In view of the surge in demand for face masks because of the Covid-19 pandemic, the Labour Inspection Department issued guidelines on Wednesday.
It said the guidelines were intended for suppliers and aimed to protect consumers and to inform those who supply them either as volunteers or as a business.
There are two kinds of respiratory protective devices, it said, those used by medical professionals (photo 1) and those offered for individual protection like filter masks (photo 2).
The announcement does not cover all types of face masks, it said, but only those in increased demand because of the Coronavirus pandemic (pictured below).
Medical face mask based on the European standard ΕΝ 14683.
Protective filter masks based on the European standard ΕΝ 149. The exhalation valve facilitates exhalation and is not obligatory.
The competent authority for the medical equipment is the Health Ministry’s Medical and Public Health Services, the announcement said, and health professionals “have received relevant instructions and should be aware of the type of equipment they should use in each case.”
Face masks with a filter are used for individual protection. This means that the manufacturer puts together a technical file, follows specific standards, accompanies the product with a manual, addresses a Notified Body to obtain certification for the products and affixes the CE marking with their name and the name of the importer / distributor. They also need to refer to the ΕΝ 149 standard applied in the manufacturing, trial and checks.
The Labour Inspection Department voiced concerns over a recent surge in social media of volunteer groups manufacturing masks for hospitals and other front line services.
“Although we are aware that volunteers mean well, we should emphasise that people can’t go around making protective gear of questionable standards without a certified level of protection and quality,” the Department said.
It added that filter masks constitute personal protective equipment with a specific level of protection per case that should be certified by a Notified Body.
In addition, it raises alarm on certain online ads that appear on an array of websites promoting pieces of fabric as “protective masks”. “These masks are of questionable protection levels and quality,” it said.
The Department “warns those who make or sell masks with filter without the necessary CE marking that they are putting consumers in danger and are in violation of the law.”
It said that protective masks with a filter constitute personal protective equipment, should bear a CE marking and an instruction manual and be manufactured in accordance with the European regulation (ΕΕ) 2016/425 on personal protective equipment.
In conclusion, the announcement said that interested parties (importers, distributors, suppliers) can contact the Labour Inspector Socratis Socratous on the numbers 25827204 or 25827200 for information and queries.
1. There is an array of respiratory protective devices that includes masks (half masks or full face masks) that are not dependent on the external environment and masks (half or full) with a filter that filter the external air breathed in. Respiratory protective masks under the EN149 standard are half masks that filter the external inhaled air with a filter that protects against particles. They are classified into three types according to their filtering capacities (FFP1, FFP2, and FFP3 at the top level of protection)
2. Before using respiratory protective devices in the workplace, a risk assessment is undertaken to define the type of equipment to be used depending on the exposure to the damaging element and the damage it can cause to someone’s health. After choosing the right type of respiratory protective device, there is training and supervision of the staff that uses it (e.g. correct application on nose, mask to cover mouth and nose, no beard on face)
3. A Notified Body is an accredited supervisory body approved by the competent Member-State and the European Commission acting in an independent capacity.