Institution: Ministry of Food, Agriculture and Livestock

Date of Approval: 29.12.2011

Official Gazette Date: 29.12.2011

Official Gazette No: 28157 (3rd Repeated)

CHAPTER ONE: Purpose, Scope, Basis and Definitions

Purpose

ARTICLE 1 - (1) The purpose of this Regulation is to determine the microbiological criteria of foods and the rules that food business operators must comply with and implement.

Scope

ARTICLE 2 - (1) This Regulation covers the microbiological criteria of foods and the rules that food business operators must comply with and implement.

(2) This Regulation applies provided that the provisions related to;

  • a) The health standards of foods included in the Regulation on Special Hygiene Rules for Animal Foods published in the Official Gazette dated 27/12/2011 and numbered 28155, where other special rules for the control of microorganisms are determined,
  • b) The parasites included in the Regulation Determining Special Rules for Official Controls of Animal Foods published in the Official Gazette dated 17/12/2011 and numbered 28145,
  • c) The microbiological criteria included in the Regulation on Waters Intended for Human Consumption published in the Official Gazette dated 17/2/2005 and numbered 25730,

are reserved.

Basis

ARTICLE 3 - (1) This Regulation is prepared;

  • a) Based on articles 21, 22, 23, 24, 29, 30, 31, 32 and 34 of the Veterinary Services, Plant Health, Food and Feed Law No. 5996 dated 11/6/2010,
  • b) In parallel with the European Union Commission Regulation No. 2073/2005/EC on Microbiological Criteria for Foodstuffs.

Definitions

ARTICLE 4 - (1) In addition to the definitions in article 3 of Law No. 5996, the definitions in the second paragraph are also valid.

(2) In this Regulation;

  • a) Ministry: Ministry of Food, Agriculture and Livestock,
  • b) Infant foods: Foods produced to meet the special nutritional needs of infants defined as the age group under twelve months,
  • c) Food safety criterion: The criterion applied to products on the market that defines the acceptability of a product or a batch of food,
  • ç) Microorganisms and their toxins and metabolites: Bacteria, viruses, yeasts, molds, algae, parasitic protozoa, microscopic parasitic helminths and their toxins and metabolites,
  • d) Microbiological criterion: The criterion based on determining the presence/absence or number of microorganisms or the amount of their toxins and metabolites per mass, volume, area, batch or unit, used to determine the acceptability of a food, a batch of food or a process,
  • e) Compliance with microbiological criteria: Achieving the suitable or acceptable results in Annex-1 and Annex-2 during sampling, analysis and corrective actions according to Law No. 5996, related legal regulations and Ministry instructions,
  • f) Sample: A set consisting of one or more units selected by different methods from a large batch or material to provide information about a specific characteristic of that batch or material and to serve as a basis for decisions about the process in which they are produced,
  • g) Foods for special medical purposes: Foods prepared to meet the nutritional requirements of individuals affected by disease, disorder or medical condition or with nutritional disorders for these reasons, which must be used under medical supervision,
  • ğ) Batch: A group or set of products obtained from a specific process under the same conditions and produced in a defined production period at a specific place,
  • h) Shelf life: The period compatible with the expiration date or recommended consumption date defined in the Turkish Food Codex Labeling Regulation,
  • ı) Representative sample: A sample that carries the characteristics of the batch it is taken from, having the same probability as the initial sample randomly selected from each part or primary sample of the batch,
  • i) Ready-to-eat food: Food produced by the food business operator to be offered directly for human consumption without the need for cooking or any other process that would reduce or eliminate the microbial load,
  • j) Production hygiene criterion: An indicator contamination value showing the acceptability of the production process, not applied to products on the market, where values above this criterion require corrective actions to ensure production hygiene compliant with Law No. 5996.

CHAPTER TWO: General Provisions

General provisions

ARTICLE 5 - (1) The food business operator is responsible for ensuring compliance of foods with the microbiological criteria specified in Annex-1 and Annex-2.

The food business operator at each stage of production, processing and distribution including retail sales;

  • a) Ensures compliance with the production hygiene criteria in Annex-2 during the supply, transportation and processing of food and raw materials,
  • b) Takes measures as part of procedures based on good hygiene practices determined in the Food Hygiene Regulation published in the Official Gazette dated 17/12/2011 and numbered 28145, together with hazard analysis and critical control points (HACCP) principles, to ensure compliance with food safety criteria in Annex-1 applied throughout the product's shelf life considering the intended conditions of distribution, storage and use.

(2) The Ministry has the right to take more detailed samples and analyses for microorganisms and their toxins and metabolites not included in Annex-1 for foods suspected of being unreliable, to verify the suitability of the process or within the scope of risk analysis. For this purpose, the criteria in Annex-3 are considered.

(3) The food business operator is responsible for ensuring sampling according to the rules specified in Annex-4 to ensure compliance with the production hygiene criteria in Annex-2.

(4) The food business operator may also use good hygiene practice guides issued by the Ministry to fulfill the obligations of this Regulation.

Analyses related to criteria

ARTICLE 6 - (1) The food business operator ensures the implementation of appropriate analysis methods for the microbiological criteria in Annex-1 and Annex-2 to demonstrate or confirm that their procedures based on good hygiene practices and HACCP principles are effective.

(2) The food business operator decides the most appropriate sampling frequency, not less than the number of samples specified in Annex-1 and Annex-2. This decision is made according to procedures based on good hygiene practices and HACCP principles, also considering the consumption instructions of the food.

(3) Sampling frequency can be determined according to the size, characteristics and structure of the food business so that food safety is not compromised.

(4) For foods within the scope of this Regulation, the number of samples specified as (n) in Annex-1 is taken. However, one sample is taken from food sales and mass consumption places and evaluated according to the "M" value.

CHAPTER THREE: Special Provisions for Sampling and Analysis Methods

Sampling and analysis methods

ARTICLE 7 - (1) Sampling plans and analysis methods specified in Annex-1 and Annex-2 are used as reference methods.

(2) When sampling is required to guarantee compliance with criteria, samples are taken from production areas and equipment used in production. Accordingly;

  • a) ISO 18593 standard is used as the reference method for sampling.
  • b) Food business operators producing ready-to-eat foods that may pose a Listeria monocytogenes risk take samples from production areas and equipment as part of sampling plans.
  • c) Food business operators producing dried infant formulas or dried foods for special medical purposes for infants under six months take samples from production areas and equipment for Enterobacteriaceae as part of sampling plans for Cronobacter sakazakii risk.

(3) If the food business operator can demonstrate effective production based on HACCP principles with retrospective records, the number of samples in the sampling plans specified in Annex-1 and Annex-2 may be reduced.

(4) If the purpose of the analysis is to determine the acceptability of a process or a batch of food, the sampling plans specified in Annex-1 and Annex-2 are accepted as the minimum number.

(5) The food business operator may use other sampling and analysis methods than those specified in this Regulation. However, in this case, the operator must prove to the Ministry official that the methods used provide at least equivalent guarantees. Accordingly;

  • a) These methods may include alternative sampling stages and the use of new analysis methods.
  • b) Microorganisms and related microbiological limits not included in Annex-2, as well as non-microbiological analyses, are only permitted for production hygiene criteria.
  • c) The use of alternative analysis methods is accepted if they are approved against the reference methods given in Annex-1 and Annex-2 and are certified registered methods according to protocols included in EN/ISO 16140 standard or other internationally recognized similar standards.
  • ç) If the food business operator wishes to use analysis methods other than the approved and certified methods defined in item (c), these methods are approved according to internationally accepted protocols and their use is authorized by the Ministry.

CHAPTER FOUR: Special Provisions

Non-compliant results

ARTICLE 8 - (1) If analysis results do not comply with the criteria specified in Annex-1 and Annex-2, the food business operator takes the corrective actions defined in their HACCP-based procedures and other necessary actions to protect consumer health, along with the measures specified in paragraphs two, three and four.

(2) The food business operator takes measures including the development of HACCP-based procedures or other good hygiene practices to identify the cause of non-compliant results and prevent reoccurrence of microbiological contamination.

(3) If the food safety criteria in Annex-1 are not met, the product or batch is recalled or withdrawn according to article 22 of Law No. 5996. However, provided that it is done only by the food business operator producing the food;

  • a) Products placed on the market but not yet at the retail stage and not meeting food safety criteria may be subjected to additional processes to eliminate the hazard.
  • b) If it does not pose a risk to human or animal health, is included in procedures based on good hygiene practices and HACCP principles, and is permitted by the Ministry, a batch may be used for a purpose other than the initially intended one.

(4) If production hygiene criteria are not met, the measures specified in Annex-2 are taken.

Labeling

ARTICLE 9 - (1) In minced meat, prepared meat mixtures and meat products produced and marketed to be consumed cooked, which meet the necessary conditions for Salmonella in Annex-1 and Annex-2, the producer clearly labels that the product must be fully cooked before consumption to inform the consumer.

CHAPTER FIVE: Miscellaneous and Final Provisions

Administrative sanctions

ARTICLE 10 - (1) Administrative sanctions are applied to those who act contrary to this Regulation according to the relevant articles of Law No. 5996.

Compliance obligation

PROVISIONAL ARTICLE 1 - (1) Food business operators operating before the publication date of this Regulation must comply with the provisions in Annex-2 and Annex-4 envisaged by this Regulation by 31/12/2013.

Entry into force

ARTICLE 11 - (1) This Regulation enters into force on the date of its publication.

Execution

ARTICLE 12 - (1) The provisions of this Regulation are executed by the Minister of Food, Agriculture and Livestock.

NOTE: FOR ANNEXES, PLEASE REFER TO THE OFFICIAL GAZETTE