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©2019 by Green Swell

英國為CBD食品銷售排除了法規上所面臨的困難,但增加了劑量限制和安全期限。

Updated: Feb 17

UK clears path for CBD food sales but adds dosage limits and safety deadline.



英國食品監管機構已經為CBD行業提供了一年多的時間以申請安全性評估,以保持貨架期,這是一個里程碑式的進展,因為許多國家尚未決定是否可以在食品中銷售大麻二酚。

該指南發布之際,包括澳大利亞,加拿大和美國在內的許多其他國家都表示,他們正在審查食品和營養補品中的CBD安全性,但尚未批准其銷售或說應如何生產,從而引發了全球混亂的混亂。關於大麻二酚的合法性。 英國新的食品法規規定,2021年3月31日之後,只有“提交有效申請的產品才能被允許在市場上銷售”。在此之前,只要產品符合以下條件,CBD產品就可以保留在貨架上:

-正確標記

-安全食用

-請勿包含毒品法規中規定的物質 該機構首席執行官艾米麗·邁爾斯(Emily Miles)在一份聲明中說,該方向是“在保護公共衛生與消費者選擇之間取得平衡的務實而適度的步驟”。該政策公告表明,最近與歐盟斷開關係的英國計劃遵循歐盟委員會實施的食品法規。該機構去年表示,CBD提取物未經售前安全授權就不能作為食品成分銷售,因為它是一種新穎食品,或者是1997年以前不常食用的食品。

新穎的食品名稱對歐盟國家具有影響力,但不具有法律約束力,導致整個歐洲的CBD執法混亂。如今,儘管CBD食品尚未在英國獲得廣泛認可,但尚未獲得此類批准。

根據總部位於倫敦的大麻藥中心的史蒂夫·摩爾(Steve Moore)的說法,想要向英國出售的CBD生產商將在2020年底之前將批准計劃發送給歐洲當局。此後,申請將移交給英國當局。

贏家和輸家

英國更新的《生物多樣性公約》指南使製造商和零售商明確瞭解如何合法銷售生物多樣性公約食品。總部位於倫敦的大麻業務諮詢公司Hanway Associates的高級顧問羅伯特·庫克森(Robert Cookson)預測,法律的明確性將改變英國的市場。 庫克森告訴《 大麻工業日報 》:“力量將轉向參與獲得新型食品批准的CBD供應商。”“他們可能會為其產品收取高價,甚至有可能在部分供應中出現產品短缺。”

儘管截止日期僅要求提交申請但未批准,但該政策將縮小英國CBD產品的行列。

漢威首席執行官喬治·麥克布賴德(George McBride)說 “獲得應用程序是一回事; 獲得批准是另一回事。” “生成所需的技術信息可能要花費數百萬英鎊。” “ 在英國運營的數百家CBD公司中,只有極少數公司有能力做到這一點。 我們希望這一FSA公告能夠推動合併。” 英國大麻產業協會(ACI)幾個月前承諾其成員尋求為其CBD產品尋求新穎的食品授權。該行業組織對FSA的決定表示歡迎。ACI監管負責人Parveen Bhatarah在一份聲明中說:“至關重要的是,該行業現在必須採取一切必要的投資措施,以確保我們能夠完全遵守法規。”

務實執法

McBride將FSA的舉動視為“英國大麻改革之路中一系列具有里程碑意義的里程碑中的第一件事 ” 他對《 大麻工業日報》表示:“英國大麻和CBD商業未來可能發生的藍天事件可能是許可制度的變化,允許農民從大麻中提取CBD。” FSA監管英格蘭,威爾士和北愛爾蘭的食品安全,這意味著該措施不適用於蘇格蘭,蘇格蘭食品標準是負責機構。它也不適用於化妝品、 電子菸和提出醫藥要求的產品。 含有四氫大麻酚或其他管製藥物的產品。FSA還建議孕婦和哺乳婦女“不要食用CBD產品”,並建議健康的成年人在服用任何CBD之前“請慎重考慮”,建議每日劑量不要超過70毫克,即28滴5%的CBD油。

FSA對消費者的警告基於英國毒性委員會的報告結果,該委員會由科學家組成,該委員會準備了CBD審查,以供FSA證明其最近的決定。毒性委員會的報告基於美國和歐洲衛生監管機構批准的CBD藥物的研究數據,該藥物用於治療罕見類型的癲癇病Epidiolex。該委員會使用了該藥物的科學臨床和非臨床數據,這些數據先前已由衛生當局(包括美國食品和藥物管理局)用於批准該藥物。由於該數據是供藥品使用,而不是非處方使用,因此委員會的報告指出“在不適用於食品風險和收益之間進行權衡”。毒性委員會主席艾倫·布比斯(Alan Boobis)在報告中警告說,“食用這些產品可能會對健康產生不利影響。”

British food regulators have given the CBD industry a little over a year to apply for safety evaluations in order to remain on shelves, a landmark advancement as many nations have yet to decide whether cannabidiol can be sold in food.

The guidelines came as many other nations – including Australia, Canada and the United States – have said they’re reviewing CBD safety in food and nutritional supplements but not yet endorsed its sale or said how it should be produced, prompting a global morass of confusion about cannabidiol’s legality.

The new U.K. food rule stipulates that after March 31, 2021, only products that have “submitted a valid application will be allowed to remain on the market.”

Until then, CBD products can stay on store shelves, as long as the products are:

Correctly labeled.Safe to eat.Do not contain substances that fall under drugs legislation.

The direction is a “pragmatic and proportionate step in balancing the protection of public health with consumer choice,” Agency Chief Executive Emily Miles said in a statement.

The policy announcement indicates that the U.K., which recently broke ties with the European Union, plans to follow food regulations implemented by the European Commission.

That agency said last year that CBD extract can’t be sold as a food ingredient without premarket safety authorization because it is a novel food – or something not commonly eaten before 1997.

The novel food designation, which is influential but not legally binding on EU nations, has led to a confusing mix of CBD enforcement across the continent.

Today, no CBD food product has obtained such an approval, though the products are widely available in the United Kingdom.

According to Steve Moore of the London-based Centre For Medicinal Cannabis, CBD producers who want to sell into the U.K. will send approval plans to European authorities through the end of 2020. After that, applications will be transferred to U.K. authorities.

Winners and losers

The United Kingdom’s updated CBD guidance gives manufacturers and retailers clarity on how to sell CBD foods legally.

Legal clarity will change the U.K. market, predicted Robert Cookson, senior consultant at Hanway Associates, a London-based consultancy for marijuana and hemp businesses.

“Power will shift toward CBD suppliers that are actively engaged in obtaining novel foods approval,” Cookson told Hemp Industry Daily.

“They will likely be able to charge a premium for their products, and it’s possible there could even be product shortages in parts of the supply.”And though the deadline requires only that an application be submitted, not approved, the policy will thin the ranks of CBD products in the United Kingdom.

“Getting the application in is one thing; getting approved is another,” Hanway CEO George McBride said.“It can cost millions of pounds to generate the technical information required,” he said.“Of the hundreds of CBD companies operating in the U.K., only a handful have the means for it. We expect this FSA announcement to drive consolidation.”

The U.K.’s Association for the Cannabinoid Industry (ACI) committed its members a few months ago to seek novel food authorization for their CBD products.

The industry group welcomed the FSA decision.“It is critical that the industry now responds by undertaking all the investments required to ensure that we can deliver full regulatory compliance,” Parveen Bhatarah, ACI’s regulatory lead, said in a statement.

Pragmatic enforcement approach

McBride sees the FSA move as “the first of a series of landmark milestones on the route to cannabis reform in the U.K.”He told Hemp Industry Daily that “a potential future blue-sky event for hemp and CBD businesses in the U.K. could be a change to the licensing regime, allowing farmers to extract CBD from hemp.”

The FSA regulates food safety in England, Wales and Northern Ireland, which means the measure doesn’t apply to Scotland, where Food Standards Scotland is the responsible agency.It also doesn’t apply to:Cosmetics.Vapes.Products making medicinal claims.Products containing THC or other controlled drugs.

The FSA also advised pregnant and nursing women “not to consume CBD products” and recommended that healthy adults “think carefully” before taking any CBD, suggesting not to exceed a daily dosage of 70 milligrams, or about 28 drops of 5% CBD oil. The FSA warnings for consumers are based on the results of a report by the United Kingdom’s Committee on Toxicity, a panel of scientists that prepared a CBD review used by the FSA to justify its recent decision.

The Committee on Toxicity report was based on research data from a CBD drug approved by U.S. and European health regulators to treat rare types of epilepsy, Epidiolex.The committee used scientific clinical and nonclinical data of the drug that had been previously used by the health authorities, including the U.S. Food and Drug Administration, for the approval of the medicine.Because that data was intended for pharmaceutical and not over-the-counter use, the committee report noted a “trade-off between risks and benefits that does not apply to food.”

Alan Boobis, chair of the Committee on Toxicity, warned in the report that “there are potential adverse health effects from the consumption of these products.” 資料出處