Take advantage of other countries in America
Food safety in the US: different countries, different standards
The US market is big. Belongs to the world's leading regions in the food industry. And he's fancy. This makes it interesting for many German exporters: beer, baked goods, sweets, but also various ingredients or dietary supplements from Germany are well represented on the shelves of American retailers and those of the processing industry.
Regardless of the market potential and the many success stories, there are also various entrepreneurs who shy away from entering the market. Not just because of the distance and the intensity of the competition. It's the stories about the Food and Drug Administration (FDA), the state agency that is responsible for controlling all foods placed on the US market. Dealing with the American regulations is time-consuming and costly. Hardly profitable for small businesses if you are not absolutely sure of the turnover. Fairy tale or justifiable worry?
Beatrice Moreau, Senior Regulatory Advisor at the international consultancy Registrar Corp, says: “The product and approval standards in the USA are different from those in Europe. That is why entering the market is of course associated with additional work for German manufacturers. But it is not so complex or expensive that it cannot be easily traded by small businesses. Whether it is successful or not is not a question of company size, but a question of commitment. "
Ninety percent of the time, conversations with local entrepreneurs are always about the FDA. In addition to the FDA, there are also two other relevant authorities: US-DA and TTB?
“The FDA regulates most food products, beverages, and supplements. Meat and poultry products, on the other hand, are commonly regulated by the US Department of Agriculture (USDA). Unfortunately, sometimes it's a little more complicated. For example, turkeys, geese, or ducks fall back under the jurisdiction of the FDA. And for manufacturers and exporters of alcoholic beverages, although they register with the FDA, they must have their labels approved by the Alcohol and Tobacco Tax and Trade Bureau (TTB). Additional state specifics may need to be observed. California is known for its own ways. It is no different in the food sector ”.
"Foreign entrepreneurs often speak of" FDA approvals, "adds Beatrice Moreau. “The FDA itself does not approve any food, drink or dietary supplement. What it does, however, is to block products that do not meet US regulations at customs, delete registrations or send warning letters. This happens, for example, if the product labeling or the list of ingredients does not meet US standards. The registration is incorrect. Or the quality documentation shows deficiencies. "
The registration, the FDA agent and the prior notice
By law, all companies that manufacture, process, package, or store food, beverages, or dietary supplements intended for consumption in the United States must register with the U.S. Register with the FDA. But what does that mean in practice for products that are manufactured by different companies? For example, do fruit growers, juice producers, bottlers and also the trader who ultimately exports apple juice to the USA all have to register with the FDA?
"The FDA only expects the registration of the last processing plant. In this case the bottling plant. However, if the product is stored at the dealer, i.e. the exporter, then the latter must also register. This is a rule of thumb. It is difficult to standardize value chains. That is why a confirmation from a competent expert is always worthwhile. Incidentally, the registration must always be up to date - this also applies to any changes in company name or shareholder structure. Every couple of years - at the end of the fourth quarter - renewals of the company registration are also required. "
The FDA requires a US agent to be named upon registration. What is his role and who can it be?
“Agent sounds particularly important for some German companies. The man or woman is important - no question about it. But it's not that difficult to find a suitable agent. The FDA wants a local contact person for all matters that require consultation. Complications at the port, for example. An inspection of the manufacturing facility. Or other regulatory matters. Registrar Corp. fulfills this role for more than 18,000 companies around the world. "
"In addition to registration, foreign food exporters must observe the FDA's prior notice regulations," added Beatrice Moreau. It contains important information about the exporter, the importer, the product and the shipping method. When to submit the advance notice depends on the shipping method (air, sea, land, etc.). Anyone involved in the delivery can submit it - i.e. the US agent, the customs agent or the freight forwarder.
“Labeling errors lead to more than 22 percent of all products withheld at customs. The requirements for daily values, portion sizes or nutritional values are really different than in Europe. And the format and the graphic display also follow different rules, ”explains Beatrice Moreau.
“Manufacturers intending to distribute their finished foods in the United States should regularly follow FDA quality guidelines. The requirements of the Food Safety Modernization Act (FSMA) apply here. Compared to the International Featured Standards (IFS), there are indeed some differences to be considered, for example with regard to the preventive controls, the hazard analysis for ready-to-use products or the qualifications of the people who are allowed to carry out preventive controls at all. But it's not rocket science either.
For many German companies, the different standards that are used for quality assurance in the USA are confusing: HACCP, HARPC, cGMP. Both HACCP and HARPC are food safety standards. While HARPC is mandatory for all food companies, HACCP only applies to certain product categories - meat, poultry, seafood and juice processing companies. The main difference between these standards lies in the definition of hazards. In HACCP these are related to pollutants (reactive approach) and in HARPC to potential risks (preventive approach). The standards control and prevent different levels of security. And cGMP, Current Good Manufacturing Practice, means nothing else than the American variant of the manufacturing standards that apply to food supplements.
FDA is coming! The inspection
“The FDA has the authority to carry out inspections in German production facilities if these products sell in the USA. In business circles one hears again and again that it affects companies with “high-risk products”, for example baby food, fish or seafood or dairy products. Is that true? "
“In principle, every food company registered with the FDA should be aware of the possibility of an inspection. The company receives a corresponding official notification from the FDA - usually two to three months before the planned factory inspection. An inspection can take up to three days, depending on the focus of the inspection and the official findings on site. At best there are no complaints. Should there be any, the company can even react to it during the inspection and have a new verification carried out immediately. When this is not possible or when severe deficiencies against the provisions of the Food, Drug & Cosmetic Act have been identified, Form 483 comes into play. The company then has time to remedy the defects complained about within 15 days and to provide evidence of this accordingly. And even if it doesn't make it, there is still a second stage. A "warning letter" and another 15 days. Only then can there be an import ban. Warning letters are not a nice thing, however. They are published on the FDA website and are therefore practically accessible to everyone. "
Registrar Corp has been a leading provider of FDA compliance advisory services since 2003. The company currently offers support to more than 30,000 companies in 160 countries on all aspects of registration, labeling or legal provisions of the US FDA, and acts as an FDA agent or mediator for problems at customs. As Senior Regulatory Advisor, Beatrice Moreau leads a team that takes care of European manufacturers and exporters who need support with FDA regulations for imports into the USA.
IHK workshop: Fit for FDA! Food safety in the US on April 14th
On April 14th, Beatrice Moreau will give a workshop together with the Chamber of Industry and Commerce Hanover on the US requirements for the successful export and marketing of German products. It is also available for one-on-one discussions. Details on the program / registration can be found online.
The IHK Hannover offers further specialist events for the food industry with the following online workshops on the subject of product labeling under US law:
• Fitter for FDA - US labeling for food
• Fitter for FDA - US labeling for dietary supplements
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