COVID-19

HAND HYGIENE PRODUCTS

Due to the outbreak of coronavirus (COVID-19), there is a high demand for human hygiene products, protective medical devices and personal protective equipment (PPE) in the global market. 

CRITICAL CATALYST is here to help you place your products in the market fully compliant and in the fastest timeframe! 

 

Before exporting or placing hand hygienic products to Europe, the manufacturer should ensure the products are compliant with local regulations and notify/register the products properly.

Alcohol rubs, hand gels or handwashes can be considered as cosmetics in Europe if they do not make any biocidal claims.

If the product makes biocidal claims, it is within the scope of the Biocides Product Regulation (BPR) (EU) 528/2012 and is considered as a Product Type 1 – human hygiene biocidal product.

In general terms, if the product is intended for a cosmetic function and does not include biocidal claims it may considered a cosmetic product, which falls under regulation (EC) nº 1223/2009, on cosmetic products.

    • Responsible Person in the European Union
    • Cosmetic Safety Assessment Report prepared and signed by a qualified Safety Assessor
    • Product Information File (PIF)
    • Label validation
    • Registration in the Cosmetic Product Notification Portal (CPNP)

 

In the United States, Hand Sanitisers are Over-the-Counter drugs that must comply with the requirements set out in the applicable Food and Drug Administration (FDA) monograph and the temporary policy for the preparation of alcohol-based Hand Sanitizer products during the public health emergency (COVID-19).

    • US FDA Agent
    • Formula validation
    • Label validation
    • Labeler Code Request
    • FDA Establishment Registration
    • FDA Drug Listing

 

 

In Brazil, Hand Sanitizers are cosmetics that must comply with the requirements set out by the competent authority – ANVISA (Agência Nacional de Vigilância Sanitária).

    • Registration Holder in Brazil
    • Preparation of dossier and registration of product with ANVISA – Grade II
    • Maintenance of registration

 

OFFICIAL INFORMATION BY AUTHORITIES

Coronaviruses are a large family of viruses which may cause illness in animals or humans.  In humans, several coronaviruses are known to cause respiratory infections ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS). The most recently discovered coronavirus causes coronavirus disease COVID-19.

COVID-19 is the infectious disease caused by the most recently discovered coronavirus. This new virus and disease were unknown before the outbreak began in Wuhan, China, in December 2019. COVID-19 is now a pandemic affecting many countries globally.

You can reduce your chances of being infected or spreading COVID-19 by taking some simple precautions:

  • Regularly and thoroughly clean your hands with an alcohol-based hand rub or wash them with soap and water. Why? Washing your hands with soap and water or using alcohol-based hand rub kills viruses that may be on your hands.

  • Maintain at least 1 metre distance between yourself and others. Why? When someone coughs, sneezes, or speaks they spray small liquid droplets from their nose or mouth which may contain virus. If you are too close, you can breathe in the droplets, including the COVID-19 virus if the person has the disease.

  • Avoid going to crowded places. Why? Where people come together in crowds, you are more likely to come into close contact with someone that has COVID-19 and it is more difficult to maintain physical distance of 1 metre.

  • Avoid touching eyes, nose and mouth. Why? Hands touch many surfaces and can pick up viruses. Once contaminated, hands can transfer the virus to your eyes, nose or mouth. From there, the virus can enter your body and infect you.

  • Make sure you, and the people around you, follow good respiratory hygiene. This means covering your mouth and nose with your bent elbow or tissue when you cough or sneeze. Then dispose of the used tissue immediately and wash your hands. Why? Droplets spread virus. By following good respiratory hygiene, you protect the people around you from viruses such as cold, flu and COVID-19.

  • Stay home and self-isolate even with minor symptoms such as cough, headache, mild fever, until you recover. Have someone bring you supplies. If you need to leave your house, wear a mask to avoid infecting others. Why? Avoiding contact with others will protect them from possible COVID-19 and other viruses.

  • If you have a fever, cough and difficulty breathing, seek medical attention, but call by telephone in advance if possible and follow the directions of your local health authority. Why? National and local authorities will have the most up to date information on the situation in your area. Calling in advance will allow your health care provider to quickly direct you to the right health facility. This will also protect you and help prevent spread of viruses and other infections.

  • Keep up to date on the latest information from trusted sources, such as WHO or your local and national health authorities. Why? Local and national authorities are best placed to advise on what people in your area should be doing to protect themselves.

Non-medical masks

Non-medical masks are often homemade of breathable fabrics and can be commercially available as well. There are numerous designs for fabric masks, but they generally cover the nose and mouth, are secured with ties or elastic loops, include multiple layers of fabric, and can sometimes be washed and re-used.

The evidence about the benefits of these masks is limited. One good quality study showed that the risk of respiratory infection is increased (and not reduced) in health care workers using cotton cloth masks when compared to medical masks. Cloth masks are currently being recommended by some countries as a means of source control in the general population. Although their protective effectiveness to the wearer is unknown, they may protect others if the wearer is a pre-symptomatic or asymptomatic carrier.

Medical masks (also known as surgical masks)

These are made from a minimum of three layers of synthetic nonwoven materials, and configured to have filtration layers sandwiched in the middle. These masks are available in different thicknesses, have various levels of fluid-resistance and two levels of filtration. These medical masks reduce the transfer of saliva or respiratory droplets from the wearer to others and to the environment. They also decrease the likelihood of potentially infectious droplets from others reaching the mouth and nose of the mask wearer.

Hand hygiene should be performed before putting on a clean mask and after removing the mask. These masks should be worn tightly around the chin and top of the nose. The wearer should avoid touching the mask while it is on the face and the mask should be immediately discarded if it becomes moist. Importantly, wearing a mask must be combined with other preventive measures including performing frequent and appropriate hand hygiene and physical distancing of at least 1 metre (3 feet).

Respirators (also known as filtering facepiece respirators –FFR)

Available at different performance levels such as FFP2, FFP3, N95 and N99

These are specifically designed for healthcare workers who provide care to COVID-19 patients in settings and areas where special medical procedures are undertaken. Respirators are intended to protect the wearer when these medical procedures aerosolize smaller particles than normal droplets into the air in the health treatment area. Healthcare workers should be fit tested before using a respirator to ensure that the respirator is sealed tightly on the wearer’s face and is properly fitted. Respirators with valves should not be used as the purpose of source control.

Non-medical masks

Non-medical masks are often homemade of breathable fabrics and can be commercially available as well. There are numerous designs for fabric masks, but they generally cover the nose and mouth, are secured with ties or elastic loops, include multiple layers of fabric, and can sometimes be washed and re-used.

The evidence about the benefits of these masks is limited. One good quality study showed that the risk of respiratory infection is increased (and not reduced) in health care workers using cotton cloth masks when compared to medical masks. Cloth masks are currently being recommended by some countries as a means of source control in the general population. Although their protective effectiveness to the wearer is unknown, they may protect others if the wearer is a pre-symptomatic or asymptomatic carrier.

Medical masks (also known as surgical masks)

These are made from a minimum of three layers of synthetic nonwoven materials, and configured to have filtration layers sandwiched in the middle. These masks are available in different thicknesses, have various levels of fluid-resistance and two levels of filtration. These medical masks reduce the transfer of saliva or respiratory droplets from the wearer to others and to the environment. They also decrease the likelihood of potentially infectious droplets from others reaching the mouth and nose of the mask wearer.

Hand hygiene should be performed before putting on a clean mask and after removing the mask. These masks should be worn tightly around the chin and top of the nose. The wearer should avoid touching the mask while it is on the face and the mask should be immediately discarded if it becomes moist. Importantly, wearing a mask must be combined with other preventive measures including performing frequent and appropriate hand hygiene and physical distancing of at least 1 metre (3 feet).

Respirators (also known as filtering facepiece respirators –FFR)

Available at different performance levels such as FFP2, FFP3, N95 and N99

These are specifically designed for healthcare workers who provide care to COVID-19 patients in settings and areas where special medical procedures are undertaken. Respirators are intended to protect the wearer when these medical procedures aerosolize smaller particles than normal droplets into the air in the health treatment area. Healthcare workers should be fit tested before using a respirator to ensure that the respirator is sealed tightly on the wearer’s face and is properly fitted. Respirators with valves should not be used as the purpose of source control.

The best way to prevent the spread of infections and decrease the risk of getting sick is by washing your hands with plain soap and water, advises the Centers for Disease Control and Prevention (CDC). Washing hands often with soap and water for at least 20 seconds is essential, especially after going to the bathroom; before eating; and after coughing, sneezing, or blowing one’s nose. If soap and water are not available, CDC recommends consumers use an alcohol-based hand sanitizer that contains at least 60% alcohol.

There is currently no evidence that consumer antiseptic wash products (also known as antibacterial soaps) are any more effective at preventing illness than washing with plain soap and water. In fact, some data suggests that antibacterial ingredients could do more harm than good in the long-term and more research is needed.

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COVID-19 NEWS & UPDATES

FDA updates on hand sanitizers safety for use

The U.S. Food and Drug Administration (FDA) has announced that it is providing a new laboratory testing method to assess the quality of finished hand sanitizers. Moreover, the FDA has issued a new press release on August 27th 2020, where it warns consumers about hand sanitizers packaged in food and drink containers. Earlier this month, the FDA expanded hand sanitizer warnings to include 1-propanol contamination.

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Hand sanitizers contaminated with methanol

The new coronavirus SARS-CoV-2 has led to an increasing demand of hand sanitizers. Nevertheless, not all hand sanitizers made available in the market are safe. The U.S. Food and Drug Administration (FDA) has issued a public warning to consumers and health care providers for possible contamination of hand sanitizers with methanol. The FDA advises the public not to use such hand sanitizers, because methanol is a dangerous and toxic substance.

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Airborne transmission is the dominant route for the spread of COVID-19

Transmission pathways of coronavirus disease 2019 (COVID-19) were studied by analyzing the trend and mitigation measures in the three epicenters. Results show that the airborne transmission route is highly virulent and dominant for the spread of COVID-19. The difference with and without mandated face covering represents the determinant in shaping the trends of the pandemic. Mitigation measures, such as social distancing implemented in the United States, are insufficient by themselves in protecting the public.

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