Regulatory Status of Wet Wipes Used on Human Body in Europe,United States, Canada, Australia and China

Li Zhongrui, Li Neng, Li Xia

Intertek Testing Services Shenzhen Ltd., China

Introduction

In recent years, more and more consumers choose wet wipes as their daily cleaning products because they are easy to use and carry with. There are different types of wet wipes currently on the market, for example cleaning wipes, hygiene wipes, anti-bacterial wipes and baby wipes,etc. Some wet wipes may use special claims to attract specific consumers, thus it is quite normal to have claims such as “Non parfum”, “Non-alcohol”, “Non-fluorescent agent”, “Non-impurity and microorganism”, “Nature and additive free” on product labels.

Wet wipes are divided into two groups: used for human body and used for objects. Wet wipes used for human body include regular wipes (mainly for cleaning,perfuming and protecting) and hygiene wipes, while wet wipes used for objects include the ones for tableware, bath and toilet supplies and so on.[1]Compared to cosmetics,wet wipes are more complicated and need to rely on medias (such as non-woven, paper) to be applied on human body, further they are under different regulations in different countries. The knowledge on wet wipes regulations especially for foreign countries of Chinese manufactures is limited, which may result in them being subject to severe economic and reputation losses. We collected and studied the regulatory status of wet wipes in Europe, United States, Canada, Australia and China to help companies to better understand the relevant regulations and further to reduce the risk of being noncompliant.

Europe

EC Cosmetic Regulation No.1223/2009[2]incorporates the following defination of a cosmetic product: a “cosmetic product” shall mean any substance or mixture intended to be placed in contact with the various external parts of the human body (skin, hairs, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them, keeping them in good condition.According to section 1.6 of the Manual on the scope of application of the cosmetic regulations (version 1.0),[3]a wipe may be the “vehicle” to deliver a substance or preparation to the human skin, and falls within the scope of application of the Cosmetics Regulation. In addition, a cleaning wipe was recalled as a cosmetic product which was published on Europe Rapid Alert System on 26 July 2013.[4]

Overall, wipes that are used mainly for cleaning, perfuming and protecting are regulated as cosmetics. The use of raw materials should comply with Annex II and Annex III,the colorants should follow the requirements in Annex IV,and the preservatives should be listed in Annex V of EC Cosmetic Regulation.

The United States

Federal Food, Drug, and Cosmetic Act (FD & C)[5]defineds cosmetics as: a) articles intended to be rubbed,poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance; b) articles intended for use as a component of any such articles, except that such term shall not include soap, while drugs are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; c) articles(other than food) intended to affect the structure or any function of the body of man or other animals.

According to Disposable Wipes on Food and Drug Administration (FDA) website,[6]the administration of disposable paper towels and wet wipes are depended on their intended use.

Wipes intended for cleansing or moisturizing the skin, such as those for baby care, hand washing, makeup removal, washing the body when bathing is not practical,or female hygiene or other personal cleansing, are regulated as cosmetics. So are wipes intended for applying products such as sunless tanners or deodorants. Wipes intended for a therapeutic purpose, such as killing germs on the skin, or treating acne, diaper rashes, or other skin conditions, are drugs under the law. Drugs must meet requirements for FDA approval for safety and effectiveness before they go on the market. Wipes containing pesticides or insect repellants are regulated by the Environmental Protection Agency. Wipes intended for disinfecting and cleansing objects in our homes, at work, the gym, and in public places are regulated by the Consumer Product Safety Commission.

Whether a product is a cosmetic under the law is determined by a product’s intended use, which is determined by product statements and consumer perceptions. According to FD & C Act, a product could be both kind of cosmetics and drugs (either cosmetics or drug in Europe). If a cleaning wipe is regulated as cosmetics, the use of raw materials should comply with Prohibited & Restricted Ingredients and colorants should be in Color Additives Permitted for Use in Cosmetics.In addition, the packaging must comply with applicable regulatory requirements such as the Fair Packaging and Labeling Act (FPLA), Cosmetic Labeling, Cosmetic Label Warnings and Cosmetic Labeling Guide.

Canada

In Food and Drugs Act,[7]cosmetics includes any substance or mixture of substances manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth, and includes deodorants and perfumes. It should be noted that this definition does not specify it has to be used on human body, thus products used on animals also fall within this regulation.

Drugs include any substance or mixture of substances manufactured, sold or represented for use in: a) the diagnosis, treatment, mitigation or prevention of a disease,disorder or abnormal physical state, or its symptoms,in human beings or animals; b) restoring, correcting or modifying organic functions in human beings or animals;c) disinfection in premises in which food is manufactured,prepared or kept.

Notification of Cosmetics[8]published by Health Canada lists cosmetic examples of soaps, artificial nail builders, adhesives such as for artificial nails and hair extensions, moisturizers (including tinted moisturizers),tattoo inks (chemicals in Europe), cleansing wipes, and etc. As can be seen, cleansing wipes are included in the regulation of cosmetics in Canada, however, antiseptic wipes are considered as Over-The-Counter Drug based on Topical Antiseptic Products-Risk of Infection[9]published by Health Canada on 25 July, 2014.

Australia

The Trade Practices (Consumer Product Information Standards) (Cosmetics) Regulations 1991[10]defines cosmetic product as a substance or preparation intended for placement in contact with any external part of the human body, including the mucous membranes of the oral cavity; and the teeth; with a view to altering the odors of the body; or changing its appearance; or cleansing it;or maintaining it in good condition; or perfuming it;or protecting it. Cosmetics are regulated by Australian Competition and Consumer Commission (ACCC), while drugs are under the supervision of Therapeutic Goods Administration (TGA).

The Therapeutic Goods Act 1989[11]defines therapeutic goods as:

(1) goods that are represented in any way to be, or that are, whether because of the way in which the goods are presented or for any other reason, likely to be taken to be for therapeutic use; or for use as an ingredient or component in the manufacture of therapeutic goods; or for use as a container or part of a container for goods.

(2) included in a class of goods the sole or principal use of which is, or ordinarily is, a therapeutic use or a use and includes biologicals, medical devices and goods declared to be therapeutic goods.

Whether a product is a cosmetic or a therapeutic good under the law is determined by its use purpose and claims.Normally, a therapeutic good usually has a purpose of therapy including modifying organic functions, thus products have claims such as relieving rash, curing acne,contributing to the skin tissue repairing are considered as therapeutic goods.

So far, there are no specific provisions or relevant explanations about wet wipes for human use in Australia,however, they should be considered as cosmetics and should comply with cosmetic requirements based on the cosmetic definition and industry practices.

China

The Regulation concerning Hygiene Supervision over Cosmetics (Decree No.3 of MOH)[12]published by Ministry of Health (National Health and Family Planning Commission) on 13 November, 1989, defines a cosmetic product as “those daily-used industrial chemical products applied on the surface of any part of the human body(such as epidermis, hair, nails and lips) to keep the body clean; to correct body odors, to protect the skin,to increase the beauty of appearance”. GB 5296.3—2008 Instruction for Use of Consumer” Products—General Labeling for Cosmetics[13]published by General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) on 16 June, 2008, defines cosmetic as “products that intended to be rubbed, poured,sprinkled, or sprayed on the external part of the human body (such as skin, hair, nails and lips) for cleansing,perfuming, altering the appearance, correcting body odors, protecting and keeping them in good condition”.

At present, to regulate wet wipe products, China has introduced the national standard GB 15979-2002 Hygienic Standard for Disposable Sanitary Products[14]and the recommend standard GB/T 27728-2011 Wet Wipes.[15]

According to GB 15979-2002, disposable hygiene products refer to all kinds of daily necessities (liquid or solid) discarded after one use, that be applied on human body directly or indirectly, with intention for physiological and healthcare hygiene (antibacterial or bacteriostatic),such as disposable gloves or finger cots (not including medical gloves or finger cots), paper towels, wet wipes,sanitary wipes, etc. It can be seen that wet wipes belong to disposable hygiene products in China for now.

GB/T 27728-2011 is a further refinement of the provisions in GB15979-2002 which refers specifically to wet wipes,specifies the categories, requirements, testing methods,inspection rules, labelling and packaging, transportation and storage, etc.

Wet wipes belong to the scope of cosmetics in the regulatory point of view, however, in the current actual supervision they have not been regulated in accordance with cosmetic standards.

Discussions

On 15 September 2015, CCTV Weekly Quality Report united Shanghai Consumer Protection Committee and did microbiology and preservative inspection on 50 wet wipe samplings that they collected.[16]

The microbiological quality was tested in accordance to the national standard GB15979-2002 and GB/T 27728-2011, in which the total bacterial colony count should not exceed 200 CFU/g (or CFU/mL), total fungi colony count should not exceed 100 CFU/g (or CFU/mL), and coliform bacteria and pathogenic pyogenic bacteria(Pseudomonas aeruginosa, Staphylococcus aureu and hemolytic streptococcus) should not be detected. The result showed that the total bacterial colony counts of 2 samples were above the threshold.

Due to lack of specific requirements in the above two standards, the preservative testing is referenced to European standards on Methylisothiazolinone (MI) and Methylchloroisothiazolinone (CMIT) in Cosmetics. On 18 September 2014, European Commission published(EU) regulation No 1003/2014[17]to amend the Annex V of Cosmetic Regulation EC No 1223/2009 and restricted the use of MI and CMIT in Cosmetics: mixture of MI and CMIT in a ratio of 3:1 up to a maximum authorized concentration of 0.0015 % in rinse-off cosmetic products, while MI should not be above 0.01% in cosmetics. Wipes are usually leave-on products,thus MI should not exceed 0.01% and CMIT should not be detected. However, the results displayed that MI in 2 samples was above the theshold, while CMIT was detected in 21 samples of which 12 were baby wipes(25 of the samples were baby wipes). In addition, some products that detected MI and CMIT have claims of “no irritation”, “additive free” and “applicable for sensitive skin”, etc.

Actually there are restrictions on the use of MI and CMIT in cosmetics in China. Hygiene Standard for Cosmetics (2007) stipulates that maximum concentrations of MI in cosmetics should not exceed 0.01% and the mixture of CMIT and MI with magnesium chloride and magnesium nitrate should not be above 0.0015%. No. 32 in Table 4 of Safety and Technical Standards for Cosmetics(2015)[18]restrictes the mixture to be used in rinse-off cosmetics only and forbidden it to be used with MI at the same time.

Nowadays, with highly developed social networks and social media, the general public are better informed,and according to market research performed by some nonprofit organizations, are demanding using tougher standards to test and assess the safety of products.Although, products on the market, which have complied with Chinese government regulations, are considered“unsafe” by consumers, which may lead consumers to lose confidence in domestic products and bring significant negative impacts on the development of wipes industry in China. Therefore, we suggest to regulate domestic wipes under cosmetics with references to the regulations and administrations of other countries/districts (Europe,United States, Canada and Australia), to standardize market, improve industry development and protect consumers. Meanwhile, manufactures should study the relevant cosmetic regulations, design and produce products according to cosmetics standards to achieve sustainable development goal.

[1] GB/T 27728-2011: Wet Wipes. Beijing: General Administration of Quality Supervision, Inspection and Quarantine of The People’s Republic of China / Standardization Administration of The People’s Republic of China 2011.

[2] European Union. Regulation(EC) No 1223/2009 of the European parliament and of the council of 30 November 2009 on cosmetic products. Official Journal of the European Union 2009, L342: 59-209.

[3] RAPEX. Europe rapid alert system. (Accessed Jul. 26, 2013).http://ec.europa.eu/consumers/safety/rapex/alerts/main/index.cfm? event=main.weeklyOverview&web_report_id=660&selectedTabIdx=3.

[4] European Union. Regulation(EC) No 1223/2009 of the European parliament and of the council of 30 November 2009 on cosmetic products. Official Journal of the European Union 2009, L342, 59-209.

[5] US House of Representatives: Federal Food, Drug, and Cosmetic Act. United States, 1938.

[6] Disposable wipes. http://www.fda.gov/cosmetics/productsingredients/products/ucm441465.htm. (Accessed Jun. 12, 2015).

[7] Food and Drugs Act. Minister of Justice, Canada, 1985.

[8] Notification of Cosmetics. http://www.hc-sc.gc.ca/cps-spc/cosmet-person/notification-declaration/index-eng.php.(Accessed Jul. 23, 2014).

[9] Notification of Cosmetics. http://www.hc-sc.gc.ca/cps-spc/cosmet-person/notification-declaration/index-eng.php.(Accessed Jul. 23, 2014).

[10] Trade practices (consumer product information standards)(cosmetics) regulations. Department of the Treasury, 1991.

[11] Therapeutic goods act. Department of Health Australia, 1989.

[12] The Regulation on the Hygiene Supervision over Cosmetics.Ministry of Health (National Health and Family Planning Commission), 1989.

[13] GB 5296.3-2008: Instruction for Use of Consumer Products—General Labeling for Cosmetics. General Administration of Quality Supervision. Inspection and Quarantine of the People’s Republic of China, 2008.

[14] GB 15979-2002: Hygienic Standard for Disposable Sanitary Products. Beijing: General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China/Standardization Administration of the People’s Republic of China, 2002.

[15] GB/T 27728-2011: General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China / Standardization Administration of the People’s Republic of China, 2011.

[16] Weekly Quality Report. http://www.315.sh.cn/test/detail.aspx?id=26 (Accessed Sep. 15, 2015).

[17] Commission Regulation (EU) No 1003/2014 of 18 September 2014 amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products.http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELE X:32014R1003&from=EN (Accessed Sep.18, 2014).

[18] Decree No.268 in 201: Safety and Technical Standards for Cosmetics. China Food and Drug Administration, 2015.