The US Food and Drugs Administration (FDA) will officially apply the new FDA Food Safety Modernisation Act (FSMA) from now to early 2016. A Viet Nam News Agency reporter talked with On Le Thi Bich, head of the export-import department of the Vina Commodities Co, about how the new rules will affect local firms.
As an experienced exporter to the US, could you tell me about the most important parts of the new FSMA and what businesses exporting products to this market should look out for?
Labels recorded with unadequate information are one of the main causes for products on their way into the US market being held up at the port. The new provisions in the FSMA require more specific details, especially in the labelling method. In addition, some general requirements must be met, such as product name, weight, ingredients, and the new law also has different rules for various types of products.
In particular, labelling must be in more than one language, with English being compulsory. Enterprises are also required to ensure these translations are precise. In addition to requests of the importers and general standards of the US market, enterprises will also be required to ensure the standard of their goods are checked by third parties.
The FSMA will speed up checks on the production facilities of export countries and the facilities must meet certain standards set by the FDA. Export companies may also have to pay costs for any inspections.
Food exporters to the US are also required by the FDA to list the health risks associated with their products. These documents must be available during any inspections carried out by the FDA.
Small businesses may be exempt or enjoy less strict implementation of these requirements. A small firm is defined as an enterprises with revenue of less than $500,000 per year.
To ensure that Vietnamese food, drugs and beverages are eligible to be imported into the US, the importers are required to set up programmes to confirm the safety of all shipments into the US with safety certificates for each shipment.
Starting from this year, each facility must be registered with the FDA once every two years. Re-registration has to be made in the fourth quarter every even-numbered year.
Export facilities are required to appoint a representative located in the US who the FDA can contact, under requirements in the Anti-Terrorism Act issued in 2002.
The act also allows the FDA to have the authority to order, not merely require companies to recall contaminated food.
What are the disadvantages of the new rules for exporters?
Before the act came into force, it was more convenient for us to export goods to the US. Previously, we had to register with the FDA one time only rather than periodically register every two years under the new rule. Firms often forget to do this.
Another advantage was that goods entering into ports only required adequate documents and inspection by customs officers for clearance. But now, enterprises will face additional difficulties if there are any problems related to food hygiene and safety, as all these goods will be held until the procedures are completed. It will take more time, thus there will be an impact on any type of perishable goods.
Previously, besides the requirements of the importers and the general standards of the US market, standards on goods safety certified by a third party were acceptable, but now the FDA does not recognise the results of these certification units.
Under the previous regulations, a HACCP (Hazard Analysis and Critical Control Point) was not required by the FDA, but under the new rule, commodities entering the US have to meet HACCP standards.
The US has adopted this standard on seafood and beverages. By early 2013, the US will put an additional regulation on good manufacturing practice (CGMP).
Does your company have any measures to ensure compliance with the new law?
Before exporting to the US, we must thoroughly understand the export procedures and requirements to avoid any risks. We must also modernise our facilities with advanced equipment and technologies to satisfy the requirements of customers as well as food safety standards.
We export many agricultural products, including cashew nuts, and these are exported to 25 countries around the world, including the US. We send over 100 tonnes of the goods each year to this market. However, when the law takes effect, the greatest difficulty is that we have to re-register with the FDA as each time a registration is made it takes time for them to re-evaluate and make sure that our factory satisfies food hygiene and safety standards before we are allowed to ship goods to the market. — VNS
As an experienced exporter to the US, could you tell me about the most important parts of the new FSMA and what businesses exporting products to this market should look out for?
Labels recorded with unadequate information are one of the main causes for products on their way into the US market being held up at the port. The new provisions in the FSMA require more specific details, especially in the labelling method. In addition, some general requirements must be met, such as product name, weight, ingredients, and the new law also has different rules for various types of products.
In particular, labelling must be in more than one language, with English being compulsory. Enterprises are also required to ensure these translations are precise. In addition to requests of the importers and general standards of the US market, enterprises will also be required to ensure the standard of their goods are checked by third parties.
The FSMA will speed up checks on the production facilities of export countries and the facilities must meet certain standards set by the FDA. Export companies may also have to pay costs for any inspections.
Food exporters to the US are also required by the FDA to list the health risks associated with their products. These documents must be available during any inspections carried out by the FDA.
Small businesses may be exempt or enjoy less strict implementation of these requirements. A small firm is defined as an enterprises with revenue of less than $500,000 per year.
To ensure that Vietnamese food, drugs and beverages are eligible to be imported into the US, the importers are required to set up programmes to confirm the safety of all shipments into the US with safety certificates for each shipment.
Starting from this year, each facility must be registered with the FDA once every two years. Re-registration has to be made in the fourth quarter every even-numbered year.
Export facilities are required to appoint a representative located in the US who the FDA can contact, under requirements in the Anti-Terrorism Act issued in 2002.
The act also allows the FDA to have the authority to order, not merely require companies to recall contaminated food.
What are the disadvantages of the new rules for exporters?
Before the act came into force, it was more convenient for us to export goods to the US. Previously, we had to register with the FDA one time only rather than periodically register every two years under the new rule. Firms often forget to do this.
Another advantage was that goods entering into ports only required adequate documents and inspection by customs officers for clearance. But now, enterprises will face additional difficulties if there are any problems related to food hygiene and safety, as all these goods will be held until the procedures are completed. It will take more time, thus there will be an impact on any type of perishable goods.
Previously, besides the requirements of the importers and the general standards of the US market, standards on goods safety certified by a third party were acceptable, but now the FDA does not recognise the results of these certification units.
Under the previous regulations, a HACCP (Hazard Analysis and Critical Control Point) was not required by the FDA, but under the new rule, commodities entering the US have to meet HACCP standards.
The US has adopted this standard on seafood and beverages. By early 2013, the US will put an additional regulation on good manufacturing practice (CGMP).
Does your company have any measures to ensure compliance with the new law?
Before exporting to the US, we must thoroughly understand the export procedures and requirements to avoid any risks. We must also modernise our facilities with advanced equipment and technologies to satisfy the requirements of customers as well as food safety standards.
We export many agricultural products, including cashew nuts, and these are exported to 25 countries around the world, including the US. We send over 100 tonnes of the goods each year to this market. However, when the law takes effect, the greatest difficulty is that we have to re-register with the FDA as each time a registration is made it takes time for them to re-evaluate and make sure that our factory satisfies food hygiene and safety standards before we are allowed to ship goods to the market. — VNS
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