The Thai government is promoting a ‘Thailand 4.0’ policy as a new initiative and economic model aimed at pulling Thailand out of the middle-income trap and pushing the country towards the high-income range. The Thailand 4.0 development plan focuses on 10 targeted industries and food innovation is one of these. Thailand’s transformation and development is a major priority for the government as elections are likely next year. As such, it is very important to increase service efficiency to align with the Thailand 4.0 plan, a goal of which is to streamline access to various government sectors for the public and entrepreneurs.
The Food and Drug Administration (FDA), responsible for protecting and promoting public health, has introduced an electronic platform designed to increase efficiency by establishing an E-Submission system to expedite public access to government services under Sections 14 and 15 of the Licensing Facilitation Act B.E. 2558 (2015). For several years now, cosmetic products have been registrable under FDA’s E-Submission platform. Now, food product applications have been included as well. This E-Submission system has the potential to make obtaining official licences and approvals much easier. Moreover, the official procedures manual must contain all the rules, conditions, and procedures associated with submitting a licence application. Officials are not allowed to deviate from what the manual stipulates. In other words, an official does not have any discretionary subjective authority as to what should or should not be submitted when applying for a license. The official manual governs the application process, not the official.
E-Submission is a new facilitation system for participating companies. The application filing process has changed so that entrepreneurs can file their applications online instead of having to reserve a place in a queue through the system and then manually filing the application at the FDA.
The E-Submission system is divided into two parts: Auto E-Submission and E-Submission. Auto E-Submission allows FDA to provide public facilitation services for entrepreneurs to file their applications online. The system will then consider and certify that filed application automatically (if all information is complete) without FDA officer consideration. Auto E-Submission is the primary verification system for some types of foods, which we will mention below. E-Submission is a slightly different system where FDA also provides public facilitation for entrepreneurs to file their applications online, but the main difference from Auto E-Submission is that E-Submission will not automatically consider and certify an application and an official will have to review the application before giving a decision on the license.
Auto E-Submission System
Most food products are now under the Auto E-Submission system, which means applications are considered and certified automatically. FDA classifies food products under the Auto E-Submission system into two groups, depending on the risk level of the food, as follows:
Standardised Food: This group comprises foods with a medium-risk level. There are quality and labeling standards for each category of food. However, product owners are directly responsible for ensuring their products are in accordance with FDA regulations. The foods in this group eligible for Auto E-Submission are 100 percent coffee, edible salt, vitamin-fortified rice, alkaline-preserved egg, cream, chocolate, tea, herbal tea, some kinds of sauces (i.e. tomato sauce, chili sauce, papaya sauce, and flour sauce), ice, soy milk, drinking water, fish sauce, honey, peanut oil, butter oil, palm oil, coconut oil, fats and oils, mineral water, vinegar, butter, cheese, ghee, margarine and fat spreads, soy sauce, jam, jelly and marmalade, semi-processed food, brine for cooking, and pre-packaged food.
Food with Labelling: This group comprises foods with a medium-risk level. The FDA was formerly responsible for approving the labelling of food in this group. Currently, the guidelines for this group are no different than for Standardised Food. Product owners are directly responsible for ensuring their products are in accordance with FDA regulations. Foods in this group eligible for Auto E-Submission are bread, husked-rice flour, sauces, meat products, flavoring, gelatin and jelly desserts, chewing gum and candy, ready-to-cook and ready-to-eat products.
After FDA studied and evaluated the effectiveness of the Auto E-Submission system, they decided that Auto E-Submission cannot completely analyse and make decisions as efficiently as a trained officer. During their oversight investigation, they found several errors regarding approvals in the Auto E-Submission system. Therefore, Auto E-Submission has caused the completely automatic FDA registration system to be somewhat unreliable, which has led to the cancellation of Auto E-Submission, effective sometime in August 2017. FDA will reorganise all foods under this group for processing through the E-Submission system.
On August 10, 2016, FDA opened the E-Submission system to provide on-line food licence registration services. The existing foods eligible for processing through the E-Submission system are food supplements and royal jelly and its products. The FDA has implemented a new policy to enter all food licence registration into the E-Submission system, including registrations for food manufacturing licences, food import licences, food advertising licences and certificate approval. Several new categories of foods will be added into the E-Submission system in August 2017:
Specially-Controlled Food: This category contains those foods at a high-risk level and is tightly controlled. It includes foods for consumer groups at risk, such as infants. The foods in this group are modified infant milk and modified infant milk formula, infant food and infant food formula, supplementary food for infants and young children, weight-control food, specially purpose food and food additives.
Certain Standardised Food: This category contains beverages, cow’s milk, flavored milk, milk products, yoghurt, ice cream, food in hermetically-sealed containers, mixed coffee and electrolyte drinks.
Food Manufacturing Licence
Food Import Licence
Food Advertising Licence
Certificate Approval: This certificate contains Certificate of Manufacturer, Certificate of Free Sale and Certificate of Ingredient.
FDA will also ensure further flexibility in the E-Submission system by giving an applicant the opportunity to revise errors in an application or dossier after submission. Previously, FDA would not allow any revisions, which had the effect of outright rejecting an entrepreneur’s flawed application.
There is an additional cost applicants must now bear when filing an application in the new E-Submission system. Mandatory fees must be paid for an officer to review an application. Previously, FDA provided free advice and free license approval for most food products and charged licence fees for food manufacturing licenses, food import licences and food product licences of specially-controlled food only. This is the one of reasons for the high number of applications and why FDA approval process has been relatively slow. Many entrepreneurs applied for food licences (as they were free-of-charge) without any plans to launch actual products. This new fee payment policy for an FDA officer to review an application will help to reduce the volume of unnecessary applications and will also assist FDA approval process to proceed at a faster rate.
Siradapat Ratanakorn is a food technologist and consultant in Tilleke & Gibbins' regulatory affairs group. She handles all matters pertaining to food, including Thai Food and Drug Administration (FDA) registration and strategy. Prior to joining Tilleke & Gibbins, she worked for the Thai FDA, where her primary responsibilities involved import licences, food registration, and classification, particularly in relation to food supplements, beverages, and food additives.