Spain announced: Chinese standards for masks can replace European standards!


Recently, the Spanish Ministry of Industry and SMEs issued a resolution announcing that Chinese mask-related standards can replace European standards.

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In response to the current shortage of the CE-marked personal protective equipment market during the New Coronary Pneumonia epidemic, the Spanish Ministry of Industry and SMEs recently issued a resolution announcing that Chinese mask-related standards can replace European standards.

According to the resolution, during the epidemic, in addition to obtaining the CE mark through compliance with the harmonized standards, Spain will also allow the use of protective masks that comply with the Chinese standard GB 2626 (protection level KN95), but need to comply with the following methods:

First, under the authorization of the Ministry of Health, publicly purchased protective masks without CE mark but in accordance with Chinese standard GB 2626 (protection level KN95) for the use of medical personnel;

The second is that the protective masks without CE mark have been verified by the authorized institution and proved to be in compliance with the Chinese standard GB 2626 (protection level KN95). At the same time, the necessary procedures for obtaining the CE mark are carried out and can be temporarily sold during the epidemic;

The third is to comply with the Chinese standard GB 2626 (protection level KN95) and meet the basic health and safety requirements stipulated in the relevant medical device regulations of the European Union, and obtain the CE mark.

Netherlands announced that some Chinese mask standards are equivalent to European standards

Recently, the official website of the Dutch Health Care and Youth Inspection Bureau announced that in order to ensure the adequate supply of personal protective equipment and medical device products during the outbreak, the Dutch Ministry of Social Affairs and Employment (SZW) and the Netherlands National Institute of Public Health and Environment (RIVM) It is evaluated that some Chinese mask standards are equivalent to related European standards.

Among them, KN95 and KP95 (protection level equivalent to FFP2) and KN100 and KP100 (protection level equivalent to FFP3) and the European standard EN 149 in Chinese standard GB 2626-2006 “Respiratory protective equipment-Self-priming filter anti-particulate respirator” 2001 + A1: 2009 “Requirements, inspection and marking of filtering half masks for particle protection of respiratory protective devices” is equivalent. If Chinese KN95 masks enter the Dutch market as medical surgical masks, GB 2626-2006 is equivalent to the Dutch national standard NEN-EN 14683: 2019 “Requirements and Test Methods for Medical Masks”.

In response to the shortage of anti-epidemic materials, the Dutch government coordinated national protection products and mobilized various departments to supervise products without CE marking.

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WTO: 80 countries have banned or restricted the export of medical materials since the outbreak

On the 23rd local time, the World Trade Organization (WTO) issued a report saying that since the outbreak of the New Coronary Pneumonia epidemic, a total of 80 countries have banned or restricted the export of masks, gloves and other medical protective equipment to alleviate the plight of the country’s material shortage.

According to Reuters news on the 24th, the WTO pointed out in its report that the above export ban was promulgated and implemented by 72 WTO member countries and 8 non-member countries, of which only 13 member states fulfilled their notification obligations in accordance with WTO regulations.

The WTO stated that the lack of transparency in restrictive measures and the inability to reach consensus on international cooperation will undermine the efforts of countries to curb the spread of the new coronavirus. As of 12:00 on the 24th, Beijing time, more than 2.72 million people have been infected with the new coronavirus, of which more than 190,000 have died.

“Although we understand that many countries have introduced measures to restrict exports, the decisions of these countries have weakened the possibility of international cooperation, or have exacerbated the situation of countries that are highly dependent on the import of medical supplies, and have triggered supply shortages.” The WTO wrote in the report Tao, “This type of export restrictions not only disrupts the existing supply chain of medical supplies, but may also hinder the supply of supplies in an emergency.”

According to a Reuters article, the WTO has always opposed measures to ban or restrict exports, but it is exempt from special circumstances. For example, the organization allows exporting countries to take temporary measures “to prevent or alleviate serious shortages in key areas such as food.”

The WTO emphasized in the report that due to the epidemic, global travel restrictions have slowed down the flow of goods, and export restrictions have made it more difficult for governments and companies to adjust procurement projects or change suppliers ’plans.

Reuters reported that the leaders of the Group of 20 (G20) had jointly stated in March that all emergency measures adopted by countries in response to the new coronary pneumonia pandemic should be “targeted, appropriate, transparent and temporary.” the rules. However, after the G20 made the above statement, many countries still introduced new export restrictions.

At the same time, despite the European Union’s repeated calls to member states to cancel or cause restrictions on other countries’ material shortages, France has expanded its list of restricted medicines.

The WTO believes that the introduction of new export restrictions in many countries may lead other countries to follow suit, thereby further impacting the global supply chain.


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