At the beginning of the meeting, Ms. Mohseni, the head of the Department of Monitoring and Evaluation of Food and Beverage Additives, explained the reasons and the process of amending the guidelines of the Food and Drug Organization. Then, his colleague, Ms. Bagheri, read the mentioned instruction clause by clause, and the attendees expressed their opinion about each clause. Ms. Dr. Kazemi, the head of the Food and Drug Laboratory Research Center, had specialized, scientific, technical, and writing ambiguities and flaws regarding the text, which they explained in detail. Mr. Engineer Khalili, while honoring the accuracy of Dr. Kazemi’s opinion, said that the guidelines should be formulated in such a way that they cannot be interpreted in different ways. But aside from the technical issues, we are confused about the number of construction permits issued, so it is better to deal with the essence of the matter.
The procedure for issuing building permits has undergone new changes.
Mr. Dr. Sadeghian, consultant for technical and policy affairs of the Food Department, said that the process of issuing manufacturing permits has undergone new changes that facilitate the process and can be issued electronically. In the new system, the mother’s license is issued by the organization and the issuing of the daughter’s license is delegated to the units. The view of the Food and Drug Organization is minimal intervention and seeks the maximum participation of the private sector, which will lead to facilitation in the business field. It is attractive for the Food and Drug Administration to require minimum services. Issuing a construction permit is a legal requirement that the organization must fulfill. In order to minimize the issuance of the manufacturing license, there are two restrictions, firstly, the product does not undergo safety and health problems by changing the formulation, and secondly, there is the possibility of tracking the product recall.
In the following, I said that first of all, we are grateful for the positive approach of the Food and Drug Organization in order to facilitate affairs and improve the business environment. In the past, we have had the support of the Food and Drug Organization in many cases, and Mr. Dr. Sadeghian and his colleagues have supported the positions of the industry in various meetings with an expert and logical point of view, which is commendable. The accuracy of Ms. Kazemi’s opinion is also praiseworthy, as she examines the cases in a meticulous and sharp manner. But in my opinion, in this meeting, apart from discussing technical, scientific and specialized topics, which are very important in their own place, it is better to focus more on the main topic, i.e. the process of reforming and facilitating matters related to the issuance of construction permits.
Forming a joint working group
For technical and specialized issues, a working group composed of respected experts from the Food and Drug Organization and experts from the private sector and associations should be formed and the scientific and specialized issues should be addressed carefully and in an expert atmosphere. In this meeting, it is better to focus on how to facilitate the issuance of construction permits. Because the industry has a fundamental problem with the multiple issuance of construction permits. One of the issues that has caused disruption in the production process in the real sense is the multiplicity of construction permits, which has been a common trend for a long time, but unfortunately, over time, the scope and extent of its influence and complexity have increased. In some cases, to facilitate the affairs, it is decided to hand over a part of the issuing process to the private sector. According to the current procedure, manufacturers are required to obtain a new manufacturing license with a slight change in formulation. We are uncertain about the legality of this procedure, and we think that according to the Food and Beverage Law, guidelines can be formulated so that manufacturers do not have to obtain multiple manufacturing permits. Ms. Mohseni said that in the previous instruction, a manufacturing license should have been issued for each flavoring. But in the new instructions, we have classified the flavorings in several groups so that the production flights can be issued based on this grouping. The criterion of action for us was the origin of the flavoring, the shape of the flavoring and the distinguishing feature of the flavoring. The origin of flavor is divided into three categories: natural, artificial and pseudo-natural. The form of flavoring is also diverse, including powder, liquid, emulsion, pill, gel, etc. About the difference between flavorings, things like taste and non-flavor components, fruit and spice flavorings and other things are discussed. In the construction permit issuing system, a series of mother licenses and a series of daughter licenses are defined. We divided the flavorings into 14 general groups regardless of their origin, and mother butterflies will be included in these 14 groups, and daughter butterflies are under these 14 groups.
In Article 8 of the Food and Beverage Law, a manufacturing license must be issued for each product
Mr. Dr. Jahangiri, Secretary of the Additives Association, stated that in Article 8 of the Food and Beverage Law, a manufacturing license must be issued for each product. According to the existing definitions, the product also includes the raw material of the factories. For flavorings, the Food and Drug Organization must define the permitted ingredients, but the change in the ratio of ingredients must be the responsibility of the manufacturer in order to create freshness, intensity and lack of taste, this is prevented by the existing procedure. The producer’s hand should be open in changing the formulation in order to have variety. Mr. Dr. Karimian, one of the Food and Drug Organization’s additives experts, criticized Mr. Jahangiri’s opinions by providing technical and specialized explanations that are beyond the scope of this report.
Mr. Engineer Khalili said that it might be better to declare illegal substances instead of permitted substances in order to provide more and better supervision, which Mrs. Dr. Kazemi welcomed this proposal. Mr. Dr. Sadeghian said that according to the law, the Food and Drug Organization issues three licenses for establishment, operation and construction. The establishment license is for the location, the exploitation license is for the product, which can produce a product with each production line. The manufacturing license is responsible for the details of the formulation. These issues are our red line and no authority can say that the license should not be issued. We can only facilitate the issuance process.
Mr. Engineer Khalili said that the health and safety of products is our red line. We need to get a manufacturing license to produce pure sunflower oil, and we need to get a separate manufacturing license to produce sunflower oil with tocopherol. We have to get 70 manufacturing permits for 4 types of products, which is a problem for the manufacturer. Now issuing a construction permit is like entering a university. The process to enter the university is very difficult, but after entering, everything is free. We are very strict to get the construction permit, but is there enough supervision after that?! Our request is to reverse this process so that construction permits are issued based on self-declaration and then strictness is applied in the monitoring phase.
The concerns of the colleagues of the Food and Drug Organization in the field of health are understandable
I went on to say that the concerns of the colleagues of the Food and Drug Organization in the field of health are understandable and we also believe in them, but with the procedure governing the issuance of construction permits, these concerns are not answered; It means that we will not reach the goal of product health and safety with the number of manufacturing licenses. In order to achieve this, we need to replace the retrospective supervision with the previous supervision. One of the areas of prior supervision is the issuance of permits, which we must reduce the issuance of permits to the minimum possible. In this way, we will help to facilitate the affairs and improve the business environment. In paragraph 5-3-2 of the aforementioned instructions, the term “product name” is mentioned for each manufacturing license.
Article 8 and 9
In Article 8 of the Food and Beverage Law, it is mentioned to issue a manufacturing license for each “product type”, not for each “product name”. In the note under Article 9 of the law, the executive regulations related to Article 8 are mentioned. 12 “types of products” are mentioned in the said regulation. Therefore, a manufacturing license should be issued for each “product type” and not for each “product name”. If the approach of the Food and Drug Organization is to facilitate production, the guidelines should be formulated in such a way as to minimize the number of manufacturing licenses by referring to this legal article and its executive regulations. Mr. Dr. Sadeghian said that things can be facilitated in a step-by-step process.
The organization’s approach to facilitate affairs
The fact that the issuance of girl’s licenses has been entrusted to the technical officer of the unit shows the approach of the organization to facilitate matters. Maximum demands cannot be reached in a short period of time. It is better that the request and demand be in accordance with the conditions and requirements of the country. Mr. Engineer Khalili said that the common concern of the government and the private sector is the health of the product and the people. I suggest that before entering into the issuance of the manufacturing license related to flavorings, a meeting should be held on small points such as “product name” and “product type” and to reach common definitions. Mr. Dr. Jahangiri said that according to the survey we conducted in the countries of China, UAE, Turkey, England and America, only one license is issued for each group of products. I continued that by referring to the existing law and taking into account the health of the product, an intermediate solution can be found to facilitate the production process.
In paragraph 3 of Article 1 of the Food and Beverage Law, it is mentioned “non-compliance with the standard or registered formula”. The conjunction “or” here has a significant legal burden that must be taken into account. According to this clause, the manufacturer must either comply with the relevant standard or comply with the registered formula. The legislator did not use the conjunction “and” here. The legislator did not use the conjunction “and” here. In other words, complying with the relevant standard means complying with the formulation.
Based on this argument, a manufacturing license can be issued for the standard canned tuna in oil number 2870, in which case, with this same manufacturing license, it is possible to produce canned fish with red pepper, dill, etc. Also, based on standard number 37, it is possible to produce all kinds of biscuits with the flavors of coconut, sesame and aromatic vegetables with one propeller. Currently, a manufacturing license is issued for each “product name”, which takes a lot of time and energy from the experts of the Food and Drug Organization. With a positive approach, it is possible to reduce the responsibility of the Food and Drug Organization and facilitate the production of seeds and butterflies. In the end, it was decided that within the next ten days, a correspondence will be sent from the Food Industry Commission of Iran Chamber of Commerce to the Food and Drug Organization in this regard.