The Committee would like to express its appreciation to the Taiwan Food and Drug Administration (TFDA) for its continued attention to the cosmetic industry’s issues, as well as its communication and engagement with the industry to work toward resolving those issues.
We also recognize the solid progress the government has made in relaxing the Safety Assessor qualification criteria, namely its proposed expansion of the scope of those qualified to serve as the signatory for product safety reports.
The Committee nevertheless urges the TFDA to take a more transparent, open-minded, and science-based approach to regulating cosmetics and adopting emerging trade models. Removing technical barriers to trade would increase Taiwan’s attractiveness to investors and businesses.
Suggestion 1: Avoid non-transparent or arbitrary review standards for proof of claims for cosmetics products and specify rules regarding consumer-generated content.
1.1 Under Article 3 of the “Regulations Governing Criteria for the Labeling, Promotion, and Advertisement of Cosmetic Products with Deception, Exaggeration, or Reference to Medical Efficacy” (the Criteria), one of the situations defined as constituting a “false or exaggerated claim” is when “the content description has no evidence, or the evidence is insufficient to support such description.” In addition, according to Appendix II of the Criteria, the data supporting the claim must be “objective and fair.”
In the Criteria, a claim that a product is anti-bacterial is one for which objective and fair supporting data is required. In 2017 the TFDA published the “Limits and Regulations on Anti-bacterial Agents Used in Cosmetics” (the Regulations), listing ingredients with anti-bacterial properties and the percentage of such ingredients allowed in cosmetics products regulated by the TFDA. We urge the TFDA to permit the claim that certain cosmetics products are anti-bacterial as long as one or more of the ingredients listed in the Regulations is included in the products’ formulas and the concentration of such ingredients meets the standards set out in the Regulations. This topic was raised in the 2021 Taiwan White Paper, but the Committee did not receive a direct response from the competent authorities.
The Criteria also require such data for claims that a product is anti-acne. However, when the industry has provided in-vitro acne bacillus test results to substantiate such claims, they were rejected by the health authorities on the grounds that the results could not prove the efficacy of the products in question on the human body. If in-vitro acne bacillus test results do not constitute “objective and fair” data to substantiate anti-acne efficacy, the Committee is unclear as to what would.
We urge the TFDA to follow international best practices in evaluating product claims for cosmetics and accept widely adopted tests as supporting data. Doing so would allow cosmetics companies to provide accurate information about their products without being subjected to the vague requirement to provide “objective and fair” data to back up such information.
1.2 Sharing information about consumer products online is a widespread trend. Consumers actively leave comments about usage experiences or suggestions to a brand on its official website, social media page, or fan page. The Committee’s member companies respect the public’s input and do not modify or delete reviews or comments left by consumers. However, local health authorities consider such comments to be advertisements by nature. When health bureau inspectors deem certain comments a violation of relevant regulations on advertising, they impose administrative penalties on the cosmetic company, even when the comments in question were not deliberately created jointly by consumers and the company. We therefore urge the competent authorities to clearly distinguish between public comments and advertising matter, while taking into consideration
that people’s freedom of speech is a fundamental constitutional right.
Suggestion 2: Relax regulations governing the production and sale of customized cosmetics.
Providing consumers with the ability to customize their cosmetics products by choosing ingredients according to skin conditions or personal preferences is a globally established trend in the cosmetics industry. It allows companies to create unique products that may be better suited to consumers’ needs than off-the-shelf products. A popular method is to have trained and certified staff blend and repackage the product on-site at retail stores.
As mentioned in the 2021 Taiwan White Paper, the U.S. Food and Drug Administration provides industry guidelines and a Good Manufacturing Practice (GMP) checklist for the inspection of customized products, which has allowed many brands to offer such products to U.S. consumers. In the EU, Cosmetics Europe (CE), France’s FEBEA, and the German Cosmetic, Toiletry, Perfumery and Detergent Association (IKW) have provided voluntary guidelines for their members to follow regarding customized cosmetics. In addition, South Korea’s new cosmetics laws allow companies to sell personalized cosmetics after obtaining a specific license, with the customization conducted by certified personnel. In Japan, personalized cosmetics can be made and sold in stores as long as the premises pass a government audit and the company has obtained a manufacturing license.
The Committee is very grateful to the TFDA for its open-mindedness in discussing this issue, which affirms the government’s efforts to harmonize Taiwan’s regulations with international trends. We look forward to continuing our discussions with the TFDA and urge it to relax relevant regulations and remove barriers to this new business model. Doing so would encourage further growth of the cosmetics industry and stimulate economic development in Taiwan.
Suggestion 3: Permit the refilling of cosmetics product containers for the sake of waste reduction and environmental protection.
As companies and governments globally implement measures to combat climate change, the Taiwan government has also demonstrated its determination to promote the United Nations’ Sustainable Development Goals and reduce carbon emissions and waste. In 2016, the Executive Yuan’s cross-ministerial Office of Energy and Carbon Reduction was established to promote environmental protection. Similarly, cosmetics companies worldwide have also implemented specific environmental, social, and governance (ESG) measures to contribute to protection of the environment.
One such example is the collection and reuse of cosmetic containers. Reusing containers – including the refilling of cosmetics bottles – is an effective means of reducing waste and protecting the environment. Consumers bring their empty cosmetics products to the store, which refills them from a bulk-sized container. Allowing this service would assist the government in reaching its net-zero ambitions as well as reducing public waste-disposal costs.
As with customized cosmetics, refilling is allowed in many major markets, including the U.S., EU, and South Korea. In addition, the ASEAN Cosmetic Association is in the process of drafting guidelines for refilling products in-store. Among ASEAN countries, the Thailand FDA has on several occasions discussed the refilling of liquid perfumes and body and hair-cleansing cosmetics with industry representatives. Based on the resulting consensus, draft regulations on refilling cosmetics containers are expected to be announced in Thailand in the near future.
This issue was raised in the 2021 Taiwan White Paper but so far, no significant progress has been made toward developing new regulations. We urge the TFDA to support the environmentally friendly practice of refilling cosmetics product containers by announcing regulations and guidelines that draw on existing international standards.
化粧品委員會感謝衛生福利部食品藥物管理署(下稱:「食藥署」)對化粧品行業問題的持續關注,以及食藥署與化粧品業者的溝通和參與,以努力解決業界問題。
我們表彰政府在放寬化粧品安全資料簽署人員資格方面有具體的進展。
我們敦促食藥署採取更加透明、開放和基於科學的方法來監管化粧品並接受新興的貿易模式,以避免貿易技術壁壘,並增加台灣對投資者和企業的吸引力。
建議一:就有關化粧品效能宣稱證明之民眾自行留言與評論之審查,採用客觀且公正之判斷標準
1.1 根據《化粧品標示宣傳廣告涉及虛偽誇大或醫療效能認定準則》(下稱:「本準則」)第三條,「無證據,或證據不足以佐證」被定義為構成「虛偽或誇大宣稱」的其中一種狀況。此外,根據本準則附件二,可佐證宣稱的資料應「客觀且公正」。
在本準則中,抗菌宣稱就是必須提供客觀且公正試驗數據佐證的一種情形。食藥署已於2017年公告《化粧品中抗菌劑成分使用及限量規定基準表》(下稱:「抗菌劑基準」),在抗菌劑基準中訂定具抗菌效果的成分與其允許使用的百分比。我們極力主張只要化粧品的配方中含有一種或多種列在抗菌劑基準中的成分,且濃度符合規定,即得宣稱抗菌。本商會已於2021年白皮書提出此主張,但未收到主管機關正面回應。
此外,本準則中抗痘宣稱也是一種需要提供客觀且公正數據的狀況。然而,當企業提供體外痤瘡桿菌試驗作為佐證時,卻因政府官員認為這類試驗無法證明對人體有效,而無法被衛生機關接受。倘若體外痤瘡桿菌試驗尚不夠成為「客觀且公正」可作為抗痘功效之佐證,委員會實無可參考之依歸。
我們敦促食藥署評估產品宣稱時,遵循國際最佳實務並接受廣泛採用的試驗作為佐證,此舉可使化粧品公司提供確切產品資料,而不至陷於「客觀且公正」模糊定義情境中。
1.2 在網路上分享有關消費品的資訊是一種普遍趨勢,常有消費者主動在品牌官網、社交媒體或粉專頁面上對產品的使用體驗或建議進行評論。化粧品委員會之會員公司對於民眾留言皆持尊重之態度,不會修改或刪除。但是,地方衛生機關認為此類評論本質上屬於廣告,當地方衛生局廣告稽查人員認為某些評論違反了相關廣告的規定時,即使該等評論並非消費者和業者故意共同實施,他們也會對業者處以行政罰。因此,我們敦促主管機關明確區分公眾評論和廣告,同時考慮到人民言論自由是一項憲法基本權利,俾利業者因應遵循。
建議二:鬆綁客製化粧品之生產與銷售法規
客製化粧品已經是國際間業界廣泛建立的趨勢,有時化粧品公司特製的產品比現成產品更能滿足消費者需求,常見的做法是由受過訓練認證的店員在販售現場將產品進行混合或重新包裝。
如同本委員會2021年白皮書中所述,美國的食品藥物管理局提供產業指南和 GMP查檢表,故許多品牌已經有客製化粧品的業務。在歐洲,歐洲化粧品協會(CE)、法國的美容企業聯合會(FEBEA)和德國的化粧品、香料及清潔劑協會(IKW)為其成員提供自主指南以供客製化粧品時遵循。韓國的新化粧品法規允許化粧品公司在經過認證,且由領有執照者執行化粧品客製的情況下,即可銷售個人客製化的化粧品。在日本,只要經營場所通過政府稽核且化粧品公司獲得生產許可,便可在店內製作和銷售客製化粧品。
本委員會非常感謝食藥署持開放的態度,就此議題與商會進行討論,商會對政府就台灣法規與國際趨勢協和化的努力表達肯定。本委員期待持續與食藥署溝通,並敦促其放寬相關規定,消除這種新商業模式的障礙,促進台灣化粧品市場成長並刺激經濟發展。
建議三:為了減少垃圾與環境保護,允許化粧品空容器再充填
隨著全球企業和政府採取措施應對氣候變化,台灣政府也表現出推動聯合國可持續發展目標和減少碳排放和浪費的決心,於2016年成立跨部會的「行政院能源及減碳辦公室」,推動環保工作。同樣,全球化粧品業者也實施了具體的環境、社會和治理(ESG)計畫,為環境保護而貢獻。其中一例就是化粧品容器的收集與再利用。重複使用容器(包括重新充填化粧品空瓶)是減少浪費和保護環境的有效方式。消費者將空化粧品容器帶到商店,商店再從一個大容器中將其重新裝滿。允許這項服務將有助於政府實現其淨零排放目標並降低公共廢物處理成本。
就如客製化粧品一樣,一些主要市場如美國、歐洲、韓國等皆允許化粧品的再充填。在東協國家,其化粧品協會正在草擬在店內再充填產品的指導方針;其中,泰國已經針對液態香水及液態身體與頭髮清潔用化粧品再充填之議題與業界多次討論並達成共識,預計近日將公告相關法規之草案。
我們敦促食藥署支持對環境友善的化粧品再充填的作業,公告與國際標準協和化的法規和指南。
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