In order to alleviate shortages, competent authorities support countries and companies to ensure that disinfectants can quickly enter the market.
Following the WHO (World Health Organization) declaration that the new coronavirus (COVID-19) is a pandemic, the most recommended method to prevent COVID-19 spreading is the frequent practices of disinfection and handwashing. The use of hand cleaners and hand disinfectants in forms of gels, hand wipes or other leave-on products has increased dramatically in the last weeks and this has resulted in general shortages across many countries.
Possibilities for fast track authorizations for disinfectants and hand sanitizers have been approved in some countries.
In Europe, if your product contains active substances such as ethanol, chlorine, or quaternary ammonium compounds, as these are still not approved under the Biocidal Products Regulation (BPR) then the transitional period will apply. The transitional period will make it possible to immediately market your product after notification in some EU countries, and within a few weeks.
Also, due to the sanitary emergency, the EU countries can currently allow the launching of disinfectant products in the market under specific conditions according to Art. 55 (1) of the BPR:
‘By way of derogation from Articles 17 and 19, a competent authority may permit, for a period not exceeding 180 days, the making available on the market or use of a biocidal product which does not fulfil the conditions for authorization laid down in this regulation, for a limited and controlled use under the supervision of the competent authority, if such a measure is necessary because of a danger to public health, animal health or the environment which cannot be contained by other means.’
ECHA provides some information here
In USA, the U.S. Food and Drug Administration (FDA) does not intend to take action against compounders, firms, pharmacists in State-licensed pharmacies or Federal facilities, that prepare alcohol-based hand sanitizers for consumer use in violation of specific sections of the Federal Food, Drug, and Cosmetic (FD&C) Act and Public Health Service (PHS) Act, for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, provided specific circumstances are present.
For instance, the compounder must compound hand sanitizers only using the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with WHO recommendations.
The compounder should not add any other ingredients in order to preserve the safety and effectiveness of the product.
Also, the FDA is specifying interim levels of certain impurities (like benzene, coming from the manufacturing process or the use of certain chemicals, equipment or containers) that have been determined to be tolerated for a relatively short period of time during the COVID-19 public health emergency to avoid access issues for alcohol-based hand sanitizer.
- Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry
- The Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency
- Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)
WHAT ABOUT SOZIO ?
As relevant needs and circumstances evolve, the relevant Authorities intend to update, modify or withdraw these policies as appropriate.
As an essential business providing fragrances and materials for both the consumer and industrial cleaning industries, Sozio is doing its best to support our partners and customers that are directly fighting back against this deadly epidemic by remaining open to service your needs.
As the spread of the virus has overtaken the efforts to reduce its momentum, Sozio has responded to the many customer inquiries looking for quick-to-market solutions to increase the fight. In support of those who are manufacturing disinfecting, cleaning, and/or health and hygiene products, we have assembled collections of tested and approved fragrances that are stable in technical bases for different product categories. Some fragrances are U.S. Environmental Protection Agency (EPA) registered and approved by Lonza, Stepan Company and Pilot Chemical to be used in their bases. Sozio offers also Safer choice fragrances.
During this unprecedented health crisis, our hearts are with everyone that has been affected by the epidemic.
We are all in this together and must learn, evolve, adapt and help care for each other. If you are interested in receiving additional information or samples of the collections, or if Sozio can help in any way, please do not hesitate to contact us.
Hoping that everyone remains safe, healthy and optimistic that we will get through this together.
Sozio teams are continuing their efforts to keep business as normal as possible during this unusual time.
Also, we would like to thank the professional Associations to which we belong for always providing us with very helpful information on highly topical issues of major importance like the changed regulatory landscape during the COVID-19 crisis.
If you have any questions or are looking for more information, don’t hesitate to reach out to us via email: firstname.lastname@example.org or through your designated Sales Representative.