Approval of CBD products in Europe

by Team Inc.

2020-05-15-Approval of CBD products in Europe

European regulators are ready to work together on the quality and safety of CBD foods and supplements in the hemp industry. The European Food Safety Authority (EFSA) has told Hemp Industry Daily that it will review applications to raise the bar for approving the sale of over-the-counter CBD products.

Working together on high-quality CBD

Collaboration can be very useful to improve the quality of products. When we know what the products contain, in what form, degree and quality, the number of animal tests can be limited, for example. “It would make sense to collectively collect toxicological (or even human) data when it comes to creating a highly purified, well-defined substance,” the EFSA spokesperson said in an email.

European hemp groups' collaborative efforts are taking off as many CBD manufacturers struggle to include cannabinoids under the EU Novel Food Catalog. CBD's new food designation, announced in January 2019, means that many over-the-counter cannabidiol products must first receive regulatory approval before they can be marketed.

Enforcement and approval

Enforcement of novel food law is left to EU member states, leading to a patchwork of CBD availability across the continent. EFSA is the EU agency that carries out risk assessments for novel food uses. The process for applying for EU approval is a lengthy and costly one, said Adela Williams, lawyer and partner of the life sciences group at Arnold & Porter law firm in London.

"That includes a whole series of studies, both preclinical and in humans, on the novel food product, on its absorption, distribution, metabolism, excretion and toxicity," said Williams. The necessary data will be linked to the expected daily intake and the type of people expected to consume or eat the product, Williams said. For example, if a target population of a novel food includes pregnant women, the application should include a survey of that vulnerable population.

Data protection and requests

“It takes a whole range of data, and the extent to which a company should invest in data depends on what's already been published,” Williams said. Smaller and medium-sized businesses may be more likely to consider a group filing for a new food authorization, Williams said. “The larger companies will likely want to create a stand-alone application,” Williams said. "They will have the resources to develop their own data and want to get a period of data protection." The European Commission can offer data protection applicants for novel foods protection for up to five years. As a result, the application and the data contained therein remain in the hands of the applicant.

One authorization for multiple products

Williams pointed out that current novel food regulations allow for generic authorization. “That means you can have a new food application that is not specific to the product of one company. It can be applied to anyone who makes a product that has the same conditions of use, the same labeling and the same specifications. ”

EFSA allows for new food applications with two or three different formulations made by one producer, as long as those formulations are made in one production process. In such cases, the Agency will include the following considerations in the evaluation for approval:

  • Production steps
  • Impurities
  • Terms of Use
  • Maximum dose levels
  • Foodstuffs to which an ingredient can be added

But the committee does not accept different formulations from different manufacturers for the same application, the EFSA spokesperson said.

Read more hempindustrydaily.com (Source, EN)

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1 comment

Constantine Benegui October 15, 2020 - 14:52

Liniștitoare, calmare, vindecatoare, bună din toate punctele de verde

Answered

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