Antiviral masksCtgb received the question whether antiviral respirator masks are biocidal products or not.
These masks are made of different layers, one of them being a coating with citric acid. They are used mainly by people working in hospitals to prevent the infection with viruses.
Especially nowadays with the Mexican flu the use of such masks are recommended.
Because of this layer of citric acid this mask is more effective against viruses then masks without citric acid. The firm compared the viral log reduction from the outside to the inside of masks without citric acid (log 4.5), with masks containing this active (> log 6.67). From this information it is clear that the citric acid in this form and product kills viruses.
It is also clear that the citric acid is applied to protect humans against different kind of micro-organisms including viruses.
Therefore our conclusion would be that these masks are biocides in PT1.
However, the firm now has removed all biocidal claims and wishes to market these masks as “Actiprotect respirator FFP2 masks with virucoat technology”. FFP2 masks have an 95% efficiency. Moreover, this type of mask without biocidal actives, is commonly used.
To our opinion the citric acid coated mask is still a biocide. Although there is no clear claim it still is: a preparation containing an active substance, put up in the form in which it is supplied to the user, intended to destroy a harmful organism by chemical means.
Some investigation showed that this kind of masks are also marketed with other active substances, for instance particles of silver, copper, zinc, iodine, etc. This suggests that there are far more types of masks that candidate for being a biocide.
Ctgb would like to receive your comments on the subsequent propositions:
A respirator mask with citric acid or other active substances, used to protect humans against micro organisms by chemical means is a biocide.
When it is clear that, when an active substance is added to a mask to bring about a biocidal effect, such a mask, although without biocidal claim and by itself already used for protecting humans, is a biocide that needs authorisation
Ctgb received reactions from FI, UK, EE, SE. CY, PT, NO, EL, LT and COM. For the full text of their reactions, see the following pages. In short:
FI agreed with Ctgb, with reference to Council Dir. 89/686/EEC relating to personal protective equipments. We have also confirmed from the Finnish authority of Medicines that antiviral masks are not in the scope of legislation concerning medical devices.
UK agreed as well, and mentioned entry 2.5.1.1 on impregnated tissues.
EE, SE, CY, PT, NO, EL, LT agreed to some extent;
COM discussed the case with colleagues from DG Entr: “we share the Swedish view on the distinction between medical devices and personal protective equipment (PPE). This distinction is highly relevant for our work, since Article 1(2)(h) of the Biocidal Products Directive explicitly excludes any product - even if complying with the definition of biocidal products in Article 2(1)(a) of the Biocidal Products Directive - that is covered by the Medical devices directive 93/42/EEC [...] Our conclusion is that anti viral masks intended, at least partially, for protection of patients rather than protection of the wearer of the mask will not require authorisation as a biocide, but have to comply with the requirements of the Medical devices directive.”
Conclusion: Ctgb proposes that anti viral mask are excluded from the BPD, and fall under the medical Devices Directive, since it cannot be determined beforehand who will wear such a mask and for what purpose: it can be used both by surgeons and nurses to protect the patient, and by the man in the street to protect himself, for instance against the flu.
Full text of reactions by member states and Commission
FI
thank you for raising this question! We have also received the same question and are very interested in getting the views from other MS to this question.
We agree with you that treatment of masks with citric acid with intention to get an antiviral effect is biocidal use of this substance in PT 1. However, whether we should authorise a treated mask or only a product/substance used for the antiviral treatment, it is not clear for us. In fact, we don't except that any company would apply for an authorisation to citric acid for the antiviral treatment of masks. Hence, the first placing on the market of citric acid for the antiviral purpose would be as a part of the article (=mask).
We tend to agree with NL that a mask treated with citric acid or other active substances, used to protect humans against micro organisms by chemical means is a biocidal product and has to be authorised. AS well, the treated product should be considered as a biocidal product when an active substance is added to a mask to bring about a biocidal effect, regardless the product is with or without a biocidal claim.
In addition it has to be taken into account the Council Dir. 89/686/EEC relating to personal protective equipments. We have also confirmed from the Finnish authority of Medicines that antiviral masks are not in the scope of legislation concerning medical devices.
UK
The UK agrees with the position put forward by the Netherlands and Finland that the mask should fall into PT1, and we also considered entry 2.5.1.1 in the Manual of Decisions, where Member States decided that a tissue impregnated with an anti-viral biocide should be considered to be PT1 which has some similarities to an impregnated face mask.
We also agree that if the intention of adding the citric acid is to give a biocidal effect, then even if no specific claims are made, the product should be considered to be a biocidal product.
On the issue of what should be considered to be the biocidal product itself - the impregnated mask or the formulation used to impregnate the mask - we are aware our Swedish colleagues have strong opinions on this kind of question and we trust it will be raised for full discussion as part of the review of the Directive over the next few months, and hopefully we can reach a position all MS can agree to.
EE
Estonia position is that a respirator mask with citric acid or other active substances, used to protect humans against micro organisms by chemical means is a biocide in PT1.
We also support Ctgb proposition that when an active substance is added to a mask to bring about a biocidal effect, such a mask, although without biocidal claim and by itself already used for protecting humans against micro organisms by chemical means, is a biocide and needs authorisation.
ES
According to the Swedish Medical Agency the use of the anti-viral mask determines if it should be regarded as medical device or as personal protection equipment. For instance, if the mask is used mainly to protect the patients in a hospital, it is a medical device and if it is used mainly to protect the one wearing the mask, it is a personal protection device.
If the respirator mask in question is not a medical device, it is still not clear whether it is the active substance (citric acid) or the mask that is the biocidal product that needs authorization.
If the primary function of the mask is not biocidal, Sweden is of the opinion that the citric acid used to coat the mask is the biocidal product that needs to be authorized. So if the primary function of the mask is to protect the user from particles, then the citric acid is the biocidal product.
However, if the primary function of the mask is biocidal (in this case to protect humans against micro organisms by chemical means), then Sweden agrees that the respirator mask with citric acid is a biocidal product.
CY
The Cyprus CA fully agrees with the approach of the NL on this subject.
NO
We were in dialogue with industry earlier this year concerning a very similar product. After som internal discussion including a consultation of the Manual of Decisions, chapter 3, we came to the same views as presented here in several other MS' responses to the question from the NL, that such masks should be regarded as PT 1 biocidal products. We also came to the same conclusion as FI, that the mask is personal protective equipment and therefore not within the scope of the medical devices legislation.
The removal of the claim was not an issue in our dialogue with the industry, but we are inclined to agree that if it is clear that the citric acid was added in order to have an external biocidal effect, the product should be regarded as a biocidal product even if no claims are stated on the label. We doubt that it is a good idea to give a possibility of only changing the label claim in order to avoid authorisation as a biocidal product. As we see it, it is not a desirable situation to have products on the market which have intended external biocidal effects but are not regulated as biocidal products.
PT
Taking this last opportunity, we want to support the position of N and previous MS: we consider a mask impregnated with citric acid to be a PT1 if this active substance is to be released from the product having an external biocidal effect. Also we advise the companies not to label it as a medical device but as PPE.
EL
The Greek CA agrees with the approach of the NL and Cyprus, on the subject concerning antiviral respirator masks.
LT
we received application to authorise respiratory mask, impregnated with biocidal active substance, as PT 1 biocidal product.
Mask is dry.
No contact of active substance with skin, mouth or hair during mask use.
Manufacturer claims and efficacy tests show that it kills different viruses in inspirable air.
Only one place where we can find the formal definition of PT 1 is point 2.1.2.4 of Manual of Decisions: "...disinfectants for skin, scalps and mucous membranes of the oral cavity...". Mentioned respiratory masks are clearly out, we refused authorisation as PT 1.
In the definition of PT 2 (Annex V of Directive 98/8/EC) disinfection of air is mentioned. But, according to our understanding, the meaning here is disinfection of air indoors (performed by professionals), not of air inspired by separate person (done himself).
Proposal:
To amend Manual of Decisions by following or similar: "PT 1 - Human hygiene biocidal products: disinfectants for skin, scalps, mucous membranes of the oral cavity and inspirable air".
Arguments:
There is biocidal action (killing of harmful microorganisms).
Action is by chemical means.
There is no PT to allocate this kind of products at the moment.
Disinfection of inspirable air is in principle similar to other kinds of "personal disinfection" in PT 1: disinfection of person's skin, hair, mouth.
Another possible way is to agree that respiratory masks, impregnated with biocidal active substances, are out of scope of BPD.
COM
Having discussed this issue with our colleagues in DG ENTR, we share the Swedish view on the distinction between medical devices and personal protective equipment (PPE). This distinction is highly relevant for our work, since Article 1(2)(h) of the Biocidal Products Directive explicitly excludes any product - even if complying with the definition of biocidal products in Article 2(1)(a) of the Biocidal Products Directive - that is covered by the Medical devices directive 93/42/EEC.
The recently published guidelines on the application of the PPE directive 89/686/EEC (published on
http://ec.europa.eu/enterprise/mechan_e ... elines.pdf) explain the scope of the PPE directive as follows:
"Equipment used to protect people other than the wearer, such as masks used to protect hospital patients, are not PPE. Nevertheless all equipment worn by health care personnel to protect themselves are PPE."
Concerning the borderline between the PPE directive and the Medical devices directive, the following guidance is given in the same document:
"In order to decide whether the PPE Directive or the Medical Devices Directive should apply, the principal intended purpose of the device must be considered. For example, a mask to be used by a surgeon is a medical device as it protects the patient. On the other hand equipment worn by health care personnel to protect themselves against infectious agents falls under the PPE Directive."
As of 21 March 2010, the Medical devices directive will contain the following provision for dual use products (Article 1(6); amendment introduced by Directive 2007/47/EC):
"Where a device is intended by the manufacturer to be used in accordance with both the provisions on personal protective equipment in [the PPE directive] and [the Medical device directive], the relevant basic health and safety requirements of [the PPE directive] shall also be fulfilled"
This new provision is explained in the abovementioned guidelines as follows:
"The consequence of this amendment is that dual use products (MD and PPE) are covered by [the Medical device directive]. This amendment to [the Medical device directive] allows manufacturers to submit their medical device, intended for dual use to a conformity assessment procedure under [the Medical device directive], which, as the product is also PPE, must include the relevant basic health and safety requirements of the PPE Directive."
Our conclusion is that anti viral masks intended, at least partially, for protection of patients rather than protection of the wearer of the mask will not require authorisation as a biocide, but have to comply with the requirements of the Medical devices directive.
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