ANPC made a truly shocking announcement today, saying that it has removed from sale several tens of millions of non-compliant masks that were sold in Romania, and below you can find the entire press release.
"The National Authority for Consumer Protection (ANPC) has been supervising the market of protective materials since the beginning of the state of emergency and alert caused by the COVID-19 pandemic. Thus, only in the last week, 504 economic operators were controlled, at the level of the entire country, and deviations were found in 275 of them. Masks worth 3,65 million lei were checked, deviations were found in personal protective equipment (PPE), worth 2,1 million lei, (approximately 58%)", reports ANPC.
As a result of the detected irregularities, the ANPC commissioners ordered the application of 382 sanctions, of which 114 warnings and 268 contravention fines, in the amount of 1,75 million lei for violating consumer protection regulations. Complementary measures were added to these, consisting of the temporary stop from the sale of more than 31 million masks and the definitive stop from the sale of more than 90.000 masks.
Deviations found by ANPC
- Total or partial lack of information-characterization elements on the product label
- Lack of registration of instructions for use
- Lack of mention of the composition of the material used
- Lack of translation into Romanian of the information and instructions on the product labels.
- Lack of indication of identification and characterization elements, regarding the name of the manufacturer/importer/distributor and the address of the headquarters in Romania
- Lack of CE marking
- Lack of declaration of conformity
- Lack of indications regarding the special storage and/or handling conditions and/or failure to comply with them
- Lack of information on how to maintain PPE
- Lack of batch or serial number or other element that allows identification of the mask-PPE
- Lack of entry of mask size - PPE
- Marketing of unsafe products (inside the box, the masks were not packed)
- Elements that may mislead the consumer regarding the legality of the product:
- in the declaration of conformity it was written that the mask product was a medical device, and the test report was issued for an PPE subject to another legal framework
- application of the CE marking by non-accredited bodies
- the application of the CE marking to the products "washable hygienic masks" and "washable hygienic masks for children" where it is stated by labeling that "they are not part of the group of personal protective equipment nor of the group of medical devices" on the declaration of conformity, indicating Law no. .245/2004;
- inconsistency between the name of the product and the information on the packaging and those in the declaration of conformity issued by the manufacturer
- instructions for use different from those listed in the technical data sheet, the product being presented as a type II medical device, although the documentation mentions type I. The product had the CE mark without the manufacturer being able to present a document issued by a conformity assessment body
- Unfair business practices
- Lack of display or non-compliant display of prices.
As part of the control actions, the RAPEX notifications of the member states regarding masks were also taken into account. In this context, products notified through the RAPEX system were found on the market, and they were definitively stopped from the market."
