Many companies are turning to the production of anti-epidemic supplies in light of the spread of novel coronavirus across the globe and the predicament of local economy. Among those supplies, hand sanitizers are preferred by many export-oriented manufacturers due to its low production costs and has minimal requirements on equipment and production process. To exploit market of hand sanitizers in Europe and America, it is necessary to understand the technical requirements in these regions. To assist with understanding the relevant regulatory requirements, Intertek together with our experts have summarized key information for our clients, partners and interest bodies.

Hand sanitizers can be divided into two types depending on the usage method.

1. Regular hand wash products
2. No-rinse hand sanitizers: These can further be divided into alcohol-based and non-alcohol-based by its ingredients. Currently, alcohol-based hand sanitizers that meets certain level of alcohol concentration are effective in fighting against the novel coronavirus.

U.S.

Hand sanitizers featuring disinfection function are classified as OTC drugs in U.S. and are regulated by FDA. To accelerate the import and custom procedure for such product, FDA has published a “Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance” on March 20^th. Relevant provisions were in effect immediately and the expiration date is yet to be determined.

For Hand sanitizers that are eligible, Intertek can provide relevant testing and certification as listed below:

• Determining ethanol/isopropanol content
• Antibacterial activity test
• Ingredient and labelling review for OTC products
• Testing the raw materials such as glycerin according to USP requirements
• cGMP certification
• Factory and product registration
• Safety Data Sheet

EU

Hand wash products without disinfection function are classified as cosmetics and are regulated according to (EC)No.1223/2009. On the other hand, hand sanitizers with disinfection function are considered as biocidal products and are regulated according to the Biocidal Product Regulation (EU)528/2012. This is also known as BRP. BPR aims to unify the operation and management of the EU biocidal product market to protect human health and environment.

BPR is under joint control by the European Chemicals Agency and the administrative agencies of EU member countries. BFR provides a framework but actual compliance requirement will vary depending on member countries. Such products must be registered with and authorized by relevant surveillance authorities before being placed on the market.

Intertek can provide pre-assessment on formula ingredient and propose solutions to comply with specific regulations, including:

• Providing consultation and suggestion
• Preparing registration documents
• Constructing test plans, monitoring product quality such as but not limited to alcohol content, antibacterial activity test etc.
• Ingredient and labelling review
• Communicating with relevant government authorities on registration and authorization, submission of documents, etc.

Reminder

To further strengthen quality supervision over the exports of supplies out of China, the Ministry of Commerce joint with the General Administration of Customs and the National Medical Products Administration published a special announcement. According to this announcement, manufactures must first obtain national hygiene license to export disinfection products. Secondly, their product must comply with the quality standard requirements of the import countries (regions). Therefore, in terms of production qualifications, organizations and individuals engaged in the manufacturing and packaging of disinfection products in China must apply for the Hygiene License according to the Regulation for Hygiene Licensing of Disinfection Product Manufacturers.

Currently, most hand sanitizers contain alcohol concentration as high as 75% or 80%, and alcohol is classified as hazardous chemicals. Hence, in addition to the hygiene license, these products must obtain the appraisal result for the Transportation, Packaging and Use of Hazardous Outbound Goods (referred to as the Hazardous Goods Packaging Certificate).

For more information, please contact:

SC

0755-2602 0151

0755-2602 0369

020-3210 2492

EC

021-5339 6228

NC

022-8371 4973

service.china@intertek.com

About Intertek

Intertek is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories and offices and more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification solutions for our customers’ operations and supply chains. Intertek Total Quality Assurance expertise, delivered consistently with precision, pace and passion, enabling our customers to power ahead safely.

www.intertek.com.cn