Issued on 28 Apr 20
The Ministry of Industry, Commerce and Tourism is the competent Department for the proposal and execution of the Government's policy regarding industry.
Specifically, the General Secretariat for Industry and Small and Medium-sized Enterprises is responsible for preparing and proposing regulatory provisions for the management of industrial activities and infrastructure for industrial quality and safety, and within it and through the General Directorate of Industry and SMEs the preparation and monitoring of regulatory provisions in the field of quality and industrial safety on industrial products and facilities provided for in Law 21/1992, of July 16, all in accordance with the provisions of the Royal Decree 998/2018, of August 3, which develops the basic organic structure of the Ministry of Industry, Commerce and Tourism.
Given the situation of shortage of PPE with the CE regulatory mark on the national market and the need for them for protection against COVID-19.
As a result of joint work with the National Institute for Occupational Safety and Health (INSST) in order to be able to make decisions about alternatives to European CE marked EPI masks, I resolve:
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Based on the exceptional situation, establish four scenarios for the acceptance of these teams:
1. CE marking with harmonized standard. Standard situation.
2. Public purchase without CE marking of PPE masks that meet the specifications indicated below, with prior authorization from Health. In this case, these PPE masks can only be supplied to healthcare personnel.
3. Temporary exception to accept the commercialization of protection masks without CE marking that meet the specifications indicated below, after analysis by the Health authority as Delegated Authority or by an Autonomous Community as authority for Market Surveillance on a temporary basis while carrying out the procedures necessary to affix the CE marking. The authorities mentioned must verify that the product has the documents that guarantee that the product meets the specifications indicated below and that there is an evaluation request sent to a notified body.
The notified Spanish organizations will send weekly to the Ministry of Industry, Commerce and Tourism a list of requests received in these circumstances and the status of the evaluation.
4. CE marking with a different technical specification than the harmonized standards. The Ministry of Industry, Tourism and Commerce will notify the notified Spanish bodies that, having analyzed the specifications cited below and given the exceptional situation, they will be considered to offer an adequate level of health and safety in accordance with the essential health and safety requirements established in the Regulations ( EU) 2016/425 in order to obtain a CE marking and that may make use of the reports of total or partial tests available to the product.
Accept the following NIOSH and Chinese specifications, with the detail and requirements specified below.
The certification process for N95 masks considering the differences in both the parameters of the filtration tests and the test agents used, in the case of biological protection in which the presence of oil-based bioaerosols is not expected, can for the purposes of this resolution, equivalent to the European ones as indicated in the following table.
EU certificationNIOSH certificationFFP2N95, R95, P95FFP3N99, R99, P99, N100, R100, P100
A "Surgical N95" mask would be comparable to a dual-use mask (EPI + PS).
In this case, you have the advantage that a list can be accessed from the following CDC link: https://www.cdc.gov/niosh/npptl/topics/respirators/cel/default.html.
This list allows you to check if a mask is NIOSH certified, which can be useful.
The GB2626 standard in principle is applied by the manufacturer itself in a self-certification process under his own responsibility and the market surveillance is what works in his case.
Due to the coronavirus crisis, the Chinese Government ordered that all masks be verified in three aspects: penetration efficiency, resistance to breathing and marking. Consequently, all masks on the Chinese market should have test reports with these three results, carried out by the National Quality supervision and testing center for personal protective equipment . Each province has at least one of these laboratories that are accredited.
The measures established in this resolution will be applicable only for the duration of the exceptional situation for which they are the cause.