Memo Regarding Recent Regulations Concerning the Food & Agriculture Sectors
MEMO REGARDING THE REGULATION ON PHARMACOLOGICALLY ACTIVE SUBSTANCES IN FOODSTUFFS OF ANIMAL ORIGIN AND THE REGULATION ON THE ADDITION OF VITAMINS AND MINERALS AND OF CERTAIN OTHER SUBSTANCES TO FOOD
Two important regulations concerning food business operators within the food, agriculture and livestock sectors entered into force after being published in the Official Gazette dated 7 March 2017 and numbered 30000. Within this scope detailed information regarding the Turkish Food Codex Regulation on the Classification of Pharmacologically Active Substances in Foodstuffs of Animal Origin and Residue Limits and the Turkish Food Codex Regulation on the Addition of Vitamins and Minerals and of Certain Other Substances to Food are set out below.
- The Turkish Food Codex Regulation on the Classification of Pharmacologically Active Substances in Foodstuffs of Animal Origin and Residue Limits
The Regulation was prepared pursuant to the relevant EU Regulations to ensure food safety by classification of pharmacologically active substances in foodstuff of animal origins that can be determined scientifically and technically and to establish their maximum residue limits. Within this scope the previous regulation is being repealed by this regulation[1].
The Scope
The Regulation encompasses classification of pharmacologically active substances relating to veterinary medicinal products in foodstuffs of animal origin and their maximum residue limits. On the other hand, the Regulation shall not apply to biological active materials used in immunological veterinary medicinal products to produce active or passive immunity or to diagnose a state of immunity and diagnostic kits and materials within the scope of the Turkish Food Codex Regulation on Contaminants. Additionally the Regulation shall apply without prejudice to the legislation prohibiting (and subject to certain conditions) the use of hormones or similar materials in food-producing animals.
Pharmacologically Active Substances
Pharmacologically active substances are defined as a substance which is found in a premixed medicine and that may cause a pharmacological effect to an organism. The Regulation regulates the pharmacological active substances that are allowed and prohibited to be used in food-producing animals.
Within the scope defined above, the classification of pharmacologically active substances that are allowed to be in foodstuff of animal origin and their maximum residue limits are set out within Annex-1. Part 1 of the Annex-1 defines the pharmacological active substances that are allowed and their residue limits, Part 2 sets out the substances that are prohibited to be used due to causing danger to human health and substances that are not allowed to be found in foods on any level.
Requirement of Compliance and Administrative Sanctions
Food business operators that are active before the Regulation’s date of effectiveness are required to ensure compliance with the provisions of this Regulation until 1/6/2017 and until this date the provisions of the repealed Regulation shall be implemented.
In case of breach of this Regulation, administrative sanctions shall be applied as per the provisions of the Law on Veterinary Services Plant Health Food and Feed numbered 5996.
- The Turkish Food Codex Regulation on the Addition of Vitamins and Minerals and of Certain Other Substances to Food
The Regulation was prepared for protection of consumers by regulating the procedures and principles of addition of vitamins, minerals and certain substances to food in line with the relevant EU Directives.
The Scope
The Regulation encompasses the vitamins, minerals and certain substances that may be added to food. This Regulation shall not be applied with regard to vitamin and minerals in terms of foods within the scope of the Turkish Food Codex Communique on Food Supplements[2]. For the following matters the Regulation shall be applied without prejudice to the specific provisions in the relevant legislation:
- Foods for particular nutritional uses and, in the absence of specific provisions, compositional requirements of such products rendered necessary by the particular nutritional requirements of the persons for whom they are intended,
- Additives within the scope of the Turkish Food Codex Regulation on Food Additives and flavorings within the Turkish Food Codex Regulation on Flavourings and Certain Food Ingredients with Flavouring Properties which was published in the Official Gazette of 29/12/2011 and numbered 28157,
- Authorized oenological practices and processes.
Addition of Vitamins and Minerals to Foods
Only vitamins and/or minerals listed in Annex I, in the forms listed in Annex II, may be added to foods, subject to the rules laid down in this Regulation. Within this scope, vitamins and minerals in a form that is bio-available to the human body may be added to foods, whether or not they are naturally contained therein by taking into account at least one of the matters set out below:
- a deficiency of one or more vitamins and/or minerals in the population or specific population groups that can be demonstrated by clinical or sub-clinical evidence of deficiency or indicated by estimated low levels of intake of nutrients; or
- the potential to improve the nutritional status of the population or specific population groups and/or correct possible deficiencies in dietary intakes of vitamins or minerals due to changes in dietary habits; or
- evolving generally acceptable scientific knowledge on the role of vitamins and minerals in nutrition and consequent effects on health.
Restrictions on the addition of vitamin and minerals
Without prejudice to the provisions of specific legislation, vitamin and minerals may not be added to unprocessed foodstuffs, including, but not limited to, fruit, vegetables, meat, poultry and fish; beverages containing more than 1,2 % by volume of alcohol, provided that no nutrition or health claim is made.
Conditions for the addition of vitamin and minerals
When a vitamin or a mineral is added to foods, the total amount of the vitamin or mineral present, for whatever purpose, in the food as sold shall not exceed maximum amounts. For concentrated and dehydrated products, the maximum amounts set shall be those present in the foods when prepared for consumption according to the manufacturer’s instructions.
The maximum amounts shall be set taking into account the following terms:
- upper safe levels of vitamins and minerals established by scientific risk assessment based on generally acceptable scientific data, taking into account, as appropriate, the varying degrees of sensitivity of different groups of consumers;
- intakes of vitamins and minerals from other dietary sources.
When the maximum amounts are set, due account shall also be taken of reference intakes of vitamins and minerals for the population.
The addition of a vitamin or a mineral to a food shall result in the presence of that vitamin or mineral in the food in at least a significant amount where this is defined under the Turkish Food Codex Regulation on Labelling for Foodstuffs and Informing Consumers. The conditions for minimum amounts, including any lower amounts, by derogation from the significant amounts mentioned above, for specific foods or categories of foods shall be determined by the Ministry of Food, Agriculture, and Livestock (“the Ministry”).
Labelling, Presentation and Advertising
The labelling, presentation and advertising of foods to which vitamins and minerals have been added shall not include any mention stating or implying that a balanced and varied diet cannot provide appropriate quantities of nutrients. Additionally, the labelling, presentation and advertising of foods to which vitamins and minerals have been added shall not mislead or deceive the consumer as to the nutritional merit of a food that may result from the addition of these nutrients.
The nutrition labelling of products to which vitamins and minerals have been added and which are covered by this Regulation are compulsory. The information to be provided by labelling shall consist of the energy value, the amount of nutritional elements and the total amounts present of the vitamins and minerals when added to the food as per the relevant provision of the Turkish Food Codex Regulation on Labelling for Foodstuffs and Informing Consumers.
Addition of Certain Other Substances
The Regulation sets out the conditions for addition of a substance other than vitamins or minerals, or an ingredient containing a substance other than vitamins or minerals, to foods or using these in the manufacturing of foods. Accordingly, the procedure under the third section of the Regulation shall be followed where the ingestion of amounts of this substance or an ingredient containing this substance results as greatly exceeding those reasonably expected to be ingested under normal conditions of consumption of a balanced and varied diet and/or would otherwise represent a potential risk to consumers.
The Ministry shall prepare a List including the substances whose use in foods is prohibited, restricted or under scrutiny. In case of necessity, the General Directorate of Food and Control may include a certain other substance or an ingredient containing a substance to the List. Opinion of the Scientific Commission may be requested during this assessment if necessary.
As a result of the assessment, if a harmful effect on health has been identified, the substance and/or the ingredient containing the substance;
1) be placed in prohibited substances part of the List and its addition to foods or its use in the manufacture of foods shall be prohibited; or
2) be placed in restricted substances part of the List and its addition to foods or its use in the manufacture of foods shall only be allowed under the conditions specified therein.
If the possibility of harmful effects on health is identified but scientific uncertainty persists, the substance shall be placed in substances under scrutiny part of the List.
The General Directorate shall consider the level of supply to the market regarding the foodstuff which the other substance was added into whilst assessing the other substances that are added to foodstuff or used in manufacturing of food. If the assessment reveals that at least one of the conditions below are satisfied, an assessment procedure for inclusion of this substance to the List may be initiated:
- the ingestion of amounts of this substance or an ingredient containing this substance results as greatly exceeding those reasonably expected to be ingested under normal conditions of consumption of a balanced and varied diet and therefore represented a potential risk to consumers due to the adding of this other substance to foodstuff or using it in manufacturing of food,
- a potential risk to consumers is caused due to ingestion of this certain other substance by general adult population or a population with potential risk.
In terms of purposes of the Regulation the conditions resulting as greatly exceeding those reasonably expected to be ingested under normal conditions of consumption of a balanced and varied diet must occur actually.
In addition to the ones under this Regulation, prohibitions and restrictions may be introduced for certain other substances within their own specific legislation.
Requirement of Compliance and Administrative Sanctions
Food business operators that are operating before the Regulation’s date of effectiveness are required to ensure compliance with the provisions of this Regulation until 31/12/2019 and until this date the provisions of the Turkish Food Codex Regulation on Labelling and Turkish Food Codex Regulation on Labelling for Foodstuffs and Informing Consumers shall be complied with.
In case of breach of this Regulation, administrative sanctions shall be applied as per the provisions of the Law on Veterinary Services Plant Health Food and Feed numbered 5996.
For further information regarding these regulations or legislation concerning the food, agriculture and livestostock sectors you may contact us from info@engblaw.com
[1] The Regulation on the Turkish Food Codex Classification of Pharmacologically Active Substances in Foodstuffs of Animal Origin and Residue Limits published in the official gazette of 4/5/2012, numbered 28282.
[2] Published in the Official Gazette of 16/8/2013, numbered 28737.