Notes on Regulations Governing the Export of Biocide Products
Background
Biocide products refer to products that kill pathogenic microorganisms among humans and in the environment we live, or inhibit their growth, or counteract their pathogenic action. Biocide products imported into the US are divided into two categories: antimicrobial pesticides for disinfecting ordinary environmental and hard surfaces, which are regulated by the US Environmental Protection Agency (EPA) and falling within the scope of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA); and antiseptics for disinfecting critical medical devices and different parts of the body (like skin and hand), which are regulated by the US Food and Drug Administration (FDA). This page mainly describes the regulatory requirements for the second category.
Biocide products imported into the EU are subject to the Biocidal Products Regulation (BPR) which sets out explicit rules for Biocide products and their active substances. Biocide products are allowed to be placed on the EU market only if they comply with applicable requirements.
Scope
Biocide products on this page mainly refer to hand sanitizers and wet wipes regulated by the FDA. Only three active ingredients, benzalkonium chloride, alcohol (ethyl alcohol or ethanol, 60%-95%) and isopropanol (70%-91.3%), are eligible for usage.
Biocide products marketed the EU market refer to biocides for human health falling within the scope of the Biocidal Products Regulation (BPR) (Regulation (EU) 528/2012), such as hand sanitizers, gel hand sanitizers and disinfectants for private and public spaces.
Regulations
In the US, Biocide products are over-the-counter (OTC) topical antimicrobial drug products that are regulated by the US Food and Drug Administration (FDA) as OTC drugs, which shall be subject to establishment registration, National Drug Code (NDC) number assignment and drug listing requirements before they are placed on the market. Furthermore, Biocide products shall be manufactured according to the current Good Manufacturing Practices (cGMPs) and conform to the requirements on content and format of labeling under 21 CFR Part 201 Subpart C.
According to the EU BPR, all biocidal products require an authorization before they can be placed on the market, and the active substances contained in a biocidal product must have been approved previously. There are, however, certain exceptions to this principle. There are associated labeling requirements, covering the name and address of the authorization holder, authorized use, authorization number and categories of users to which a biocidal product is restricted. You should also ensure the labels are written in the official language(s) of the Member State(s) in which you offer the product for sale or supply. It is your responsibility to provide accurate and complete product information about biocidal products. In addition to compliance with the BPR, a registration under the EU Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Regulation is required for biocidal products if the non-active substances contained reach the threshold of 1 ton per year and are not included in the Exemption List. Manufacturers shall comply with the Classification, Labeling and Packaging (CLP) Regulation for the classification, labeling and packaging of biocidal products and prepare Safety Data Sheets (SDS) under EU regulations.
Legal Basis
For more information about the US regulations on Biocide products, please refer to:
For more information about the EU regulations on biocidal products, please refer to:
Note: The above information does not constitute any legal advice and shall not be deemed or represent the legal opinion or conclusion of the regulatory body. Further, we do not undertake or warrant that the information represents the latest laws and regulations. For specific information, please consult the competent authority, law firms, or third-party certification/testing/consulting companies in the target country or region.
AliExpress
August 31, 2020