By Veronica Marrero, Regulatory Compliance Specialist
If you are like many of our customers, you may be trying to navigate a new world of manufacturing hand sanitizers or other disinfectant products. Many businesses can modify day-to-day operations to produce these in demand products such as breweries, distilleries, coatings manufacturers and other manufacturing and distribution businesses. For some, working with hazardous chemicals may be a new occurrence and we are here to help!
Effective alcohol-based hand sanitizer for consumer use is made up of at least 60% alcohol, such as isopropyl alcohol, ethyl alcohol or n-propanol. However, the optimal alcohol concentration is 70-95%. It is also important to note that not all suppliers of these alcohol components will be the same. The concentration of the alcohol and the differing impurities are important to take note of. Supply chains should do their best to procure 90-99% pure alcohol so that when mixed with the other components, the concentration will stay above the 60-70% minimum.
Keep in mind that these new chemicals need to be added to your SDS Binder, your chemical inventory list and precautions made known to your employees. Precautions could include flammability, explosive warnings and required PPE when handling the hazardous ingredients. An SDS will also need to be created to maintain compliance. We are authoring SDSs for these products, please contact us for more information.
The United States
In the United States, alcohol-based hand sanitizers are regulated by the FDA as over-the counter (OTC) drugs. Last year, the FDA issued a final rule (in its OTC monograph for consumer hand sanitizers) that establishes 28 active ingredients as unacceptable to use in OTC hand sanitizers. The listing of these 28 banned ingredients can be found here. This means that if you want to use any of these active ingredients in OTC hand sanitizers that you want to market in the US, you’re required to submit a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) to the FDA.
The high demand and urgent need for hand sanitizers in the US due to COVID-19, has led the FDA to relax some of its requirements. Specifically, they released the “Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency” for immediate implementation. Pharmaceutical compounding is defined by the US Pharmacopeia Convention (USP) as “the preparation, mixing, assembling, altering, packaging, and labeling of a drug, drug-delivery device, or device in accordance with a licensed practitioner’s prescription, medication order, or initiative based on the practitioner/patient/ pharmacist/compounder relationship in the course of professional practice.” Under this Guidance, compounders may prepare alcohol-based hand sanitizers, including hand rubs, for consumer use and health care personnel as long as the provisions of the Guidance are followed.
In Canada, alcohol-based and sanitizers containing ethanol or isopropyl alcohol are classified as natural health products (NHPs) and are regulated under the Natural Health Products Regulations (NHPR). The NHPR requires a site license to manufacture, package, label and/or import such products in Canada. Further, in order to legally distribute (and/or donate) NHP hand sanitizers in Canada, a product license is required.
Currently, hand sanitizers in Canada may not fully meet the current regulatory requirements due to the urgent need and high demand of these products in mitigating the spread of COVID-19. To allow for quicker access to these products, Health Canada has implemented interim measures that makes these products available despite not meeting all regulatory requirements. This includes simplifying and expediting the processes to acquire site and product licenses. Health Canada has published a list of products, including hand sanitizers, that are accepted under the COVID-19 interim measure.
The European Union
In Europe, alcohol-based hand sanitizers are regulated as biocides/biocidal products under the Biocidal Products Regulation (EU) No. 528/2012. These biocides require authorization prior to being placed on the EU market. And, although there’s the additional requirement that the active substances contained in these biocidal products be previously approved, you can place the product on the market if its active substance is in the Review Programme, pending a final decision on approval. The use and market placement of such products without approved active substances are subject to national (Member state) laws. An example of such products are hand sanitizers with Ethanol as the active ingredient; the ECHA listing can be found here.
Article 55 (1) of the BPR addresses what to do if there is a need to place products on the EU market that do not fully meet the conditions for authorization required under this regulation, where the need is “because of a danger to public health, animal health or the environment which cannot be contained by other means.” ECHA is advising companies that are looking to quickly place biocidal products, such as alcohol-based hand sanitizers, on the market to use the health danger provision of Article 55 (1).
Global Safety Management is here to help you navigate these regulations as we shift to produce these much-needed essentials. Please contact us today if we can assist you.