In recent years, hemp-derived CBD has exploded onto the European markets. It is popular in European pharmaceutical, personal care, cosmetic, nutraceutical, and medical markets (and for each of these, there are different requirements). According to Grand View Research, the European hemp-CBD market is poised to grow 400% by 2025. This market is complex, as the EU consists of twenty-eight member states, each with its own languages, laws, and regulations to apply to hemp CBD.
Hemp-CBD considered a “Novel food”
While hemp products such as whole seeds (hemp hearts), seed oil, hemp seed flower, and defatted hemp seed are not considered “novel foods,” hemp-CBD extract, and products containing it are. But what is a “novel food”? The European Commission defines a novel food as any product not eaten “to a significant degree” before May 15, 1997, when the first Regulations began. Every “novel food” must go through a rigorous confirmation process to even enter European markets. So, businesses seeking to sell CBD products or hemp-CBD in Europe must go through this process, dictated by the European Food Safety Authority (EFSA).
The company must show a product to be:
a) Safe for consumers,
b) Properly labeled and not misleading, and
c) not nutritionally disadvantageous when replacing a similar food. The process itself is expensive, costing anywhere from €300,000 to €400,000, and may take three to four years. It has three phases: Assessment, Safety Assessment, and Marketing Authorization.
Different member states have varying laws. Even if one’s product passes the “novel food” test, to be sold in certain countries the product may have to adhere to additional or differing standards. For instance, products must follow a country’s respective labeling requirements. Moreover, the European Industrial Hemp Association (EIHA) recently pushed the German Government and the Federal Ministry of Food and Agriculture to recognize the difference between natural and enriched cannabinoids. Foods “containing parts of the hemp plant” are not considered “novel foods,” which is a milestone, but the fight continues. How this will affect regulations in other countries is unclear. Spain, Italy, and Austria have taken actions against hemp-CBD products because they were “novel foods.”
Exporting CBD Products From the U.S.
Exporting comes with its own set of challenges. Regulations are strict even for intra-European trade, and incongruities in U.S. laws and regulations confound the barriers for exporting.
American business seeking to export hemp-CBD to Europe not only must meet the guidelines of the European Food Safety Authority (EFSA) and be EU Good Manufacturing Practices (GMP) compliant (meaning it also must be organic), but also adhere to U.S. guidelines. This includes regulations from the FDA, DEA, USDA, and Customs.
U.S. exporters will often be asked for a written “export certification” from the FDA. The FDA does not consider hemp-derived CBD as a dietary supplement, so depending on the marketing of the product, they may not issue such certification. Regarding exports for products containing CBD, FDA simply says “follow U.S. laws and regulations,” and punts to DEA, which coordinates with Customs on exports. At the very least this creates a bureaucratic mess for exporters but may also result in a denial from the importing nation.
According to CannaLawBlog, while DEA and Customs should allow hemp-derived CBD products to ship, companies may face issues with Customs due to human error, like misunderstandings of the difference between hemp and marijuana. Moreover, Amin Talati Wasserman — a firm specializing in food law – writes that businesses aiming to import or export hemp “clones, materials and finished products… face risks of enforcement actions,” according to several interviewed attorneys. The article states further that “exporting certain finished hemp products … could be problematic even if the THC falls within the Farm Bill’s definition because FDA has long asserted hemp-derived CBD cannot be added to food or marketed as a dietary supplement.”
Even New York products, despite following stringent production standards such as GMPs, may run into issues with Customs and the DEA in the process of exporting.
Clearly, the European market for hemp-derived products is opening but regulator complexities may keep many businesses from taking advantage of the opportunity. More clear laws and guidance from American regulation agencies, specifically the FDA, is needed to smooth the process of exporting to Europe. The U.S. Department of Commerce should coordinate across agencies to streamline the export process to help U.S. hemp companies access badly needed new markets.
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