Regulation on the Registration and Approval Procedures of Food Establishments

PART ONE

Purpose, Scope, Basis and Definitions

Purpose

ARTICLE 1 - (1) The purpose of this Regulation is to set the procedures and principles for the registration or approval procedures of food establishments.

Scope

ARTICLE 2 - (1) This Regulation covers food establishments other than;

places where slaughter is carried out during the Feast of Sacrifice,
places of slaughter for personal needs in villages,
places of primary production for personal consumption,
places where food is prepared, processed and stored for personal consumption,
places where food is, temporarily, occasionally and on a small scale, prepared, stored and offered for charitable purposes by individual volunteers such as at charity bazaars and cultural events.

Basis

ARTICLE 3 - (1) This Regulation has been prepared on the basis of Articles 22, 30 and 31 of the Law No. 5996 on Veterinary Services, Plant Health, Food and Feed dated 11/6/2010.

Definitions

ARTICLE 4 - (1) (Amended paragraph: OG-7/1/2014-28875)(1) In addition to the definitions in Article 3 of Law No. 5996, Article 4 of the Food Hygiene Regulation published in the Official Gazette No. 28145 dated 17/12/2011, Article 4 of the Regulation on Specific Hygiene Rules for Food of Animal Origin published in the Official Gazette No. 28155 dated 27/12/2011, and Article 4 of the Regulation Laying Down Specific Rules for the Official Controls of Food of Animal Origin published in the Official Gazette No. 28145 dated 17/12/2011, the definitions in the second paragraph of this Article also apply.

(2) For the purposes of this Regulation;

Ministry: the Ministry of Food, Agriculture and Livestock,
Law: the Law No. 5996 on Veterinary Services, Plant Health, Food and Feed,
Establishment registration certificate and number: the certificate issued by the competent authority to food establishments within the scope of registration whose requested information and documents have been completed, and the number on this certificate consisting of letters and figures coded as specified in Annex-6,
Establishment approval certificate: the certificate set out in Annex-9, which may be cancelled or suspended, issued by the competent authority for the operation of a food establishment within the scope of approval whose requested information and documents have been completed and which has been found compliant as a result of the on-site official control,
Establishment approval number: the number coded as specified in Annex-12 appearing on the establishment approval certificate and the conditional approval certificate,
Establishment conditional approval certificate: the certificate set out in Annex-8, valid before the food establishment becomes operational and until the approval certificate is issued, for a food establishment whose requested information and documents have been completed and which has been determined to meet the building, infrastructure and equipment requirements as a result of the on-site official control,
Food establishment: any establishment, whether for profit or not, operated by public institutions and organizations or by natural or legal persons, carrying out any activity related to any stage at which food is produced/processed/preserved/stored/distributed/transported/sold/served,
Facility: any unit within a food establishment,
Competent Authority: the Provincial Directorate of the Ministry in carrying out the work and procedures within the scope of this Regulation, the District Directorate of the Ministry where authorized by the Provincial Directorate, and the Ministry in the examination and inspection of these works and procedures,
(Added: OG-7/1/2014-28875)(1) Food production place: the entirety of the facilities where one or more of the operations of storage, sorting, processing, evaluation, preservation and packaging of food materials is carried out starting from the raw material and where they are stored to be sent to food sales points, together with the places to be considered as complementary to these facilities,
(Added: OG-7/1/2014-28875)(1) Food sales place: the places where wholesale or retail distribution and sale of all kinds of raw, semi-finished and finished food materials is carried out and where these are stored for sale,
(Added: OG-7/1/2014-28875)(1) Mass consumption place: the places where food materials are processed and produced in accordance with their technique and offered for consumption in the same location.

PART TWO

Registered Food Establishments, Registration Procedures and Principles

Registered food establishments

ARTICLE 5 - (1) Establishments other than those specified in Annex-1 are within the scope of registration.

(2) (Repealed: OG-10/1/2013-28524)

Registration procedures and principles

ARTICLE 6 - (1) (Amended paragraph: OG-10/1/2013-28524) Operators of warehouses, retail and mass consumption establishments apply to the competent authority with the information and documents in Annex-2; operators of food-producing establishments apply with the information and documents in Annex-3.

(2) (Amended paragraph: OG-7/1/2014-28875)(1) The application is examined by the competent authority within fifteen working days. If the information and documents have been prepared completely, the establishment registration certificate set out in Annex-5 is issued to food establishments by the competent authority, indicating the lines of activity set out in Annex-14.

(3) If the information and documents in the file have been prepared incompletely or incorrectly, the file is returned to the applicant by official letter, indicating the deficiency or error.

(4) The establishment registration certificate is valid for the trade name, natural and legal person, establishment address and field of activity written on it. If any of this information changes, the registration certificate loses its validity. In cases of change, the food business operator applies in writing to the competent authority within three months at the latest, attaching the relevant information and documents and the original of the establishment registration certificate to a petition. The establishment registration certificate is reissued by the competent authority after the relevant change has been made.

(5) Food business operators are obliged, in case they stop all or part of their activities, to notify this situation to the competent authority within three months and to ensure that the competent authority has up-to-date information about the establishment.

(6) The food business operator;

in case the establishment registration certificate is lost, applies to the competent authority by attaching to a petition the original of the newspaper in which the invalidity of the certificate was announced, by placing a loss notice in one of the newspapers published nationwide or locally,
in case the establishment registration certificate is damaged so as to be illegible, applies to the competent authority by attaching the original of the damaged certificate to a petition. If the competent authority finds it appropriate, the establishment registration certificate is reissued.

(7) The Ministry creates a list for registered food establishments and keeps these lists up to date.

PART THREE

Approval Procedures and Principles of Food Establishments Subject to Approval

Food establishments subject to approval

ARTICLE 7 - (1) The food establishments subject to approval listed in Annex-1 of this Regulation are obliged to obtain a conditional approval certificate before becoming operational, and an approval certificate thereafter.

(2) (Added: OG-7/1/2014-28875)(1) Among the food establishments subject to approval listed in Annex-1, activities within the scope of local, marginal and limited activity are considered retail activity. These establishments are within the scope of establishments subject to registration.

(3) (Added: OG-7/1/2014-28875)(1) The procedures and principles relating to local, marginal and limited activity are regulated by communique.

Approval procedures and principles

ARTICLE 8 - (1) Food business operators apply to the competent authority with the information and documents specified in Annex-7 of this Regulation in order to obtain approval for their establishments subject to approval.

(2) The competent authority examines the application file within fifteen working days from the date of application;

If the information and documents have been prepared incompletely or incorrectly, the deficiencies are notified to the applicant by the competent authority by official letter. A file whose deficiencies are not completed within one month is returned to the applicant.
If the information and documents are complete and correct, within twenty working days the establishment is subjected to on-site official control by control officers as to its compliance with the provisions specified in the relevant articles of the Law and with the provisions on building, infrastructure and equipment requirements set out in the Food Hygiene Regulation and the Regulation on Specific Hygiene Rules for Food of Animal Origin.

(3) (Amended: OG-10/1/2013-28524) As a result of the on-site official control;

If the establishment is found non-compliant, the application file is returned to the food business operator, indicating the deficiencies of the establishment.
If the establishment is found compliant, the establishment conditional approval certificate in Annex-8 and the establishment approval number are issued to the food establishment.

(4) In a second on-site official control carried out within three months after the issuance of the establishment conditional approval certificate and the establishment approval number;

If it is determined that the food establishment meets the provisions specified in the relevant articles of the Law together with the provisions in the Food Hygiene Regulation, the Regulation on Specific Hygiene Rules for Food of Animal Origin, the Regulation Laying Down Specific Rules for the Official Controls of Food of Animal Origin, and the Regulation on the Official Controls of Food and Feed, the establishment conditional approval certificate is converted into the establishment approval certificate in Annex-9.
If it is determined that, although significant progress has been made in the establishment, the legislative provisions specified in subparagraph (a) of the fourth paragraph are not fully met, the competent authority may extend the conditional approval period of the establishment. However, the conditional approval period may not exceed six months in total. If, at the end of the period or periods granted for the extension of the conditional approval, it is determined that the establishment fully meets the legislative provisions specified in subparagraph (a) of the fourth paragraph, the establishment conditional approval certificate issued to the establishment is converted into the establishment approval certificate. If, in the official control carried out at the end of the extended conditional approval period, it is determined by the competent authority that the establishment does not fully meet the legislative provisions specified in subparagraph (a) of the fourth paragraph, the establishment conditional approval certificate is cancelled and the activity of the establishment is stopped.

(5) The conditional approval period to be granted for vessels with freezer units and factory vessels flying the flag of our country may not exceed twelve months in total.

(6) The Ministry creates lists for approved establishments, keeps the lists up to date and publishes them in the form set out in Annex-13.

Conditions of validity of the establishment approval certificate and number

ARTICLE 9 - (1) The competent authority reviews the approval conditions of the establishment while carrying out official controls.

(2) Where it is determined that the approval conditions of a food establishment subject to approval no longer continue;

The competent authority grants the food business operator a period not exceeding six months to remedy the deficiencies identified, except in situations posing a danger to human health and food safety and requiring urgent measures. If the non-conformities are not remedied at the end of the period granted, the approval of the establishment is suspended or the activity of the section where the non-conformity exists is stopped. If the non-conformities of the establishment whose approval is suspended or the section whose activity is stopped are not remedied within one year, the establishment approval certificate and the establishment approval number issued are cancelled by the competent authority.
If the competent authority identifies deficiencies posing a danger to human health and food safety and requiring urgent measures, it suspends the approval of the establishment or stops the activity of the section where the non-conformity exists. If the non-conformities of the establishment whose approval is suspended or the section whose activity is stopped are not remedied within one year, the establishment approval certificate and the establishment approval number issued are cancelled by the competent authority.
A food establishment whose approval is suspended may not operate.

(3) The establishment approval certificate is valid for the trade name, natural or legal person, establishment address and field of activity written on it. If any of this information changes, the establishment approval certificate loses its validity. In cases of change, the food business operator applies to the competent authority within three months, attaching the necessary information and documents together with the original of the establishment approval certificate to a petition. The competent authority reissues the approval certificate if it finds it appropriate.

(4) The food business operator,

in case the establishment approval certificate is lost, applies by attaching to a petition the original of the newspaper in which the invalidity of the certificate was announced, by placing a loss notice in one of the newspapers published nationwide,
in case the establishment approval certificate is damaged so as to be illegible, applies to the competent authority by attaching the original of the damaged certificate to a petition. If the competent authority finds it appropriate, the establishment approval certificate is reissued.

(5) The food business operator is obliged to notify the competent authority within three months that it has stopped all or part of its activity. If the food business operator wishes to bring all or part of its establishment back into operation, an on-site official control is carried out by the competent authority, and if found compliant, the operation of all or part of the establishment is permitted.

PART FOUR

Personnel Required to Be Employed

Personnel required to be employed

ARTICLE 10 - (1) The following matters apply to the personnel required to be employed in food establishments.

(Repealed: OG-7/1/2014-28875)(1)
If the food business operator has received education at least at undergraduate level appropriate to the type of production, he may work as required personnel in his own establishment.
The food business operator may employ separate personnel for each activity in his establishment, or may employ only one person. If only one person is employed, personnel who are members of a profession appropriate to all activities is employed.
If the food business operator carries out more than one activity at the same address, he is obliged to employ the personnel required to be employed if the total motor power of the tools and equipment used in all activities is over 30 horsepower or the total number of personnel employed is more than ten persons.
(Amended: OG-7/1/2014-28875)(1) Food business operators are obliged to ensure that the competent authority has up-to-date information regarding the change of the personnel required to be employed in case such personnel are dismissed or leave for any reason.
The food business operator is obliged to employ required personnel according to the working days and hours during which the establishment is in operation. The required personnel working in the food establishment may not work in another job during the working days and hours in which the establishment is in operation.

PART FIVE

Assignment of Official Veterinarian, Authorized Veterinarian and Official Auxiliary

Assignment

ARTICLE 11 - (1) Following the granting of conditional approval to slaughterhouses, cutting plants and game-handling plants, the competent authority;

(Amended: OG-7/1/2014-28875)(1) assigns at least one official or authorized veterinarian to slaughterhouses. The working hours of the official or authorized veterinarian at the slaughterhouse are determined taking into account the working days and hours of the slaughterhouse.
(Amended: OG-7/1/2014-28875)(1) assigns an official or authorized veterinarian to cutting plants and game-handling plants, taking into account the working hours, the number of shifts and the capacities. The frequency of the official controls to be carried out by the official or authorized veterinarian at the establishment is determined so as to also cover risk-based official controls.
If the slaughterhouse and the cutting plant operate at the same address, the same official or authorized veterinarian may be assigned to both facilities.

(2) In accordance with the Regulation Laying Down Specific Rules for the Official Controls of Food of Animal Origin, the competent authority may assign in slaughterhouses an official auxiliary having the characteristics to carry out the necessary activities, to work under the authority and responsibility of the official veterinarian.

(3) An official or authorized veterinarian previously assigned to an establishment whose activity has been stopped by the food business operator or the competent authority is withdrawn by the competent authority. If the establishment is to be brought back into operation and is found compliant as a result of the on-site official control, an official or authorized veterinarian is reassigned to the establishment.

PART SIX

Miscellaneous and Final Provisions

Exceptional provisions

ARTICLE 12 - (1) For the food establishments specified below, the permit certificate/registration printouts obtained in accordance with the procedure from the relevant institutions are accepted in place of the establishment registration certificate.

Portable and/or temporary food establishments such as tents, kiosks and mobile sales vehicles.
Places where the producer directly supplies small quantities of primary products to the final consumer or to local retailers selling directly to the final consumer.
Places where the producer directly supplies poultry and lagomorph meat slaughtered on the farm, in small quantities and as raw meat, to the final consumer or to local retailers selling directly to the final consumer.
Hunters who supply small quantities of wild game animals or wild game meat directly to the final consumer or to local retailers selling directly to the final consumer.
(Added: OG-7/1/2014-28875)(1) Fishing vessels and boats used in fishing and aquaculture farms.

(2) The permit certificate/registration printouts specified in the first paragraph must be presented to the Ministry if requested.

Other provisions

ARTICLE 13 - (1) (Repealed: OG-10/1/2013-28524)

(2) (Amended paragraph: OG-10/1/2013-28524) The establishment registration and approval certificates issued to food establishments within the scope of the Law are certificates issued within the scope of the Food Hygiene Regulation published in the Official Gazette No. 28145 dated 17/12/2011, the Regulation on Specific Hygiene Rules for Food of Animal Origin published in the Official Gazette No. 28155 dated 27/12/2011, the Regulation Laying Down Specific Rules for the Official Controls of Food of Animal Origin published in the Official Gazette No. 28145 dated 17/12/2011, and the Regulation on the Official Controls of Food and Feed published in the Official Gazette No. 28145 dated 17/12/2011. Obtaining these certificates does not remove the obligation to obtain the permits or licences issued by other public institutions and organizations in accordance with the relevant legislation.

(3) The production permit certificates of food and of materials and articles in contact with food have been cancelled with all their consequences.

Transitional provisions

PROVISIONAL ARTICLE 1 - (Amended: OG-7/1/2014-28875)(1)

(1) Among the food establishments subject to approval operating with a working permit certificate, working permit and food registry certificate, or a certificate equivalent to these certificates obtained before 17/12/2011, food establishments that submitted a modernization plan by 31/12/2012 but could not complete the investment in the modernization plan by 31/12/2013, together with food establishments whose activity was stopped because they did not comply with the stages in the modernization plan despite having submitted one, may, if they apply by 15/2/2014 and are found appropriate by the competent authority, be granted additional time until 31/12/2014 to complete their investments.

(2) Food establishments within the scope of registration that obtained a working permit and food registry certificate, a registration certificate or a certificate equivalent to these certificates before 17/12/2011 and are still operating are obliged to replace these certificates with the registration certificate in this Regulation by 31/12/2014 at the latest.

(3) Milk collection centres registered in the milk registration system that could not obtain an approval certificate by 31/12/2013 are obliged to obtain an approval certificate by 31/12/2014.

Entry into force

ARTICLE 14 - (1) This Regulation enters into force on the date of its publication.

Execution

ARTICLE 15 - (1) The provisions of this Regulation are executed by the Minister of Food, Agriculture and Livestock.