The year 2020 has been an interesting one so far, to say the least. Coronavirus disease 2019 (COVID-19), the infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has spread around the world, resulting in a global pandemic. This has forced many of us to reconsider the way we live, socialize and do business. Back in March, Nexreg transitioned to a completely virtual workforce to continue delivering chemical regulatory services to our clients while staying safe at home in these uncertain times.
The spring and summer months brought a whirlwind of new activity to the hazardous chemicals sector. Unsurprisingly, demand has slowed in certain areas as the needs of the market shift. Many countries and states implemented emergency lockdown measures and mandated shutdowns for businesses deemed non-essential.
For those chemical companies able to adapt, new opportunities could be found by changing course and entering different areas of the industry. We saw and expect to continue seeing a surge of new products, especially hand sanitizers and surface disinfectants, as companies move swiftly to meet the demands of the changing global market.
When handwashing is not possible, hand sanitizers are an effective way to kill a broad range of microorganisms including SARS-CoV-2. Similarly, disinfectants can be used to sanitize high-traffic surfaces such as door handles, to mitigate the spread of COVID-19. Disinfectants and sanitizers have antimicrobial properties and are regulated in many countries under biocide or drug regulations, which call for specific label elements and product registration. Since the supplier obligations for these products can differ from those of other hazardous chemicals, it is essential to understand the regulatory requirements before selling them in any country.
Labeling & registration requirements
Antimicrobial products are a new market for many companies and navigating the compliance requirements can be challenging. This section will provide a basic overview of the supplier obligations for hand sanitizer and surface disinfectant products.
The U.S. Environmental Protection Agency (EPA) regulates surface disinfectants under the Federal Insecticide, Fungicide & Rodenticide Act (FIFRA). Disinfectants must be registered with EPA as a pesticide and there are specific labeling requirements. Additionally, in the State of California there are website disclosure requirements enforceable under the California Right to Know Act (SB-258).
The U.S. Food & Drug Administration (FDA) regulates most hand sanitizers as drugs under the Over the Counter (O-T-C) Drug Regulations. Registration is required and a drug facts chart must appear on the product label.
Health Canada regulates surface disinfectants as non-prescription drugs under the Food & Drug Act. Product registration is required and a Drug Identification Number (DIN) must be listed on the label. A disinfectant drug application that supports the general safety, efficacy and quality requirements outlined by Health Canada must be submitted to obtain a DIN for a new product.
Health Canada regulates hand sanitizers containing 60–80% ethanol or 60–75% Isopropanol as the active ingredient as Natural Health Products (NHPs) under the Natural Health Products Regulations. Non-alcohol sanitizers with specific drug ingredients such as benzalkonium chloride, are regulated as drugs in Canada under the Food & Drugs Act. In both cases, registration is required and a Natural Product Number (NPN) or DIN must be obtained for NHPs and drugs, respectively. A site licence (SL) is also required to manufacture, package, label and/or import NHPs in Canada.
The European Chemicals Agency (ECHA) regulates surface disinfectants and hand sanitizers under the the Biocidal Products Regulation (BPR, [EU] No. 528/2012). Biocidal products must be authorized by ECHA before they can be placed on the European market. Approval is required for the active substances in the product; and companies must additionally ensure that either their substance, or product suppliers, or themselves are included in the Article 95 list. Article 951 of BPR is a list of relevant active substances and suppliers; raw materials used in biocidal products are not normally permitted to be obtained from suppliers that are not present on the list.
Specific labeling and registration requirements vary depending on the country of sale, so it is important to review the supplier responsibilities before entering a new market.
Interim policies due to COVID-19
The regulatory climate has been constantly evolving over the past several months, with an array of temporary legislative changes being implemented around the world in response to COVID-19. The primary goal of many such changes has been to get essential products on the market quickly so that consumers and businesses have the tools they need to help curb the spread of the virus.
The U.S. FDA released a temporary policy for the preparation of certain hand sanitizer products during the COVID-19 pandemic. The non-binding document states that FDA does not intend to take action against firms that prepare alcohol-based hand sanitizers for consumer use, and for use as health care personnel hand rubs, for the duration of the public health emergency. For the temporary policy to be valid, several criteria must be met:
1. Hand sanitizer must be prepared using the specified ingredients without any additives to improve the smell or taste;
2. It must be prepared under sanitary conditions;
3. It must be manufactured according to formulas consistent with World Health Organization (WHO) recommendations2;
4. The product should be labeled according to the recommendations in the temporary policy; firms are still expected to register their facility and list their products in the FDA Drug Registration & Listing System (DRLS).
The EPA is offering expedited FIFRA registrations for products with active ingredients appearing on list N3: Disinfectants for Use Against SARS-CoV-2.
Health Canada is currently expediting registration applications for hand sanitizer and disinfectant products as well as SLs. Hard surface disinfectants that were authorized and registered in the U.S. and Mutual Recognition Agreement (MRA) and Pharmaceutical Inspection Co-operation Scheme (PIC/S) countries are temporarily authorized for import into Canada. Additionally, to improve the supply of raw materials, the use of technical-grade ethanol in hand sanitizer products has been temporarily authorized, with some additional labeling requirements.
Health Canada further released interim policies to help facilitate access and immediate import of household and workplace cleaning products as well as hand and body soaps. Labels may be in only one official language, and do not have to conform to all the prescribed label requirements to be sold in Canada temporarily. These interim policies will be in effect for three months after all provinces and territories have ended their states of emergency related to COVID-19.
Several European countries took advantage of article 55(1) of the BPR, which allows national authorities to give time-limited derogations from the standard product authorization requirements in situations where there is a threat to public health. In many European States, alcohol-based hand sanitizers with specified formulations could be produced temporarily without completion of a full registration. Additionally, exceptions to the Article 95 supplier requirements were enacted by certain countries to counteract raw material shortages.
How label claims affect regulatory requirements
It is important to note that the claims made on the product label, as well as the identity of non-active ingredients, can impact the regulations that a product is subject to. Hand sanitizer products that make aesthetic claims, such as “softens and moisturizes skin” will frequently fall under cosmetic regulations, depending on the jurisdiction. Cleaning products with biocidal label claims such as “kills 99.9% of bacteria” might be subject to different regulations than a general cleaning product that does not make any such assertions. The applicable regulations and interim policies will vary depending on the product use, formula, label claims and country of sale, so you will want to be sure to check the requirements for your unique circumstance.
It is imperative to ensure that the correct labeling and registration steps are taken when selling hazardous products. Even during these unusual circumstances, recalls can occur for products that are deemed unsafe, which is a costly process that is best to be avoided. As SPRAY goes to press, the temporary policies mentioned in this article were in place. It is unclear where the industry will go and how the regulations will change, but one thing is for sure—consumers want products to keep themselves and their homes safe from COVID-19. Workplaces have new obligations to keep their employees safe as well, which in turn will mean a higher demand for chemical products.
Nexreg will certainly be paying attention to how the market evolves going forward. SPRAY