Supplementary Foods Legislation
May 2, 2013 THURSDAY
Official Gazette
Number: 28635
REGULATION
From the Ministry of Food, Agriculture, and Livestock:
REGULATION ON THE IMPORT, PRODUCTION, PROCESSING, AND MARKET PLACEMENT OF SUPPLEMENTARY FOODS
CHAPTER ONE
Purpose, Scope, Basis, and Definitions
Purpose
Article 1 – (1) The purpose of this Regulation is to determine the procedures and principles regarding the import, production, processing, and market placement of supplementary foods.
Scope
Article 2 – (1) This Regulation covers the registration of businesses that import, produce, process, and market supplementary foods; the import, production, processing, and market placement of supplementary foods; the approval, traceability, and workplace responsibilities of supplementary foods, and the establishment, working procedures, and principles of the Supplementary Food Commission.
Basis
Article 3 – (1) This Regulation is prepared based on Article 28 of the Veterinary Services, Plant Health, Food, and Feed Law No. 5996 dated 11/6/2010.
Definitions
Article 4 – (1) In addition to the definitions in Article 3 of Law No. 5996, the definitions in the second paragraph also apply.
(2) In this Regulation:
a) Domain name: The domain name of internet publications exemplified as www.abcd.com,
b) Ministry: Ministry of Food, Agriculture, and Livestock,
c) Direct seller: Independent persons who offer supplementary foods purchased from food businesses they have contracts with for direct sales to consumers on their own account without being bound by an employment contract,
d) Labeling: Any text, information, trademark, brand name, pictorial element, or sign related to food presented with the food or on materials such as packaging, documents, notifications, labels introducing the food,
e) Food operator: Any natural or legal person responsible for ensuring that the activities carried out at any stage of production, import, processing, and market placement of food comply with the provisions of the legislation, whether profit-oriented or not, including public institutions and organizations,
f) Provincial directorate: Provincial directorates of the Ministry,
g) Processing: Any process that fundamentally changes the initial product, including thermal processing, smoking, curing, maturing, drying, marination, extraction, extrusion, or the application of one or more of these,
h) Law: Veterinary Services, Plant Health, Food, and Feed Law No. 5996,
i) Market placement: The supply of supplementary foods to the market, whether for a fee or free of charge,
j) Supplementary food: Products prepared in capsule, tablet, lozenge, single-use powder package, liquid ampoule, dropper bottle, and other similar liquid or powder forms, containing concentrated or extract forms of nutrients such as vitamins, minerals, proteins, carbohydrates, fiber, fatty acids, amino acids, or other substances with nutritional or physiological effects of plant, herbal, and animal origin, bioactive substances and similar substances, with a determined daily intake dose, aimed at supplementing normal nutrition,
k) Supplementary Food Commission (TEGK): The Commission composed of representatives specified in Article 5,
l) URL address: The full web address where information about the supplementary food is located, exemplified as “http://www.abcd.com/abcdefgh.htm“,
m) Competent authority: Provincial directorates in the field for the execution of tasks and procedures under this Regulation, and the General Directorate of Food and Control for inspections and audits.
CHAPTER TWO
Establishment of the Supplementary Food Commission and Expert Database
Establishment of the Supplementary Food Commission
Article 5 – (1) The TEGK consists of fifteen members experienced in supplementary foods, including six representatives from the Ministry, three representatives from the Ministry of Health, and three scientists selected separately by both Ministries who are distinguished in their field.
(2) The presidency of the TEGK is conducted by a representative of the Ministry. If the president does not attend the meeting, the TEGK members elect a temporary president from among themselves for that meeting only.
(3) The president of the TEGK and the appointed commission members are approved by the Ministry.
(4) The secretariat of the TEGK is carried out by the Ministry.
(5) The term of office for TEGK members is three years from the date of appointment. If requested by the member and deemed appropriate by the Ministry, the term of office may be extended for a maximum of two more terms.
Duties, Authorities, and Responsibilities of the Supplementary Food Commission
Article 6 – (1) The duties of the TEGK are as follows:
a) The evaluation of supplementary foods consisting of a single plant listed as positive on the Ministry’s plant list or consisting of a single ingredient with limits specified in the relevant legislation is outside the scope of the TEGK.
b) For supplementary foods to be imported, produced, processed, and composed of ingredients permitted for use in the relevant legislation, other than those specified in clause (a), the TEGK decides whether the product is a supplementary food and conducts a risk assessment, presenting the evaluation result to the Ministry.
c) Determine the working methods of the commission.
d) Propose changes to the Ministry regarding the number of members and scientists in line with technical and scientific developments.
(2) TEGK members must be independent while performing their duties under this Regulation. The scientists who are TEGK members submit the General Declaration in Annex-4 to the Ministry, declaring their independence and impartiality in their duties under this Regulation.
(3) TEGK members cannot delegate their duties, authorities, and responsibilities to another member or third party.
(4) The TEGK may collaborate with similar national and international organizations conducting risk assessments on matters within the scope of this Regulation.
Meeting and Decision-Making Procedure of the Supplementary Food Commission
Article 7 – (1) The TEGK holds at least twelve regular planning and evaluation meetings per year. If necessary, the TEGK can hold a meeting upon the invitation of the President.
(2) If TEGK members have excuses other than health reports and temporary assignments, they must notify the TEGK President in writing. In emergencies, notification can be made to the President through other communication means, provided that written notification is made later.
(3) The membership of a member who does not attend three consecutive meetings without excuse within a year is terminated with the approval of the Ministry.
(4) The TEGK meets with the absolute majority of the total number of members with an agenda. Meeting decisions are taken by the absolute majority of the members attending the meeting. If there is a tie in the votes, the opinion of the President is considered the majority. TEGK members cannot abstain from voting. Minutes are prepared regarding the decisions taken.
(5) After the meeting or meetings, the draft scientific opinion is prepared by the President. Opinions of all members are obtained through the secretariat. In case of dissenting opinions, they are justified in writing, and the final scientific opinion is formed by the absolute majority of the members.
(6) The final scientific opinion, signed by all members, with written objections if any, is submitted to the Ministry.
(7) The TEGK evaluates any new data and scientific information obtained or arising after the final opinion and forms a new scientific opinion if necessary.
(8) The Ministry may request the re-evaluation of a previously formed scientific opinion.
(9) If a member’s term ends for any reason such as termination of membership, resignation, or death, a new member is appointed with the approval of the Ministry. The term of office for the new member ends with the term of the other members.
Expert Database
Article 8 – (1) The Ministry creates a Supplementary Food Expert Database containing the fields of expertise and contact information of experts to provide expert support for the TEGK’s work under this Regulation.
(2) The TEGK can consult experts in the Supplementary Food Expert Database and invite experts to provide scientific and/or technical support on specific issues if needed.
CHAPTER THREE
General Provisions, Responsibilities, Registration Procedures and Principles, Production, Processing, Import and Approval, Market Placement
General Provisions
Article 9 – (1) The import, production, processing, and market placement of supplementary foods are carried out in accordance with the provisions of this Regulation.
(2) Food operators within the scope of this Regulation must comply with the provisions of the legislation related to supplementary foods.
(3) The food operator applies to the provincial directorate with the prepared file for supplementary foods to be evaluated by the TEGK or the provincial directorate. The provincial directorate examines whether there are any advertisements and promotions related to the supplementary foods for which the food operator has applied in all media. If the food operator has initiated legal procedures to remove advertisements and promotions made contrary to the legislation, the application is accepted, and the file is examined. Otherwise, the file is returned to the food operator by the provincial directorate with an official letter.
(4) If advertisements and promotions contrary to the legislation are made for supplementary foods produced and/or imported and/or processed by the food operator in all media other than the domain name and URL address reported to the provincial directorate, administrative sanctions are applied to the food operator and supplementary foods in accordance with the relevant legislation.
(5) The list of approved supplementary foods and the food businesses producing, processing, and importing these foods are updated and published on the Ministry’s official website.
Responsibilities
Article 10 – (1) The food operator is responsible for ensuring and verifying compliance with the conditions specified in the Law at every stage of their activity.
(2) If the food operator evaluates that the supplementary food produced, processed, imported, or placed on the market does not comply with food safety conditions or has reasonable grounds for this, they must immediately start the necessary procedures for the recall of the food from the stage it leaves their control and inform the competent authority. The food operator must accurately and effectively inform the consumer or user about the reason for the recall and call for the return of the food if the supplementary foods need to be recalled.
(3) The food operator must keep the required records related to their activity up-to-date and present them to the competent authority upon request.
(4) The food operator is responsible for preventing, reducing, or eliminating risks related to supplementary food and collaborates with the competent authority in taking such measures. The food operator cannot obstruct the implementation of measures taken by the Ministry.
(5) Supplementary foods cannot be produced, processed, imported, or placed on the market without approval.
(6) The food operator must import, produce, process, and place on the market the supplementary foods approved by the Ministry.
(7) If supplementary foods are sold to the consumer at their home, workplace, or another place not belonging to the seller through explanation and/or demonstration by the direct seller, both the direct seller and the contracting operator are jointly responsible for any liability arising.
Registration Procedures and Principles
Article 11 – (1) Supplementary food businesses are registered according to the provisions of the Regulation on Registration and Approval Procedures of Food Businesses published in the Official Gazette No. 28145 dated 17/12/2011.
(2) In addition to the provisions of the Regulation specified in the first paragraph, food operators present documents and/or documents showing that they apply a procedure based on the principles of hazard analysis and critical control points with domain name and/or URL address information to the competent authority.
Production, Processing, Import, and Approval of Supplementary Food
Article 12 – (1) Food operators apply to the provincial directorate with the documents specified in Annex-1 for the production, processing, and import of supplementary food to be evaluated by the TEGK, with the documents specified in Annex-2 for those previously approved for production, processing, and import where the name and brand of the supplementary food have changed, but the ingredients and food operator remain the same, and with the documents specified in Annex-3 for those specified in the first paragraph (a) of Article 6.
(2) The information and documents specified in Annex-1, Annex-2, and Annex-3 are examined by the provincial directorate.
a) If the information and documents in the file are incomplete or incorrectly prepared, the file is returned to the applicant with an official letter indicating the deficiency or incorrectness.
b) If the information and documents are complete and correct:
- Supplementary foods specified in the first paragraph (a) of Article 6 are evaluated by the provincial directorate. If the result is positive, the supplementary food is approved by the provincial directorate, and the result is notified to the food operator with the provincial directorate’s official letter.
- If the evaluation result by the provincial directorate is negative, the file is returned to the food operator with an official letter indicating the reason for non-compliance.
(3) The information and documents related to supplementary foods specified in the first paragraph (b) of Article 6 are sent to the Ministry for evaluation by the provincial directorate. The Ministry;
a) If the information and documents in the file are incomplete or incorrectly prepared, the file is returned to the provincial directorate to be returned to the food operator with an official letter indicating the deficiency or incorrectness.
b) If the information and documents are complete and correct, the file is sent to the TEGK for evaluation. If the evaluation result by the TEGK is positive and deemed appropriate by the Ministry, the result is notified to the provincial directorate with an official letter. The supplementary foods to be produced, processed, or imported are approved by the provincial directorate, and the result is notified to the food operator with the provincial directorate’s official letter.
(4) The Ministry returns the file to the provincial directorate to be returned to the food operator with an official letter indicating the deficiency or incorrectness if the information and documents in the file are incomplete or incorrect or if the evaluation result by the TEGK is negative.
(5) If the name and brand of the supplementary food, previously approved for production, processing, and import specified in the first paragraph (a) and (b) of Article 6, have changed, but the producer, processor, or importer and the ingredients remain the same, the food operator applies to the provincial directorate with the documents specified in Annex-2. The provincial directorate evaluates the changes. If the evaluation result is positive, the supplementary food is approved by the provincial directorate, and the result is notified to the food operator with the provincial directorate’s official letter.
Market Placement of Supplementary Food
Article 13 – (1) Supplementary foods must be offered for sale at the importer, producer, or processor’s sales place, food businesses where they are placed on the market, or wholesale warehouses of these businesses, or at the domain name and URL address or addresses declared by the food operator, or by the direct seller with whom the food operator has a contract.
CHAPTER FOUR
Traceability, Precautionary Measures, Official Control, and Labeling
Traceability
Article 14 – (1) Food operators;
a) Must establish traceability at all stages of raw material supply, import, production, processing, and market placement to detect any substance prescribed or expected to be found in the animal, plant, or food from which the supplementary food is obtained.
b) Must review the traceability system, verify that it is working, and record it.
c) Must identify any substance that may be found in the content of the animal, plant, or food from which the supplementary food is obtained, the source from which it is supplied, and the places where it is sold.
Precautionary Measures
Article 15 – (1) If there is a possibility of harmful effects on human health from any supplementary food imported, produced, processed, and placed on the market, if scientific uncertainties continue, and if existing measures are insufficient, the Ministry may take precautionary measures such as temporarily stopping production or entry into the country, banning market placement and use, preventing consumption, and recalling until more scientific data that allows a comprehensive risk assessment is obtained.
(2) Food operators must comply with the precautionary measures determined by the Ministry.
(3) The Ministry cannot be held liable for any responsibility arising from the implementation of precautionary measures, and no compensation can be claimed from the Ministry.
Official Control
Article 16 – (1) Official control is conducted for food businesses and supplementary foods according to the Law, the Regulation on Official Controls of Food and Feed published in the Official Gazette No. 28145 dated 17/2/2011, and the provisions of this Regulation.
Labeling
Article 17 – (1) Food operators within the scope of this Regulation must comply with the provisions of the Turkish Food Codex Labeling Regulation published in the Official Gazette No. 28157, 3rd Repetition dated 29/12/2011, and the relevant legislation.
CHAPTER FIVE
Miscellaneous and Final Provisions
Administrative Sanction
Article 18 – (1) Administrative sanctions are applied to those who act contrary to the provisions of this Regulation according to the relevant articles of the Law.
Regulations on Implementation
Article 19 – (1) The Ministry prepares instructions or guidelines for the implementation of the provisions of this Regulation if deemed necessary.
Product Tracking System
Article 20 – (1) The Ministry establishes a product tracking system and can implement special applications for the application of the tracking system in supplementary foods if deemed necessary to ensure traceability.
Temporary Provisions
Temporary Article 1 – (1) It is mandatory to obtain approval according to this Regulation for supplementary foods imported and/or produced and/or processed and/or placed on the market before the effective date of this Regulation by 31/12/2014.
Enforcement
Article 21 – (1) This Regulation enters into force three months after its publication date.
Execution
Article 22 – (1) The provisions of this Regulation are executed by the Minister of Food, Agriculture, and Livestock.
Annex-1
INFORMATION AND DOCUMENTS REQUIRED FOR THE PRODUCTION, PROCESSING, AND IMPORT OF SUPPLEMENTARY FOOD TO BE EVALUATED BY THE SUPPLEMENTARY FOOD COMMISSION
- Original label sample containing the name and trademark of each supplementary food to be produced, processed, and imported,
- Production flow chart of each supplementary food,
- Percentage ingredient list of each supplementary food,
- Specification document showing the nature (powder, extract, etc.) and the amount per unit (tablet, capsule, spoon, etc.) of the active ingredients in each supplementary food,
- Analysis report showing the nutritional or physiological effects of the nutrients such as vitamins, minerals, proteins, carbohydrates, fibers, fatty acids, amino acids, or other substances found in the composition of each supplementary food,
- Recommended daily intake dose of each supplementary food.
Annex-2
INFORMATION AND DOCUMENTS REQUIRED FROM FOOD OPERATORS PRODUCING, PROCESSING, AND IMPORTING SUPPLEMENTARY FOOD WITH THE SAME COMPONENTS AND FOOD OPERATOR, WHOSE NAME AND TRADEMARK HAVE CHANGED, AND WHO HAVE BEEN APPROVED FOR PRODUCTION AND IMPORT PREVIOUSLY
- Original label sample containing the name and trademark of each supplementary food to be produced or imported,
- Declaration stating that the percentage ingredient list of the previously approved supplementary food has not changed.
Annex-3
INFORMATION AND DOCUMENTS REQUIRED FOR SUPPLEMENTARY FOODS CONSISTING OF A SINGLE PLANT SPECIFIED AS POSITIVE ON THE PLANT LIST AND CONSISTING OF A SINGLE COMPONENT WITH LIMITS SPECIFIED IN THE RELEVANT LEGISLATION
- Original label sample containing the name and trademark of each supplementary food to be produced, processed, and imported,
- Production flow chart of each supplementary food,
- Percentage ingredient list of each supplementary food,
- Recommended daily intake dose of each supplementary food.
Annex-4
GENERAL UNDERTAKING FOR SCIENTIFIC MEMBER OF THE SUPPLEMENTARY FOOD COMMISSION
Title (Dr., Assist. Prof. Dr., Assoc. Prof. Dr., Prof. Dr., Other):
Name :
Surname :
Duty :
I, …………………………………….., hereby undertake that I will continuously attend meetings unless I have a valid excuse, and I will act independently of any external influence during the meetings.
DATE SIGNATURE
