CCPC Guidance for Business re COVID-19 Face Masks
May 26, 2020
This guidance will be helpful to any business who intends to produce or distribute Barrier Masks for consumer use.
There are different types of face masks used in different contexts in connection with the current COVID-19 outbreak. These products have fundamentally different intended purposes and are regulated under different product safety regimes and agencies in Ireland.
The purpose of this guidance is to help business understand the distinctions between these face masks and allow them to ensure that they are compliant with the product safety laws which are enforced by the Competition and Consumer Protection Commission (CCPC).
|Face Mask Type||Barrier Masks||PPE face masks||Medical Face Masks|
|Also known as||Textile masks, comfort mask, community masks, face covering||Respirators; Respiratory Protection Mask; Filtering face mask.||Surgical Face Masks|
|Intended purpose||To reduce the risk of spread of infection in the community||Personal protection from hazardous substances for the wearer||A barrier to minimise the direct transmission of infective agents from staff to patients during surgical procedures and other medical settings with similar requirements.|
|Regulatory Regime||General Product Safety Directive||Personal Protection Equipment Regulation||Medical Devices Directive (currently transitioning to the Medical Devices Regulation)|
|Relevant Authority||CCPC||CCPC (PPE for consumer use)
Health and Safety Authority (PPE for workplace use)
|Health Products Regulatory Authority (HPRA)|
Medical / Surgical face masks are regulated by HPRA as the competent authority for medical devices and further information regarding the HPRA’s approach to the regulation of medical / surgical face masks can be found on HPRA’s website here.
What are Barrier Masks?
Barrier Masks are a type of face covering for consumers. When used in conjunction with relevant public health advice, a barrier mask may help prevent the spread of viral infection to others. Barrier Masks are not intended to protect the wearer against viral infection.
Barrier Masks are not personal protective equipment which are intended to protect the wearer nor are they medical / surgical face masks which are intended to be used in a medical setting.
What are the requirements for Barrier Masks?
Barrier Masks, which are provided to consumers in the course of commercial activity, whether free or at a cost to the consumer, may fall within the General Product Safety Directive (GPSD) and the Irish General Product Safety Regulations (SI 199 of 2004). Producers and distributors of Barrier Masks have various duties under GPSD and SI 199 of 2004.
In Ireland, there is a specification for Barrier Masks known as the SWIFT 19 Specification which has been developed by National Standards Authority of Ireland at the request of the CCPC. CEN, the the European Committee for Standardization also developed a new CEN Workshop Agreement on face coverings. The SWIFT 19 Specification and/or the CEN Workshop Agreement can be used by a producer of Barrier Masks to enable them to demonstrate conformity (pursuant to Regulation 5 (3) (b) of S.I. 199 of 2004) with the general safety requirements of S.I. 199 of 2004.
The SWIFT 19 Specification specifies the minimum requirements for the design, manufacture, performance, packaging, marking and information for use, for Barrier Masks intended for single use or reusable use for consumers to reduce the risk of general transmission of a viral infection. The SWIFT 19 Specification includes testing methods for performance requirements specified for the Barrier Masks.
At this time, there are no harmonized European standard for Barrier Masks for general consumer use, unlike masks for personal protective equipment or medical devices.
Barrier Masks must not be sold as either personal protective equipment or medical devices. Products which do not comply with the requirements for personal protective equipment or medical devices must not give consumers a false impression that they are personal protective equipment or medical device. Therefore, product information for Barrier Masks must not contain references to personal protection equipment standards or classifications such as FFP2, EN 149, KN95, or N95. Barrier Masks must not contain claims that they protect, or are intended to protect, the wearer from viruses such as COVID-19. Such claims would be considered criminal offences under consumer protection and product safety law.
In line with the SWIFT 19 Specification:
- Markings: Barrier Masks should be clearly and durably marked with the information below on the smallest marketable package available:
- The Barrier Mask should include the wording “Barrier Mask”.
- The name and address of the producer.
- Indication of whether product is for single use or reusable.
- Any warnings;
- Any other requirements in the SWIFT 19 Specification.
- Instructions for Use: Barrier Masks should be supplied with an instruction/user guide which shall be in English and include necessary information on:
- any warnings or information;
- cleaning of Barrier Mask;
- safe use of the Barrier Mask;
- how to fit, use, put on and remove the Barrier Mask.
- Warnings and Information: The Barrier Masks should contain the following warnings on both the package and the product information:
- Warning: This Barrier Mask is not intended to protect the consumer against viral infection. Used in conjunction with relevant public health advice, a Barrier Mask may help prevent the spread of viral infection to others.
- Warning or Warning Symbol: Indicating that this Barrier Mask is not suitable for children under the age of three.
- Warning: Children should be supervised at all times.
- This is not personal protective equipment or a medical device under EU law.
- CE Marking: Barrier Masks, as GPSD products, must not bear the CE Marking.
- Testing: The producer is required to conduct verification and validation tests within its facility or in collaboration with a test laboratory that has the appropriate means of testing before placing any Barrier Mask on the market.
This is not an exhaustive list of the specifications in the SWIFT 19 Specification and all producers should consult the full text of the SWIFT 19 Specification.
Who is the competent authority for Barrier Masks?
The CCPC is the competent authority for all products within the scope of GPSD.
A product in GPSD is defined as “any product, including in the context of providing a service, which is intended for consumers or likely, under reasonably foreseeable conditions, to be used by consumers even if not intended for them, and is supplied or made available, whether for consideration or not, in the course of a commercial activity and whether new, used or reconditioned.”
Barrier Masks when made available to consumers in the course of commercial activity (i.e. by a retailer to its customers), whether for free or at a cost to the consumer, will be considered within the scope of GPSD.
What are PPE Face masks?
PPE Face masks, also known as respirators, are intended to protect the wearer of the PPE face mask from particles, droplets and aerosols.
What are the requirements for PPE face masks?
The PPE Regulations set out the essential requirements which must be met before personal protective equipment (PPE) products, including PPE face masks, can be placed on the Irish market. Further information about the requirements for PPE products, including PPE face masks, can be found here.
All PPE within the scope of the PPE Regulations must undergo a conformity assessment procedure, in accordance with its risk categorisation, to demonstrate compliance with the essential health and safety requirements (listed in Annex II of Regulation (EU) 2016/425 or Schedule 2 of the PPE Regulations).
Unlike Barrier Masks, PPE Face masks must be marked with a CE mark when in conformity with Regulation (EU) 2016/425.
In response to the crisis, the European Commission has published Recommendation (EU) 2020/403 on conformity assessment and market surveillance procedures to ensure that, in the context of COVID-19, availability of PPE matches demand, whilst continuing to provide an adequate level of protection of the users’ health and safety. Further information about this Recommendation can be found on the CCPC’s website here.
Who is the competent authority for PPE Face Masks?
The CCPC and the Health and Safety Authority (HSA) are the designated Market Surveillance Authorities (MSA) in Ireland for the purposes of Regulation (EU) 2016/425.
The CCPC is responsible for the market surveillance of PPE for consumer use. The HSA is responsible for the market surveillance of PPE for workplace use. Further information relating to workplace PPE in response to COVID-19 is available on the HSA web site here.
Businesses with queries regarding the regulatory requirements of Barrier Masks or PPE Face masks for consumer use should contact us at firstname.lastname@example.org
Information will be updated as necessary.Return to News