenga bien preservada, incluso sin refrigeración. El papel de los alimentos fermentados precede otros tipos de tecnologías de preservación tales como refrigeración, pasteurización o conservantes químicos.

Colombia tiene una larga historia de utilizar alimentos fermentados para proveer alimentos altos en nutrientes a su población nativa. La cassava, el cacao y el maíz han sido fermentados por medio de procesos tradicionales para crear almidón agrio, chicha, champús, masa agria, guarapo, y muchas cosas más .

La kombucha es originaria de Asia y ha viajado por el mundo muchas veces donde ha disfrutado de popularidad como una bebida casera en China, Japón, Corea, Rusia, Alemania, Italia y Estados Unidos. Fue en los Estados Unidos donde la bebida salió a la venta por primera vez en 1995.

KBI responde a cada una de las preocupaciones del gobierno colombiano para demostrar que la industria comercial de kombucha tiene políticas responsables y proactivas establecidas para asegurar la seguridad de nuestros productos para todos. Sabemos que esta vibrante industria puede ofrecer una alternativa saludable tanto a los refrescos y jugos como a las bebidas energéticas llenas de químicos. Empoderar y educar a los productores de kombucha crea un ambiente donde los consumidores tienen más opciones, ofrece oportunidades económicas para más personas y genera una población más saludable, lo cual la responsabilidad del gobierno.


Kombucha Brewers International Response to INVIMA of Colombia

Kombucha is an incredibly safe product to brew at home as well as commercially. As a traditional fermented food, it’s microbial makeup and the organic acids it produces ensures that it is well preserved even without refrigeration. The role of fermented foods far precedes other types of preservation technology such as refrigeration, pasteurization or chemical preservatives.

Colombia has a long history of using fermented foods to provide nutrient dense foods for their native population. Cassava, cacao and maize have all been fermented through traditional processes to create almidón agrio, chicha, champús, masa agria, guarapo and many more. Kombucha originates in Asia and has traveled the world many times over where it has enjoyed popularity primarily as a home brewed beverage from China, Japan and Korea to Russia, Germany, Italy and the United States. It is in the US where the beverage first became available for purchase in 1995.

KBI addresses each of the concerns laid out by the Colombian government to demonstrate that the commercial kombucha industry has responsible and proactive policies in place to ensure the safety of our products for all people. We know that this vibrant industry can provide a healthier alternative to sugary sodas and juices as well as chemical laden energy drinks. Empowering and educating kombucha producers creates an environment where consumers have more choice, provides economic opportunities to more people and generates a healthier populace which reduces the burden on governments.

 

¿Cómo garantizar el contenido microbiológico para garantizar la ausencia de patógenos?

Con respecto a la seguridad de producción y el consumo humano, sus miles de años de historia son un testamento, ya que los humanos no consumirían recursos, tiempo o energía produciendo un alimento que los dañara. Varios estudios han demostrado que el nivel de pH y el perfil de ácido orgánico de la kombucha previene la contaminación a manos de patógenos comunes, incluyendo E. coli, salmonela, listeria, entre otros.

Los invitamos a leer nuestra hoja informativa de la industria para encontrar información adicional.

How does one ensure microbiological content to guarantee the non-presence of pathogens?

Regarding safety for production and human consumption, its thousands-year-old history is a testament, as humans would not spend resources, time or energy on producing a food that could harm them. Many research papers have demonstrated that kombucha’s unique pH level and organic acid profile prevents contamination by a host of common pathogens including E. coli, Salmonella, Listeria and many others.

We invite you to read our industry fact sheet for additional information.

 

¿Cuáles son las mejores prácticas, procesos y regulaciones que la industria utiliza para garantizar la cualidad del SCOBY?

Pueden leer las Mejores Prácticas de KBI aquí → https://kombuchabrewers.org/wp-content/uploads/2019/06/Best-Practices-Espa%C3%B1ol.pdf

KBI ha trabajado con muchos gobiernos para garantizar que prácticas seguras sean utilizadas y ayudó de manera directa a los productores brasileños para establecer su Estándar de Identidad, el cual menciona algunas de las especificaciones técnicas fundamentales para la kombucha. KBI hará público su Código de Prácticas y programa de privacidad en verano del 2020.

What are the best Practices, process and controls that the industry uses to guarantee the SCOBY quality?

You may read the KBI Best Practices in Spanish here →

https://kombuchabrewers.org/wp-content/uploads/2019/06/Best-Practices-Espa%C3%B1ol.pdf

KBI has worked with many governments to ensure safe practices are utilized and directly assisted our Brazilian producers to establish their Standard of Identity, which lists some of the critical technical specifications for kombucha. KBI will be releasing our Code of Practice and seal program in the summer of 2020.

 

¿Qué características físicas o químicas son analizadas para aprobar la calidad del SCOBY?

Los miembros de KBI reciben entrenamiento para desarrollar planes HACCP para garantizar la seguridad de las prácticas de producción y demostrar un amplio conocimiento de sus procesos. Nuestros puntos críticos de control consisten en niveles de pH controlados en todo momento junto con inspecciones visuales para eliminar los cultivos que presenten moho. Al ser un organismo abundante, cualquier manifestación es visible para el ojo de inmediato ya que el moho que se produce en la kombucha es el mismo que se produce en cualquier otro alimento.

What physical or chemical characteristics are analyzed to approve the quality of the SCOBY?

KBI members receive training in how to develop HACCP plans to ensure safe brewing practices and to demonstrate full knowledge of their processes. Our critical control points consist of proper pH levels maintained at all times along with visual inspections to eliminate cultures that exhibit mold. As a hearty organism, any infestation is immediately apparent to the naked eye, as the mold that occurs on kombucha is the same as mold on any other food product.

 

Si el SCOBY se echa a perder, ¿qué se puede hacer para reestablecer su calidad?

Los SCOBY normalmente son organismos resistentes, y mientras tengan los nutrientes y los controles ambientales apropiados, son fáciles de cuidar. Los cultivos de moho y todo el líquido deben desecharse de inmediato. Los SCOBY pueden conseguirse por medio de proveedores comerciales o pueden crearse nuevos cultivos al trabajar con los saludables que ya se tienen.

If the SCOBY goes bad, what can be done to reestablish  SCOBY quality?

SCOBYs are generally hardy organisms, and as long as they have proper nutrients and environmental controls, they are easy to care for. Moldy cultures, along with all of the liquid, are to be disposed of immediately. SCOBYs are available for purchase from commercial suppliers, or new cultures may be cultivated by working with existing cultures that are healthy.

 

¿Hay documentos con las prácticas principales de la industria para detener la fermentación del alcohol?

Como se menciona en Mejores Prácticas, la kombucha cruda almacenada a la temperatura apropiada mantiene el control de calidad por más tiempo. La kombucha tradicional es fermentada, baja en alcohol sin efectos embriagantes que normalmente se consume cruda, es decir no pasteurizada, para proteger los probióticos y los nutrientes vivos y evitar que se dañen.

Que no esté pasteurizada significa que no ha sido tratada con calor ni químicos. Al seguir siendo un producto en crudo, puede experimentar leves cambios en etanol mientras el proceso de fermentación continúa dentro de la botella.

Para detener el proceso, la kombucha cruda debe mantenerse fría en todo momento para mantener la integridad del producto y prevenir la fermentación dentro de la botella.

La temperatura del almacenamiento debe mantenerse a una temperatura de 34-40º F /1.1-4.4ºC para alentar la fermentación de la kombucha a lo largo de la cadena de suministro.

La vida útil de la kombucha se define por la cantidad de tiempo que puede permanecer almacenada en frío antes de que los niveles de etanol sobrepasen el límite legal (que varía dependiendo de la ubicación).

Los productos que dicen ser crudos y poder almacenarse no se reconocen como estables sin evidencia complementaria empírica por parte de un laboratorio de pruebas de terceros para verificar que el nivel de etanol se mantenga dentro del límite legal de su ubicación. Productos de este tipo no existen en el mercado estadounidense ya que la kombucha cruda está sujeta a su refrigeración.

Are there documents with the industry leading practices to stop the alcoholic fermentation.

As outlined in the Best Practices, raw kombucha stored at the appropriate temperatures maintains quality control for extended periods of time. Kombucha is a traditionally fermented, low alcohol, non-intoxicating beverage that is most commonly consumed raw, meaning unpasteurized, to protect the probiotics and nutrients in a living form from being damaged.

Unpasteurized means not subject to pasteurization via heat or chemical means. As a result of remaining a raw product, it can experience slight shifts in ethanol as the fermentation process continues in the bottle.

To arrest that process, raw Kombucha must be kept cold at all times to maintain the integrity of the product and to prevent over fermentation in the bottle.

Cold storage ought to be maintained at 34-40º F /1.1-4.4ºC to slow the fermentation of the Kombucha throughout the supply chain.

Shelf life of Kombucha is determined by how long the product can remain in cold storage before the ethanol level goes above the prescribed legal limit (will vary based on location).

Products that claim to be both shelf-stable and raw are not currently recognized as stable without further evidence vis-a-vis shelf life testing by a third party lab to verify that the ethanol level remains within the legal limit for that location. No such products currently exist in the US marketplace as all raw Kombucha is subject to refrigeration.

 

¿Hay documentos donde podemos probar que la FDA ha confirmado que la kombucha es legal; que está catalogada como una comida y es segura para consumo humano?

Todos los miembros de KBI en Estados Unidos deben matricular sus instalaciones de acuerdo con la Ley contra el Bioterrorismo del 2002. Hay más de 750 marcas comerciales de kombucha en Estados Unidos nada más. Así que aunque la FDA no tiene una postura oficial en cuanto a la kombucha, claramente está enterada de la industria y lo considera un producto seguro.

Is there documentation to prove the FDA has stated that Kombucha is legal; that is catalogued as a food and save to consume by humans?

All KBI members based in the U.S. are required to enroll their facility in accordance with the Bioterrorism Act of 2002. There are more than 750 commercial kombucha brands in the United States alone. So while the FDA doesn’t have an official stance on kombucha, it is clearly aware of the industry and considers our products safe.

 

¿Tienen algún documento que pueda ayudarnos en nuestra misión de hacer legal la kombucha en Colombia?

Múltiples estudios discuten los beneficios para los humanos. Aquí hay una reseña de varios estudios sobre este tema:

https://www.researchgate.net/profile/Joselina_Huerta/publication/323136183_A_review_on_health_benefits_of_kombucha_nutritional_compounds_and_metabolites/links/5cf99170299bf13a384327a5/A-review-on-health-benefits-of-kombucha-nutritional-compounds-and-metabolites.pdf


Are there any toxicological studies that proves that kombucha is safe for human consumption?

Numerous studies discuss its benefits for humans. Here is a review of several studies on this subject:

https://www.researchgate.net/profile/Joselina_Huerta/publication/323136183_A_review_on_health_benefits_of_kombucha_nutritional_compounds_and_metabolites/links/5cf99170299bf13a384327a5/A-review-on-health-benefits-of-kombucha-nutritional-compounds-and-metabolites.pdf

 

¿Hay estudios que prueben que mantener el nivel de pH de la kombucha debajo de 3.5 es un método aprovado para evitar los patógenos en la kombucha?

Un conocimiento básico de química puede probar que esto es verdad. Aquí hay algunos estudios adicionales que se pueden revisar:

https://research.kombuchabrewers.org/?query=antibacterial

Are there any studies that proves that maintaining the kombucha ph below 3.5 is an approved method to keep pathogens out of the kombucha?

Simple knowledge of chemistry will prove that to be true. Here are some additional studies for review:

https://research.kombuchabrewers.org/?query=antibacterial

 

¿Hay documentos que prueben que la kombucha no genera metanol durante el proceso de fermentación?

Ninguno de los estudios sobre la kombucha han mostrado la presencia de metanol. La producción de metanol se relaciona con la cantidad de pectinas en la hierba. El té y el azúcar no contienen pectinas y, por lo tanto, no pueden producir metanol.

Any documents that proves that kombucha does not generate methanol in the fermentation process?

None of the studies on kombucha have shown the presence of methanol. Methanol production is linked to pectin content in the wort. Tea and sugar do not contain pectin and therefore cannot produce methanol.

 

¿Tienen algún documento que pueda ayudarnos en nuestra misión de hacer legal la kombucha en Colombia?
Any other document that you have that can help us in our quest to make legal kombucha in Colombia?

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-110300-registration-food-facilities-under-public-health-security-and-bioterrorism

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5028366/

Entra a la base de datos de investigaciones sobre kombucha → https://research.kombuchabrewers.org/

Access the Kombucha Research Database here to find numerous studies → https://research.kombuchabrewers.org/

 

ALERTA SANITARIA Dirección de Alimentos y Bebidas Alerta No. 024-2020

Alimentos que se comercializan con la expresión “Kombucha”

Nombre del producto: Alimentos que se comercializan con la expresión “Kombucha”

Registro sanitario: RSAV15I10313/RSA-004946-2017 / RSA-006687-2018 /RSA-005012-2017 / RSA-0007265-2018 / NSA-005392-2018

Fuente de la alerta: Denuncias y acciones de inspección, vigilancia y control (IVC) No. Identificación interno: AA200101

Descripción del caso El Instituto Nacional de Vigilancia de Medicamentos y Alimentos (Invima) informa a la comunidad, que conforme a las competencias de inspección, vigilancia y control se han detectado irregularidades en relación con la siguiente declaración en alimentos: Kombucha es una bebida elaborada a partir de té endulzado y fermentado utilizando un cultivo simbiótico de bacterias y levaduras (SCOBY). En el mercado se han encontrado algunas bebidas que utilizan como ingrediente el “SCOBY”. Al cual se le atribuyen diferentes propiedades en salud, según referencias bibliográficas . Cabe anotar que el “SCOBY” es un ingrediente que no ha sido autorizado por el Invima para su uso en alimentos y bebidas. Bogotá, 19 Febrero 2020 Marcas “o.k. kombucha”, “Alino”, “HAPPY”, “La fantástica”, “Kogui kombucha”, “Coordenada 0” y “Yogi”

Por lo anterior el Invima se permite informar a la población en general que los alimentos que se comercializan en Colombia y que contienen la expresión kombucha, presentan la siguiente situación sanitaria:

1. En relación con la autorización para comercializar alimentos a los cuales el Invima les otorgó Registro Sanitario o Notificación Sanitaria, y que están utilizando dentro de su composición el ingrediente “SCOBY” o están haciendo uso de la expresión “Kombucha”, el Invima hace claridad de lo siguiente:

a) Para el Registro Sanitario RSAV15I10313 correspondiente al alimento “bebida con té diferentes variedades”, que incluye las marcas “o.k. kombucha”, “alino”, en presentación comercial caja por 6, 12 y 24 unidades de 250, 330, 500 y 1000 mililitros, y cuyo fabricante es Cohen Leiderman Flora propietaria del establecimiento de comercio o.k. kombucha, mediante acciones de Inspección, Vigilancia y Control se evidenció que el fabricante utiliza “cultivo probiótico de Kombucha”, el cual no está aprobado en el Registro Sanitario, así como el incumplimiento del rotulado y publicidad de la bebida con té variedades, marca kombucha.

b) Para el Registro Sanitario RSA-004946-2017 correspondiente al alimento “bebida con té diferentes variedades”, que incluye la marca “HAPPY” en presentación comercial botellas (PET o vidrio) de 120, 180, 200, 250, 320, 350, 500, 750, 1000 y 3780 mililitros, y cuyo fabricante es Drink With Purpose S.A.S, se evidenció que en el proceso de fabricación del alimento se estaba llevando a cabo fermentación alcohólica obtenida mediante la adición del “SCOBY” como ingrediente y, adicionalmente, el rotulado del alimento hace alusión a la expresión “kombucha”.

c) Para el Registro Sanitario RSA-006687-2018 correspondiente al alimento “bebida con té”, que incluye la marca “La fantástica” en presentación comercial botellas de 200, 400, 600, 800 y 1000 mililitros, y cuyo fabricante es ST Agnes Brewing Company té vivo la fantástica, se evidenció que la actual dirección del fabricante no corresponde con la suministrada ante el Invima al momento de solicitar el Registro Sanitario.

d) Para el Registro Sanitario RSA-005012-2017 correspondiente al alimento “Bebida con té verde y negro diferentes variedades”, que incluye la marca “Kogui kombucha” en presentación comercial de 250 a 1000 mililitros, y cuyo fabricante es el establecimiento de comercio Koghi Products, se evidenció que en el proceso de fabricación del alimento se estaba llevando a cabo fermentación alcohólica, no autorizada.

e) El Registro Sanitario RSA-0007265-2018 correspondiente al alimento “bebida a base de agua y té”, que incluye la marca “Coordenada 0” en presentación comercial de frasco de vidrio de 10 hasta 10000 mililitros, y cuyo fabricante es Coordenada 0 SAS, se encuentra suspendido.

f) Para la Notificación Sanitaria NSA-005392-2018 correspondiente al alimento “Infusiones de té diferentes variedades”, que incluye la marca “Yogi” en presentación comercial bolsas de té y cuyo fabricante es “East West Tea Company” (Estados Unidos) e importado a Colombia por Green Tradings S.A.S., se evidenció que la dirección suministrada ante el Invima por el importador corresponde a un domicilio del cual se desconoce el tipo de actividad comercial allí realizada.

2. Respecto a la vigilancia de la publicidad en diferentes medios, el Invima identificó que en algunas páginas de internet se promocionan alimentos que utilizan la expresión Kombucha, declarando propiedades en salud; preventivas, curativas y/o terapéuticas, lo que conlleva al incumplimiento de la legislación sanitaria vigente (artículos 272 y 274 de la ley 9 de 1979 y la resolución 5109 de 2005 – artículos 4 y 5). Se enlistan algunas de las páginas de internet en donde se ha identificado este tipo de publicidad:

a. https://fitfoodmarket.co/tienda/bebidas-y-tes/happy-kombucha/

b. https://moncielvidasana.com/kombucha-kefir-y-fermentos/132-104-kombucha-la-fantastica210mL.htmL

c. https://articulo.mercadolibre.com.co/MCO-483957130-yogi-tea-kombucha-te-verde-16-ea- _JM?quantity=1#position=10&type=item&tracking_id=fd88e642-a51c-463d-bc5e-dad3c8e721dc

d. https://www.instagram.com/kombuchalafantastica/?hl=es-la

e. https://www.instagram.com/koguikombucha/?hl=es-la

f. https://happykombuchalab.com/

g. https://www.instagram.com/ok_kombucha/

h. https://www.facebook.com/OKKombucha.ca/

i. https://kombuchalafantastica.com/

j. https://www.alivekombucha.co/

k. https://www.instagram.com/bvida.kombucha/?hl=es-la

l. https://www.instagram.com/tevivokombucha/?hl=es-la

m. https://www.instagram.com/guarapakombucha/?hl=es-la

n. https://www.instagram.com/aborigenkombucha/?hl=es-la

o. https://es-la.facebook.com/kombucha0/

De acuerdo con lo descrito anteriormente, el Invima advierte que los productos relacionados no cumplen con la normatividad sanitaria y por lo tanto no están autorizados para su comercialización, razón por la cual, se están adelantando las actuaciones administrativas para verificar las condiciones de los registros sanitarios y las declaraciones de los ingredientes de cada uno de los productos. Medidas para la comunidad en general Considerando lo anterior, tenga en cuenta los siguientes aspectos: 1. Absténgase de adquirir y consumir los alimentos que listen o hagan alusión a las expresiones “Kombucha” o “SCOBY”, u otros que existan en el mercado, tengan o no Registro Sanitario, y que utilicen en su rótulo palabras asociadas a las expresiones anteriormente descritas. 2. Informe de manera inmediata al Invima, o a las Entidades Territoriales de Salud, si tiene conocimiento de lugares donde se elaboren, distribuyan o comercialicen alimentos que listen dentro de sus ingredientes “SCOBY” o que declaren en su denominación la expresión “Kombucha”.

Medidas para secretarías de salud departamentales, distritales y municipales Categoría Especial, I, II y III:

1. Realizar las actividades de inspección, vigilancia y control (IVC) en los establecimientos donde potencialmente puedan comercializarse los alimentos citados, verificando la existencia de productos que declaren las expresiones “SCOBY” y/o “Kombucha” en su rotulado o etiquetado.

2. Durante las actividades de Inspección, Vigilancia y Control (IVC) verificar si existe publicidad de alimentos que incluyan las expresiones “SCOBY” y/o “Kombucha” y su relación con propiedades en salud; preventivas, curativas y/o terapéuticas.

3. Comunicar al Invima los resultados de las acciones de Inspección, Vigilancia y Control (IVC) a los correos alertasalimentos@invima.gov.co y contactoets@invima.gov.co, en caso de evidenciar uno o más de los incumplimientos referidos. Si desea obtener mayor información comuníquese con el Invima a: alertasalimentos@invima.gov.co o al teléfono 294 8700, extensiones 3844 y 3846 – Dirección de Alimentos y Bebidas. Igualmente se podrán realizar peticiones, quejas, reclamos, denuncias o sugerencias: https://www.invima.gov.co/peticiones-quejas-reclamos-y-sugerencias Consultar registros sanitarios: http://consultaregistro.invima.gov.co:8082/Consultas/consultas/consreg_encabcum.jsp En los siguientes enlaces podrá acceder directamente a la información de su interés en la página web del Invima. Realizar peticiones, quejas, reclamos, denuncias o sugerencias Consultar registros sanitarios Realizar reportes en línea de eventos adversos  Farmacovigilancia Reactivovigilancia Tecnovigilancia

 

HEALTH ALERT Food and Beverage Department Alert No. 024-2020

Foods that are marketed  with the expression “Kombucha”

Product name: Foods that are marketed with the expression “Kombucha”

Sanitary record: RSAV15I10313 / RSA-004946-2017 / RSA- 006687-2018 / RSA-005012-2017 / RSA-0007265-2018 / NSA-005392-2018

Source of alert: Complaints and actions of inspection, surveillance and control (IVC) No. Internal identification: AA200101

Description of the case The National Institute of Food and Drug Surveillance (Invima) informs the community that, according to the inspection, surveillance and control powers, irregularities have been detected in relation to the following food declaration: Kombucha is a beverage made from sweetened and fermented tea using a symbiotic culture of bacteria and yeasts (SCOBY). In the market some drinks have been found that use the “SCOBY” as an ingredient. To which different health properties are attributed, according to bibliographic references. It should be noted that the “SCOBY” is an ingredient that has not been authorized by the Invima for use in food and beverages. Bogotá, February 19, 2020 Marks “ok kombucha”, “Alino”, “HAPPY”, “La fantastic”, “Kogui kombucha”, “Coordinate 0” and “Yogi”

By the above the Invima is allowed to inform the general population that the foods that are sold in Colombia and that contain the expression kombucha, present the following sanitary situation:

1. In relation to the authorization to commercialize foods to which the Invima granted them Sanitary Registry or Sanitary Notification, and that they are using the ingredient “SCOBY” within their composition or are making use of the expression “Kombucha”, the Invima makes clear of the following:

a) For the Sanitary Registry RSAV15I10313 corresponding to the food “drink with different varieties of tea ”, which includes the brands“ ok kombucha ”,“ alino ”, in commercial presentation box for 6, 12 and 24 units of 250, 330, 500 and 1000 milliliters, and whose factory before Cohen Leiderman Flora owns the ok kombucha trade establishment, through Inspection, Surveillance and Control actions it was evidenced that the manufacturer uses “Kombucha probiotic culture”, which is not approved in the Sanitary Registry, as well as the breach of the labeling and advertising of the beverage with tea varieties, Kombucha brand.

b) For the Sanitary Registry RSA-004946-2017 corresponding to the food “drink with tea different varieties”, which includes the brand “HAPPY” in commercial presentation bottles (PET or glass) of 120, 180, 200, 250, 320, 350 , 500, 750, 1000 and 3780 milliliters, and whose manufacturer is Drink With Purpose SAS, it was evidenced that alcoholic fermentation was obtained in the food manufacturing process obtained by adding “SCOBY” as an ingredient and, additionally, the labeling of the food refers to the expression “kombucha”.

c) For the Sanitary Registry RSA-006687-2018 corresponding to the food “drink with tea”, which includes the brand “The fantastic” in commercial presentation bottles of 200, 400, 600, 800 and 1000 milliliters, and whose manufacturer is ST Agnes Brewing Company live the fantastic, it was evident that the current address of the manufacturer does not correspond to that supplied before the Invima at the time of requesting the Sanitary Registry.

d) For the Sanitary Registry RSA-005012-2017 corresponding to the food “Drink with green and black tea different varieties”, which includes the brand “Kogui kombucha” in commercial presentation of 250 to 1000 milliliters, and whose manufacturer is the establishment of commerce Koghi Products, it was evidenced that in the process of manufacturing the food alcoholic fermentation was taking place, not authorized.

e) The Sanitary Registry RSA-0007265-2018 corresponding to the food “drink based on water and tea”, which includes the brand “Coordinate 0” in commercial presentation of glass jar of 10 up to 10,000 milliliters, and whose manufacturer is Coordinate 0 SAS, is suspended.

f) For the Sanitary Notification NSA-005392-2018 corresponding to the food “Tea infusions different varieties”, which includes the brand “Yogi” in commercial presentation of tea bags and whose manufacturer is “East West Tea Company” (United States) and Imported to Colombia by Green Tradings SAS, it was evidenced that the address supplied to the Invima by the importer corresponds to a domicile whose type of commercial activity is unknown.

2. Regarding the surveillance of advertising in different media, Invima identified that in some websites, foods that use the expression Kombucha are promoted, declaring health properties; preventive, curative and / or therapeutic, which leads to non-compliance with current health legislation (articles 272 and 274 of law 9 of 1979 and resolution 5109 of 2005 – articles 4 and 5). Some of the websites where this type of advertising has been identified are listed:

a. https://fitfoodmarket.co/tienda/bebidas-y-tes/happy-kombucha/

b. https://moncielvidasana.com/kombucha-kefir-y-fermentos/132-104-kombucha-la-fantastica210mL.htmL

c. https://articulo.mercadolibre.com.co/MCO-483957130-yogi-tea-kombucha-te-verde-16-ea- _JM? quantity = 1 # position = 10 & type = item & tracking_id = fd88e642-a51c-463d-bc5e- dad3c8e721dc

d. https://www.instagram.com/kombuchalafantastica/?hl=en-la

e. https://www.instagram.com/koguikombucha/?hl=en-la

f. https://happykombuchalab.com/

g. https://www.instagram.com/ok_kombucha/

h. https://www.facebook.com/OKKombucha.ca/

i. https://kombuchalafantastica.com/

j. https://www.alivekombucha.co/

k. https://www.instagram.com/bvida.kombucha/?hl=en-la

l. https://www.instagram.com/tevivokombucha/?hl=en-la

m. https://www.instagram.com/guarapakombucha/?hl=en-la

n. https://www.instagram.com/aborigenkombucha/?hl=en-la

or. https://es-la.facebook.com/kombucha0/

As described above, Invima warns that the related products do not comply with sanitary regulations and therefore are not authorized for marketing, which is why, administrative actions are being carried out to verify the conditions of the sanitary records and the declarations of the ingredients of each of the products.

Measures for the community in general considering the above, consider the following aspects:

1. Refrain from acquiring and consuming the foods you listen to or make reference to the expressions “Kombucha” or “SCOBY”, or others that exist in the market, whether or not they have a Sanitary Registry, and that use words associated with the expressions described above on their label.

2. Immediately inform Invima, or the Territorial Health Entities, if you are aware of places where food is prepared, distributed or marketed within the “SCOBY” ingredients or that declares the expression “Kombucha” in its name.

Measures for departmental, district and municipal health secretariats Special Category, I, II and III:

1. Carry out inspection, surveillance and control (IVC) activities in establishments where the aforementioned foods can potentially be marketed, verifying the existence of products that declare the expressions “SCOBY” and / or “Kombucha” in their labeling or labeling.

2. During the Inspection, Surveillance and Control (IVC) activities, verify whether there is food advertising that includes the expressions “SCOBY” and / or “Kombucha” and its relation to health properties; preventive, curative and / or therapeutic.

3. Communicate to Invima the results of the Inspection, Surveillance and Control (IVC) actions to the emails alertsalimentos@invima.gov.co and contactoets@invima.gov.co, in case of evidencing one or more of the aforementioned breaches. If you would like more information, please contact the Invima at: alertsalimentos@invima.gov.co or by phone 294 8700, extensions 3844 and 3846 – Food and Beverage Department. Likewise, requests, complaints, claims, complaints or suggestions may be made: https://www.invima.gov.co/pecionales-quejas-reclamos-y-sugerencia Consult health records: http://consultaregistro.invima.gov.co : 8082 / Queries / consultations / consreg_encabcum.jsp In the following links you can directly access the information of your interest on the Invima website. Make requests, complaints, claims, complaints or suggestions Consult health records Make online reports of adverse events  Pharmacovigilance Reagent Surveillance Tecnovigilancia

 

Here are some additional resources and websites to monitor for safety tips and updates. Stay safe & healthy!

Coronavirus: Tips for Self-Protection. Be cautious, but don't panic! Prevention is similar to avoiding other illnesses.

Please sign up here to stay in the loop for KKON and all Kombucha industry-related news.

General Information

Draft Kombucha and Taproom Information

Kombucha Brewery Facility Information

  • Center for Disease Control and Prevention: Interim Guidance for Businesses and Employers
  • Occupational Safety and Health Administration: COVID-19 Control and Prevention
  • FDA briefing to food stakeholders:
    • There has been NO evidence of the transmission of the Coronavirus from food or food packaging.
    • Food products do not have to be placed on-hold or recalled if an employee at a food facility is diagnosed with COVID-19.
    • Personal hygiene, as well as facility, equipment, and utensil cleaning and sanitization procedures that are required in GMPs, are expected to still be appropriate amid this crisis.
    • Now routine domestic inspections will also be postponed and only “mission-critical” inspections will be conducted as necessary in cases where there is Class I Recall, a foodborne outbreak, or COVID-19 related situation.
    • Ensuring a continuous supply of safe food is a critical factor for the US and the FDA and Department of Homeland Security are working together to ensure that is the case. Food facilities involved in this supply, are therefore not subject to the quarantine and shelter in place orders and any issues with this should be addressed to the latter and FEMA.

Small Business Assistance 

Essential Businesses
The definition may vary according to your local ordinance. These businesses may carry your products and/or your facility may be able to offer to pick up or delivery. 

  • Grocery stores, certified farmers’ markets,  farm and produce stands, supermarkets, food banks,  convenience stores,  and other establishments engaged in the retail sale of canned food, dry goods, fresh fruits and vegetables, pet supply, fresh meats, fish, and poultry, and any other household consumer products (such as cleaning and personal care products).  This  includes  stores that sell groceries and also sell other non-grocery products, and  products necessary to maintain the safety, sanitation, and essential operation of residences”
  • Restaurants and other facilities that prepare and serve food, but only for delivery or carry out – social distancing measures must be practiced
  • Businesses that ship or deliver groceries, food, goods or services directly to residences

International Information

Join the conversation in the KBI Members Forum

Guidance for Travelers

“Essential Travel” includes travel for any of the following purposes. Individuals engaged in any Essential Travel must comply with all Social Distancing Requirements
Any travel related to the provision of or access to Essential Activities, Essential Governmental Functions, Essential Businesses, or Minimum Basic Operations

Travelers are encouraged to always exercise healthy travel habits when traveling and to follow guidance issued by official sources of public health information.

Are we missing a vital resource? Please send your link to admin@kombuchabrewers.org so we can share them here.

What is Proposition 65?

The Safe Drinking Water and Toxic Enforcement Act was approved by California voters in 1986 and is known today as Proposition 65 and requires the State of California to publish a list of chemicals and substances known to cause cancer or birth defects or other reproductive harm. Proposition 65 is administered by the Office of Environmental Health Hazard Assessment (OEHHA). OEHHA has listed over 900 chemicals, including naturally occurring and synthetic chemicals present in foods, beverages, pesticides, commonly used household products and personal care products, and more. Proposition 65 is a right-to-know statute; it does not prohibit businesses from selling anything in California. Rather, it requires businesses to provide a “clear and reasonable” warning to Californians before knowingly and intentionally exposing them to a listed chemical or substance. A warning must be given for listed chemicals and substances unless exposure is low enough to pose no significant risk of cancer, or is significantly below levels observed to cause birth defects or other reproductive harm.

Proposition 65 And Alcoholic Beverages

OEHHA listed alcohol under Proposition 65 over two decades ago, first listing “ethyl alcohol in alcoholic beverages” as a reproductive toxicant in 1987, then “alcoholic beverages when associated with alcohol abuse” as a carcinogen in 1988, and most recently, “alcoholic beverages” as a carcinogen in 2011.

Safe Harbor Levels

For chemicals listed as carcinogens, the “no significant risk level” (NSRL) is defined as the level of exposure that would result in not more than one excess case of cancer in 100,000 people exposed to the chemical over a 70-year lifetime. For chemicals listed as reproductive toxicants, the “no observable effect level” is determined by identifying the level of exposure that has been shown to not pose any harm to humans or laboratory animals. This number is then divided by 1,000 to establish the “maximum allowable dose level” (MADL). OEHHA has established NSRLs and MADLs known as “safe harbors” for some, but not all, of the listed chemicals. If your product contains a Proposition 65 listed chemical at levels below the established safe harbors, you do not need to provide a warning.

No Safe Harbor Guidance For Alchohol

OEHHA has not established safe harbors for any of the Proposition 65 alcohol listings. Businesses that expose individuals to a Proposition 65 listed chemical that does not have an established safe harbor must either provide a Proposition 65 warning or must show that the exposure level will not pose a significant risk of cancer or reproductive harm. Determining the anticipated exposure level is not a simple endeavor and often requires an expensive scientific exposure assessment.

How to Warn

Although most manufacturers may apply Proposition 65 warnings directly to product labels, this is not the case for alcoholic beverages. Why? All alcoholic beverage labels must be approved by the Federal Alcohol & Tobacco Tax and Trade Bureau (TTB) and contain the federal warning on the products. The federal warning is not the same as—and is not compliant with—the Proposition 65 warning requirements and thus does not provide a safe harbor under California law. The above warning does not apply to non-alcoholic beverages. For retail sales of alcoholic beverages in stores, businesses may warn by (1) posting the above warning on an 8 ½ x 11-inch sign in at least 22-point font, placed at eye level so it is conspicuous to customers upon entering the area where alcoholic beverages are sold, or by (2) posting the above warning on a 5 x 5-inch sign in at least 20-point font, placed at each retail point of sale or display so it is conspicuous to customers. For alcohol provided for consumption on-premises, or sold over-the-counter, the above warning language must be provided on the drink menu. For alcohol sold or distributed within California through delivery services, a warning must be placed on or in the shipping container/delivery package, in a font at least as big as the rest of the text on the package

Proposition 65 and Non-Alcoholic Beverages

While Proposition 65 is nothing new for the alcoholic beverage industry, Proposition 65 private enforcers have recently targeted traditionally non-alcoholic products based on the alcohol-related Proposition 65 chemicals. Several kombucha retailers and manufacturers have recently been served with notices of violation based on alleged exposure to “ethyl alcohol in alcoholic beverages” and “alcoholic beverages.” In many cases, kombucha is not produced or marketed as an alcoholic beverage, but trace amounts of alcohol may result from the fermentation process, none of which are knowingly or intentionally added to the product before sale. Proposition 65 does not define an alcoholic beverage. Rather, it is defined in the Alcoholic Beverage Control Act as containing 0.5% alcohol by volume or more. See CA Bus. & Prof. Code § 23004. It is yet to be seen how the plaintiffs’ bar will attempt to tie the 0.5% ABV definition to Proposition 65, a potential safe harbor level, or the risk of cancer or reproductive toxicity. In the meantime, it is important to have a comprehensive compliance program in place with regular product testing.

Have you received a Prop 65 Notice? Email info@kombuchabrewers.org for guidance & support (membership not required)

References

https://www.p65warnings.ca.gov/products/alcoholic-beverages

Proposition 65 and Alcohol

HARPC is the evolution of HACCP. This article outlines the steps needed to comply with new regulations from the FDA for United States-based producers. Other countries may require similar documentation and we recommend all Kombucha brewers have some form of plan in place to control for any potential hazards or risks.

1. Conduct Hazard Analysis

The “HA” in HARPC stands for “Hazard Analysis” and addresses the core intent of the law: to identify hazards due to the specific foods or food ingredients in the food or due to the various processing, manufacturing, packing, and holding steps applied to the foods. Once identified, the company must evaluate each hazard to assess its probability of occurring and severity of the injury it would bring. This step is designed to prepare the firm for identifying the steps necessary to minimize or prevent the hazards from arising.

To identify the hazards, the company must consider following:

  • Known or reasonably foreseeable hazards:
  • biological hazards (pathogenic bacteria, viruses, mold or parasites)
  • chemical hazards (cleaning agents, pest control substances)
  • physical hazards (extraneous or foreign matter such as glass)
  • Natural toxins, pesticides, drug residues, decomposition, parasites, allergens, and unapproved food and color additives
  • Naturally occurring hazards or unintentionally introduced hazards
  • Intentionally introduced hazards for economic gain

After identifying the hazards, the Company must evaluate each by considering formulation, ingredients, facilities, equipment, production flow, storage, and transportation. The Company must also look into relevant factors that could contribute to each hazard throughout the food facility, its operations and personnel, including personnel screening and controls, the entire supply chain of a facility’s food ingredients (raw materials, packaging, dyes, labels, etc.), and the finished foods received, delivered and shipped.

Companies must create a written analysis of the above hazards, in English, so that FDA can review it during inspection or upon request.

2. Risk-based Preventive Controls

The “RPC” in HARPC stands for “Risk-based Preventive Controls.”  This portion of HARPC requires companies, whether foreign or domestic, to develop and implement a series of risk-based controls to significantly minimize or prevent the identified hazards to ensure the safety of the food it manufactures, processes, holds and distributes. The Company must designate controls at food processing steps that are appropriate for ensuring the safety of the food, especially, the critical control point (CCP). CCPs are critical manufacturing points, where the Company can apply controls to minimize or eliminate the hazard or reduce the hazard to an acceptable level under normal manufacturing operations.

Examples of types of preventive controls include:

  • Sanitation procedures at food surface contact points
  • Sanitation of utensils and equipment
  • Staff hygiene training
  • Food allergen control program
  • Recall plan
  • Current Good Manufacturing Practices (cGMPs)
  • Supply-chain controls

The Company must have written preventive controls.
For each hazard that requires a preventive control, the Company must establish a written recall plan.

If a particular hazard will be controlled by another facility in the supply-chain (whether a supplier or later distributor/processor), the Company is not required to implement a preventive control as long as the Company records and obtains written assurance from the other facility that the hazard is being controlled.

3.  Monitoring of Effectiveness

HARPC requires the food facility to establish and implement a written monitoring program, which ensures the firm is conducting regular evaluations of the facility’s control measures to determine that the preventive controls are working.   FDA will evaluate the firm’s monitoring system to identify inadequacies in either the methods of monitoring or the firm’s record keeping.

4.  Corrective Actions

The Company must establish and implement written corrective action procedures that will go into effect if:

  • preventive controls are not property implemented;
  • there is a question regarding preventive control or food safety plan’s effectiveness;
  • the records are incomplete, or other discrepancies in implementing the food safety plan.

The corrective action procedures must include the following steps:

  • Identification of weak spots in the controls
  • Identification of ineffective controls
  • Identification of new hazards
  • Performing necessary steps to reduce the likelihood of recurrence
  • Evaluating the processed food for safety
  • Prevention of adulterated food from entering commerce

5.  Verification

HARPC requires food facilities to design and implement verification steps to ensure that their HARPC plans (including the hazard identification and analysis, preventive controls and control measures, monitoring and corrective action steps) are operating correctly to prevent or minimize food safety and adulteration hazards.  Verification steps should be sufficiently robust to ensure that:

  • The selected preventive controls are adequate
  • Monitoring is occurring properly as defined in the plan
  • Appropriate corrective actions are taken
  • Potential food and food processing hazards are reduced
  • Periodic reviews are conducted at appropriate intervals so the HARPC plan remains working and takes into account new and emerging risks and hazards

 6.  (Receiving Facilities) Supply-chain Program

HAPRC gives flexibility to receiving facilities’ controls on raw materials. If supplier or a third party entity implements controls to manage the hazards associated with raw material or other ingredients, the receiving facility does not need to establish its own preventive controls itself, but can rely on that of the third party or supplier through a risk-based supply-chain program.

Every receiving facility needs to set up a risk-based supply-chain program to make sure that the relevant hazards are appropriately controlled by its suppliers or third party entities. Under the supply-chain program, the receiving facility must first approve suppliers by considering the nature of the hazards and supplier performance. Then, the receiving facility must determine appropriate verification activities to ensure the supplier’s controls significantly minimize or prevent hazards. Appropriate verification activities may include onsite audits and testing. If the supplier is not controlling the hazards, the receiving facility can also choose to review and the verification conducted by another entity to assess the sufficiency of the controls.

In summary, the contents of the supply-chain program must include:

  • Identification and use approved suppliers
  • Determining and conducting supplier’s verification activities
  • Conducting other facility (non-supplier)’s controls of hazards, or reviewing another entity’s verification activities on the hazards.

The supply-chain program must be written. The receiving facility needs to develop written receiving procedures and document the supplier’s verification activities.

7.  Recordkeeping and Documentation

One key development under HARPC is its new requirements related to recordkeeping and methods of documentation that are now mandatory for food manufacturing, processing, packing and storage facilities.  Previously, under the Bioterrorism Act, FDA could only require a food company to maintain records that enabled food to be traced through the supply chain (one up / one back identification records). Now, HARPC and the supply-chain provisions under FSMA require that records and documents related to food hazards and process control systems be established and maintained for no less than 2 years to cover the following HARPC steps:

  • The monitoring of the preventive controls
  • The corrective actions
  • Testing results and other verification steps designed to ensure the preventive controls are effectively minimizing or preventing hazards
  • Supply-chain program
  • Trainings

In other words, FDA requires that a written record be kept of the entire plan including the process, the proof, and the problems.  A facility must make these records and documentation available to FDA upon request.

This new authority will result, eventually, in FDA demanding foreign and domestic food facilities to produce their HARPC records rather than the agency spending resources conducting physical plant inspections. The recordkeeping requirements, therefore, must tell the proper story to demonstrate HARPC compliance.

8.  Requirement to Reanalyze

After developing and implementing an adequate HARPC plan, the food facility must periodically evaluate its food safety HARPC system.  Under HARPC the facility must reanalyze its plan:

  • Whenever there is a significant change at the facility that might increase a known hazard or introduce a new one
  • Every 3 years (if no other significant changes occur)

Additionally, HARPC requires the facility to perform a new hazard analysis and implement any new, necessary preventive controls before operational changes occur.  Any changes must be documented in the firm’s HARPC records. If no changes are necessary after a reanalysis of a HARPC system, the firm must document the basis for that decision.

FAQ’s

Who is responsible for the HARPC plan?

The owner, operator, or agent in charge of each domestic or international food facility is required to develop an adequate HARPC plan for any facility that is subject to FDA food facility registration under The Bioterrorism Act. There are no substantive adulteration charges that apply to food manufactured in a facility that fails to comply with HARPC. Rather, failure to implement HARPC is defined by the FSMA as a “prohibited act”. Therefore, failure to comply could lead to criminal prosecution of the company (corporation, partnership, association, etc.) and / or the owner, operator or agent in charge of the facility.

How are HARPC and HACCP similar/different?

  • HACCP (Hazard Analysis and Critical Control Point) is the FDA’s regulatory predecessor to HARPC under FSMA.  HACCP is a very similar hazard control system, but only applies to seafood and juice processors. HARPC applies to all food facilities subject to FDA registration except those covered by and in compliance with HACCP (and a few other significant exemptions discussed below). Another significant difference is that seafood and juice HACCP were created by FDA regulation – not by federal statute. HARPC was created by an amendment to the Food Drug and Cosmetic Act, specifically, the Food Safety Modernization Act (FSMA). Although arguments could be made that seafood and juice HACCP are unconstitutional, in that they laws (legislation) created by a federal regulatory agency and not by Congress, signed by the President, those arguments do not exist for HARPC. Functionally, HACCP and HARPC are very similar, though supplier verification procedures (including the Foreign Supplier Verification Program requirements (FSVP) are much more rigorous under FSMA.

How often do I have to submit or update my HARPC plan?

  • FDA requires that a facility update its HARPC plan every 3 years or whenever there is a significant change at that facility which may increase a potential hazard or introduce a new one. Additionally, FDA may require an update based on new biological or chemical hazards.  There is no statutory requirement to submit your HARPC plan to FDA at any particular time, except, when FDA requests you to provide a copy of it. FDA would also request records necessary to demonstrate that you have properly implemented your HARPC plan. FDA’s request could be oral or in writing including during an FDA inspection.

What if I don’t have a HARPC plan? (Or my plan is inadequate?)

  • If a facility does not have a HARPC plan or if FDA determines a HARPC plan is inadequate, FDA can take a number enforcement steps. First, FDA can criminally charge a company or person for owning, operating or acting as agent in charge of a facility not in compliance with HARPC. Second, FDA can issue a public warning letter and / or place foreign firms on Import Alert.
  • If food from a non-compliant facility presents a significant food safety risk, FDA could suspend the facility’s food facility registration and thereby prevent the facility from distributing food products until FDA has approved a corrective action plan.
  • In the case of a foreign firm, FDA would likely place the facility on an Import Alert (similar to Import Alert 16-120). A firm that is listed on this Import Alert would find its food automatically detained at importation, effectively barring it from the United States market unless FDA reviews and accepts an adequate HARPC plan.

More information on HARPC and HACCP can be in found in the 2016 & 2017 KKon presentations

The Food Safety Modernization Act (FSMA), a sweeping food safety legislation amending the Food, Drug and Cosmetic Act of 1938, was enacted on January 4, 2011.  It aims to ensure the United States food supply is safe by shifting the focus from responding to contamination to preventing it. As required by FSMA, the FDA implemented the HARPC (Hazard Analysis and Risk-Based Preventive Controls) regulation (also referred to as the “Preventive Controls Rule”) for the food industry on September 17, 2015.  Compliance dates were extended for small and very small businesses:

 September 18, 2017: Small businesses (with fewer than 500 full-time employees)

September 17, 2018: Very small businesses (businesses averaging less than $1 million per year (adjusted for inflation) in annual sales 

HARPC is similar to HACCP (Hazard Analysis and Risk-Based Preventative Controls) which is mandatory for certain food categories such as seafood, juice, meat/poultry (USDA) but includes planning for potential terrorist acts or intentional adulteration requiring facility registration with the FDA, controls on transportation inbound/outbound, facility visitor access, etc.

HARPC requires virtually every food manufacturer, processer, packer, and storage facility to:

  • identify food safety and adulteration hazards associated with their foods and processes,
  • implement controls to minimize the hazards,
  • verify that the controls are working, and
  • design and implement corrective actions to address any deviations from the controls that might arise in a food safety plan.

Everything in a HARPC plan must be properly documented and must conform to FDA’s standards and definitions surrounding facilities, controls, hazards, and the adulteration of foods.  HARPC requires each food facility to document all aspects of its plan, periodically review it, constantly maintain it, and document its verification steps.

HARPC represents a substantial new regulatory requirement with an unprecedented level of coverage for the industry that must be taken seriously.  Companies must create their unique food safety plan compliant with HARPC, update it, and produce the documentation to FDA upon request or inspection.

Facility Registration

Domestic and foreign facilities that manufacture, process, pack, or hold food/beverages for human or animal consumption in the US are required to register with the FDA and renew every even-numbered year. Registration is easy and free. Follow the prompts at the link below to register your facility. Registered facilities may be subject to random inspections. 

http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ucm2006831.htm

Registration is not required for AP5 Kombucha products (aka Hard Kombucha) as the FDA does not regulate alcoholic beverages.

Current Good Manufacturing Practices (cGMP’s) – Preventative 

Controls (Critical components of Step 2 in HARPC)

Plant and Grounds

Facility exterior

  • Shouldn’t harbor pests
    • Grass/weed control
    • No stored equipment within immediate parameter
  • Protected points of entry
    • Sealed, self-closing doors
    • Screened vents at all intakes
    • Walls, roof, foundation must prevent entry of water and pests

Facility Interior

  • Walls, floors ceilings should be durable, impervious,smooth, cleanable, white or light-colored 
  • Adequate floor drainage
  • Screened windows
  • Adequate lighting and shielded bulbs
  • Adequate ventilation
  • Proper waste containment and disposal
  • Handwashing stations with dispensable soap, single-use towels, direct connection to drain, waste receptacles, signage
  • Washrooms, lunchrooms should not open directly to processing areas; negative air pressure in washrooms
  • Plumbing must have backflow devices between potable water systems and sewage lines

Receiving and Storage

  • Transportation inbound – inspect truck and materials for damage or contamination, improper temperature controls
  • Ensure Certificate of Analysis (CoA) if required or conduct inspection/testing to verify ingredients and packaging meet specifications
  • Storage
    • Insure ingredients, packaging materials, product in process, and finished product are properly stored to prevent contamination – proper temperatures, 18” from wall, 6” off floor
    • Chemicals in isolated storage – properly labeled and accessible safety data sheets (SDS)

Equipment

  • Designed, constructed and installed to be accessible for adequate cleaning, sanitation, and maintenance
  • Product contact surfaces should be smooth, non-corrosive, food-grade, non-absorbent, non-toxic, and free from cracks, crevices, and pitting
  • Must have adequate drainage
  • Establish a preventable maintenance program

Personnel

  • Establish and implement training programs for all new employees; 
    • Provide refresher training
      • Personal Hygiene
      • Allergen Standard Operating Procedures (SOP’s)
      • Product and Material Safety
  • Maintain a personal hygiene policy and enforce 
    • Hair and beard restraints
    • Clean clothing and footwear (closed-toe only)
    • Eating, drinking, and smoking in designated areas only (includes gum)
    • No jewelry, watches, earrings; no fingernail polish or artificial nails
    • Proper handwashing practices and signage
  • Only authorized personnel on-site; visitors and contract employees to sign-in
  • Employee health 
    • Inform management of any communicable disease or potential for contamination
      • Diarrhea, vomiting or other gastrointestinal illness
      • Jaundice
      • Open, blistered or infected cuts, wounds, abrasions, or burns

Sanitation and Pest Control

  • Establish procedures for cleaning and sanitation of premises, production areas, equipment, and storage areas.  
    • Document procedures, chemicals used/usage levels, and maintain a log of pre-op, periodic, and post-op sanitation.
  • Interior pest control devices must not contain bait of any kind
  • Exterior pest control devices must be tamper-resistant, locked, labeled, and secured
  • Maintain
    • List of chemicals and pesticides used (including SDS and copies of labels which includes usage/application rates)
    • Schedules/frequency
    • Usage log that lists when and where used, concentration, how it was applied and by whom
    • Location map of devices
    • Activity reports/records for findings and actions
    • Corrective action records

Traceability and Recall Protocol

  • Traceability
    • Maintain documented procedures to ensure all raw materials, product, and packaging materials can be traced to usage dae and/or lot identification
    • Finished products should carry a “use by” or “best by” date and lot number (if multiple lots per code date)
  • Consumer Complaint Log
    • Outlines how complaints are processed, evaluated and investigated
    • Document customer name, contact information, current date, name of item, a description of the product safety and/or quality complaint, the purchase date of item and possible receipt 
  • Recall Protocol
    • Document what is to be done in the event product must be recalled from the distribution system and/or shelf
    • This will allow tracing and accounting for all identified defective products in a quick and efficient manner; managing communications in the event of a recall, and assisting outside agencies by having a predetermined plan and information-gathering mechanisms

KBI will be providing checklists and templates for some of these documents – stay tuned for more resources available in the Member Forum