Respiratory protective equipment (RPE) and civil masks

The list of respirators approved by the authorities does not exist, as the authorities do not approve respirators. The responsibility for the conformity of the product lies with the companies that sell them.  Manufacturers of respiratory protective equipment are obliged to have the equipment type examined by a notified body, which is not a public authority.

Thus, supervision is carried out as spot-checks. Tukes publishes information on products found to be unsafe.

Respiratory protective equipment is intended to protect the wearer. The FFP classification is derived from standard EN 149 for respirators. The rating indicates the protective effect of the mask. The FFP3 class has the highest protection, the FFP2 class the second highest and the FFP1 class the lowest.

If you intend to place respiratory protective equipment or surgical masks on the market, the authorities can provide you with more information on the legislation related to the products and the preconditions for placing them on the market.

In a pandemic such as the coronavirus, the duties and procedures to be followed are those specified in the National Preparedness Plan for an Influenza Pandemic (Ministry of Social Affairs and Health publication 2012:9) In duties related to public communication, the plan emphasises the role of the Ministry and the Finnish Institute of Occupational Health. Tukes does not issue guidelines or monitor the use of masks or RPE.

Tukes is the market surveillance authority for general consumer goods and personal protective equipment intended for consumers. As a market surveillance authority, Tukes carries out spot checks to ensure the conformity of products and obligates companies to take the necessary measures if their products do not conform to safety requirements. For more information on case handling and market surveillance by Tukes, see the webpage (in Finnish).

Tukes also actively guides and instructs companies in meeting their legal obligations on product safety and ensuring that their products conform to legal requirements. Information on respiratory protective equipment and other masks is available here (in Finnish) For more information on requirements, see the Tukes webpages on PPE, general consumer goods and the CE marking.

There are also RPE products and face masks intended for professional use available on the market, such as companies’ employees and healthcare personnel. The market surveillance of PPE intended for professional use is the responsibility of the Ministry of Social Affairs and Health and regional occupational safety and health authorities. The Finnish Medicines Agency (Fimea) is the competent authority for PPE classified as medical devices.

RPE and face masks are different in the form of protection they offer.

RPE are a type of personal protective equipment that protects the wearer from airborne particles.

Surgical masks are used mainly in healthcare settings, and their purpose is to protect the patient from being infected by healthcare personnel. They do not protect the wearer from airborne pathogens and particles.

For more information, see the Finnish Institute of Occupational Health (TTL) website and the announcement by the Finnish Work Safety Association (in Finnish).

RPE must comply with Personal Protective Equipment Regulation (EU( 2016/425). RPE are classified as category III PPE. The manufacturer must ensure that PPE complies with the relevant health and safety requirements. Respiratory protective equipment sold in Finland must include:

• An EU type-examination certificate (the type examination process is described in detailed on the Tukes website and in the PPE Regulation)
• EU declaration of conformity, in Finnish and Swedish (template in Annex IX of the PPE Regulation)
• user instructions in Finnish and Swedish
• CE marking and identification number of the relevant notified body on the PPE
• manufacturer and product identifier on the PPE.
• technical documentation drawn up by the manufacturer (see Annex III of the PPE Regulation for more information). The manufacturer draws up technical documentation for the type examination.

The CE marking is affixed to the product by the manufacturer or its authorised representative. That's not approval given by authorities. Additional information on the CE marking

The CE marking of the respirator shall be followed by the number of the notified body involved in ensuring the uniformity of production of the product. A notified body other than the EU type-examination may participate in the verification of the uniformity of production. The notified body is not a public authority. The notified bodies can be found from  the Nando database. 

In the EU type examination, a notified body assesses the technical design of the PPE and the conformity of a specimen of the PPE.  The notified body issues an EU type-examination certificate for PPE that conforms to the relevant requirements

Further information

Notified bodies that carry out type examinations are listed on the European Commission NANDO website. In Finland, the notified body for PPE is SGS Fimko Oy.

Respiratory protective equipment must include an EU declaration of conformity. It is a document in which the manufacturer declares that the product conforms to the requirements. Further information

The sale of filtering half-masks for protection against coronavirus for professional use in accordance with the guidelines of the Ministry of Social Affairs and Health has been permitted until 31 May 2021, and filterable half-masks in accordance with the guidelines of the STM may no longer be sold. Further information about the updated policy outline (in Finnish).

The derogated requirements did not apply to personal protective equipment for consumer use which, according to the manufacturer, is intended to protect consumers.

RPE intended for consumer use must include both an EU declaration of conformity and an EU type-examination certificate. The documents must be titled as such. Documents with titles such as ‘Certificate of conformity’ or ‘Certificate of compliance’ are not documents required by the PPE Regulation. The EU type-examination certificate must be issued by a notified body.

Examples of suspicious documents on the European Safety Federation website.

Information about, for example, inappropriate paperwork concerning PPEs or medical devices is available from the TIC Council presentation.

• Check that the document is titled EU Declaration of Conformity.
• Check that the EU declaration of conformity follows the structure in Annex IX of the PPE Regulation.
• Check that the manufacturer’s name and address listed in the EU declaration of conformity are identical to those in the EU type-examination certificate.
• Check that the product named in the EU declaration of conformity (product, type, batch or serial number) is identical to that in the EU type-examination certificate, and that the information matches those found on the product.
• Check that the date of the EU declaration of conformity is on or after the date of issuing the EU type-examination certificate.
• Check that the notified body referred to in the EU declaration of conformity is the same body that issued the EU type-examination certificate.
• Check that the declaration is signed.

• Check that the document is titled EU type-examination certificate.
• Check that the notified body issuing the EU type-examination certificate is listed in the Commission’s NANDO database and that it has the authority to issue type-examination certificates under the PPE Regulation (Legislation: Regulation (EU) 2016/425 Personal protective equipment).
• Check that the product specified in the certificate is identical to the product you are intending to purchase, i.e. the product, type, batch or serial number match the information on the EU type-examination certificate.
• Compare the date of issuing the certificate to your previous communication. If the certificate has been issued recently but you have been in talks over the sale for a longer period, ask for details about the type-examination procedure.
• Check that the certificate has an end date of validity and that the end date is no more than 5 years after the certificate’s date of issue.
• Compare the language used in the certificate to that in the PPE Regulation. Assess the certificate’s overall appearance in terms of typeface, structure and spelling. Official certificates are generally clearly structured and free of spelling errors. Check the certificate’s headers and footers and possible watermarks and compare their images and logos with those found on the notified body’s website.

Unlike masks intended as personal protective equipment (PPE) or medical devices, there are no harmonised European standards on community masks considered as general consumer goods. There are also no national recommendations for community masks in Finland. 

Following a request from the European Commission, the European standardisation organisation CEN has developed a new CEN Workshop Agreement (CWA) on community face coverings, which is also available from the SFS standard webstore.
 

The CWA was drawn up on the basis of the following recommendations known to Tukes:

• France AFNOR SPEC S76-001
• Belgium: NBN/DTD S 65-001:2020
• Spain: UNE 0064-1 Adults single use, UNE 0064-1 Children single use and UNE 0065 Reusable
• Portugal: DQ089_REV02_Reusable Nivel_2_3_Modelo_B and DQ090_REV02_Reusable Nivel_2_3_Modelo_C
• Switzerland: EMPA Recommendations for minimal specifications for civil masks for Swiss manufacturers
• Ireland: SWiFT 19:2020 Barrier masks for consumers - Requirements

If the CWA or recommendations listed above are applied in manufacturing civil masks, the masks must nevertheless comply with the requirements of consumer safety legislation (see previous questions). In particular, care should be taken to ensure that non-certified civil masks are not confused with PPE or medical devices. Tukes does not advocate any of the recommendations listed above but shares them for informational purposes and to be followed where applicable. Ultimately, each company is responsible for ensuring that its product complies with legal requirements.

If CWA or any of the recommendations listed above are applied in manufacturing, this may be stated in the product information, provided that the product does not give the impression that it is a type of PPE or medical device.
 

The warnings and essential safety information required by law must be supplied with civil masks. It is not sufficient to provide this information only in electronic form, such as on the company’s website. Section 4 of the Government Decree on information to be supplied with consumer goods and services (Valtioneuvoston asetus kulutustavaroista ja kuluttajapalveluksista annettavista tiedoista, 613/2004) contains a more detailed definition of information that may be essential for safety.

There are no harmonised European standards on civil masks that are considered general consumer goods, unlike masks intended as personal protective equipment (PPE) or medical devices.

General consumer goods must fulfil the requirements of the Consumer Safety Act and the Decree on information to be supplied.

The technical characteristics of the products and materials must be such that they are in fact suitable for the stated purpose. Among other things, the products must not make breathing too difficult or cause other hazards for special groups, for instance.

Standards targeted at other products, such as PPEs and medical devices, can also be used in the design and manufacturing of general consumer goods as applicable. Due to the coronavirus epidemic, European standardisation organisations are offering these standards for free for the use of the manufacturers.

NB! If the product information or marketing material has any reference, direct or indirect, to  standards regarding personal protective equipment or medical device:

- the product can no longer be considered general consumer goods

- the product must also fulfil the other requirements of the Personal Protective Equipment Regulation or the legislation on medical devices.

With regard to the materials used, guidelines can be found, as applicable, from sources such as the commission’s interpretations, see the answer provided for the last question Q8. 

Further information on making cloth masks can be found in the joint press release by Tukes, Fimea and Finnish Institute of Occupational Health (TTL).

If you sell civil masks such as cloth masks  to consumers, please note at least the following issues. These issues apply to masks that have not been placed on the market as PPE or medical devices.

– Civil masks such as cloth face masks sold to consumers must fulfil the requirements of the Consumer Safety Act (920/2011) and the Government Decree on information to be supplied in respect of consumer products and services (613/2004). All information about civil masks essential considering safety must be provided clearly and understandably for consumers, both in Finnish and in Swedish. This information must be provided with the product and so that consumers can obtain the information required before making any purchase decision.

– The purpose of use of the product must be presented clearly, such as reducing the spread of droplets into the environment. Presenting a purpose of use that is not the actual purpose cannot be used to circumvent existing legislation.

– The product’s operating instructions must have the necessary information on the safe use of the product, such as to whom the mask is or is not suitable, how to put it on safely, how to change it, what factors affect the protection, washing instructions, etc. According to current knowledge, it must be possible to wash civil masks at 60 °C at minimum. The company is responsible for ensuring that the use of the mask is safe and hygienic with the washing instructions given.

– The product information must highlight that the product is not a PPE and that if users need to protect themselves from the virus, they also need to acquire respiratory protective equipment suitable for the purpose.

– If the product is not a PPE, it must not have references to personal protection standards of protection classes such as FFP2 or EN 149, or any other kind of misleading information on protection.

– Providing conflicting information on the product or images that could give users the impression that the product protects its user is prohibited. If the product information given or the marketing material can give the impression that the product can be used as a PPE, it must fulfil the requirements set for personal protective equipment. This also applies to references to use for medical purposes (such as surgical masks and the use of terms such as “surgical” and “medical”).

– If the product’s exhalation filtration efficiency (%) has been tested (e.g. in accordance with the CWA specification), it can be indicated in product information. However, the product information cannot indicate that the product protects its user. If any specification or other recommendation applicable to civil masks is used in manufacturing, this can be indicated in product information, provided that the product does not give the impression that it is a type of PPE or medical device.

– If the mask is marketed as possessing antibacterial or other biocidal properties or to have been manufactured from an antibacterial material, see section “Requirements for chemicals”.

 – General consumer goods cannot have a CE mark, even if the product standards of personal protective equipment or medical devices had been used in designing and manufacturing the general consumer goods as applicable.

See also the instructions by Tukes on information provided on general consumer goods (in Finnish).

The REACH Regulation also applies to chemical substance in articles. Consequently, respiratory protective equipment and cloth masks must conform to the requirements of REACH. In the case of RPE and civil masks, particular attention must be given to restricted substances and substances of very high concern. For more information on these, see the Tukes webpage (in Finnish).

For more information on the REACH Regulation, see the Tukes website.

If the mask is marketed as possessing antibacterial or other biocidal properties or manufactured from an antibacterial material, the product is claimed to have a biocidal function. If the mask has been treated with a substance intended as a chemical deterrent to organisms such as bacteria, the requirements of the EU biocidal products regulation (528/2012) must be observed. According to the requirements, the labelling for products treated with biocidal substances must indicate the active substance used to achieve the product’s biocidal function.

The active substance must be approved in the EU or included in the EU risk assessment program for biocidal active substances in the applicable product-type. Description of product-types on the ECHA website.

For more information on biocidal products and treated objects, see the Tukes website.

Respiratory protective equipment or other masks are not covered by price regulation. The authorities do not have power to intervene in practices that consumers may consider price gouging. Consumer protection legislation is enforced normally during the coronavirus crisis. See the announcement by the Finnish Competition and Consumer Authority.

Misleading marketing is prohibited by the Consumer Protection Act. Claims or implications made concerning a product must be factually correct. The Finnish Competition and Consumer Authority supervises compliance with the Consumer Protection Act and has made an announcement on scams and misleading marketing during the coronavirus crisis.

At worst, inaccurate or misleading claims made on respiratory protective equipment may endanger the user’s health. Users may not be given an unfounded sense of security, and the information provided on the product must be sufficient to allow buyers to select the correct product for the intended use. Authorities that monitor PPE may take up the issue if misleading marketing claims pose a hazard to users. In Finland, there are several competent authorities on respiratory protective equipment and surgical masks:

• The competent authority for PPE intended for professional use are the Ministry of Social Affairs and Health and regional occupational safety and health authorities.
• Fimea is the competent authority for medical devices, such as surgical masks.
• Tukes is the competent authority for general consumer goods and PPE intended for consumer use. Only those respiratory protective equipment which are expressly stated to be intended for consumer use are considered appropriate for consumers. If a respiratory protective equipment’s intended user group is not specified, the product is considered to be intended for professional use.