Hi All,
firstly let me express my emotions ... I do really like this site and the attitude of all taking part in making this site professional.
As I am this is my first topic, apologise if not fully understandable.
I would like to ask for an opinion regarding TAMC levels in food supplements. our client is checking results against Ph.Eur. v8. As we are a food producer in terms of legislation I did argue about the limits given as 2000 CFU/g. But in food legislation i did not find requirements for food supplements for TVC or TAMC (might be the same if I am not wrong).
Secondly could someone advise me if result 3000 CFU/g how big hazard represents?
Thank you,
Zoltan
Hi Zoltan,
Yr English is fine.
Food Supplements not my area but analytical requirements typically depend on -
(a) Local (or Destination) Regulatory requirements
(b) Your Product specification as agreed with customer.
TAMC, apparently, = total aerobic microbial count
This may or may not be identical to TVC depending on the Procedure details.for each.
JFI, USFDA have -
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION
PART 111 -- CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS
Subpart K--Production and Process Control System: Requirements for Manufacturing Operations
Sec. 111.365 What precautions must you take to prevent contamination?
You must take all the necessary precautions during the manufacture of a dietary supplement to prevent contamination of components or dietary supplements. These precautions include:
(a) Performing manufacturing operations under conditions and controls that protect against the potential for growth of microorganisms and the potential for contamination;
(b) Washing or cleaning components that contain soil or other contaminants;
© Using water that, at a minimum, complies with the applicable Federal, State, and local requirements and does not contaminate the dietary supplement when the water may become a component of the finished batch of dietary supplement;
(d) Performing chemical, microbiological, or other testing, as necessary to prevent the use of contaminated components;
etc
The EU also discuss micro requirements but not quantitatively afai can see for TAMC, eg
EU Quality Guide for Food Supplements,2007.pdf 314.18KB
15 downloads
Aerobic Plate Count is not usually regarded as a HACCP Food Safety hazard.
Here is Polish Regulation, 2015 whch contains some micro numbers including TAMC from "customer"
Poland, micro.Quality food supplements,2015.pdf 41.91KB
11 downloads
