BSIF have provided the answers to the questions asked in good faith and to the best of our ability. BSIF cannot be held legally liable for the answers provided.
Question: If we advertise the masks as non medical social masks for use in the community do they count as ppe?
At this moment in time we should wait for guidance from UK Government as to whether Masks will be required for non work related activities and to what specification will be required.
Question: Is it possible for a product to be both a medical device, to protect a third party from the wearer/user of the device, and an item of PPE, to protect the wearer from an external risk? Can you please provide examples where this might occur?
MD and PPE for 1 product are possible and thus also the marking with the standards linked to the different legislation (of course provided that the product fully complies with the standard mentioned). The DoC has to include all legislation or can be 2 separate DoCs (one for each legislation), but then they must always be made available together.
Question: 1. Is it mandatory for an Importer the identification of an authorized representative if the imported product is extra EU? 2. Can the FFP1 type facial filter belong to categories other than III? 3. Are there preparatory tests for EN149 for subsequent tests? There must necessarily be a precise order in carrying out the tests or Is it possible to test some clauses first and then integrate with the missing ones? 4. For facial filters, is there a technique (FMEA, FTA …) that is preferable to follow regarding risk analysis? Among the harmonized standards according to EU Reg. 2016/425 there is no specific indication that offers a reference tool. 5.What does carrying out tests at non-accredited laboratories mean for the purpose of conformity assessment by an ON? Do tests need to be repeated or do additions need to be done? In the latter case, what kind?
1.Only Manufacturers may appoint Authorised Representatives in line with the PPE Regultaion requirements, this is a choice by the manufacturer rather than a requirement. 2. No, All RPE (Respiratory Protective Equipment) is Category III as nay respiratory hazard is deemed IDLH – immediately damaging to life or Health. 3. EN 149:2001+A1:2009 details all the testing and pre-conditioning requirements for the testing of RPE. 4. Matching protection to the hazard is key, and the relevant EN Standards detail which types of filtration method are suitable for which type of hazard. 5. Tests from Non-Accredited Laboratories will usually not be accepted and test results from approved labs will be requested. Currently they may be accepted as part of the (EU) 2020/403 process relating to PPE for protection against the Covid19 virus.
Question: If sell masks in the uk for use in the usa, does it still have to conform to uk standards?
If the Mask is being sold to a customer in the UK for onward shipping to the USA, then it will need to conform with the relevant requirements for both countries, if it is being sold directly to a customer in the USA then it needs to comply with relevant US requirements.
Question: Does the panel think that there should be a online portal for sale of all PPE, where all checks have already been put in place and companies can rest easy that they are receiving compliant product. I have read so much about N95 masks not being used in EU/UK but then other information provided advises they are acceptable there seems to be alot of contradicting information.
There is much information in the marketplace about comparison between various RPE (Respiratory Protective Equipment) from around the World. At this moment in time, unless a product has been assessed and certified by a Notified Body either to the PPE Regulation or by a Notified Body or the Cross Government Committee as part of the (EU) 2020/403 process relating to PPE for protection against the Covid19 virus.
Question: Should purchasers be wary of companies who don’t normally supply PPE given that their knowledge of products and associated standards is likely to not be as strong as companies that have always supplied product?
Yes of course. PPE is a highly regulated market for good reason these are life preserving products. People in the supply chain have legal “obligations and responsibilities” and inexperienced traders will be ignorant of these.
Question: Would the need for certification apply to an organisation that wished to manufacture masks for distribution to its staff or students if these were Category 1 products?
RPE (Respiratory Protective Equipment) is always Category III PPE and assessment/certification is required whomever the end user may be.
Question: Some say that Catagory I does not exist. From what has been said it does. Can you Help?
Category I – Simple Risk does exist, it is listed in the PPE Regulation and was covered in the Webinar. There may be some confusion with Class 1 from the Medical Devices Directive, which is spearate legislation to the PPE Regulation.
Question: Many schools and colleges are producing PPE to donate and help care homes etc. Where do these stand within the regs?
They still have to comply with OPSS Guidance (available on the BSIF website).
Question: Are there any face masks/coverings that DON’T need DoC and certification?
So called civil / comfort mask are not regulated at the present moment.
Question: Comparison chart for face mask types and the certification required?
As a comprehensive chart across all RPE this is not yet available.
Question: I work in the construction industry – employers are looking to upgrade RPE – is there a way to facefit safely?
You should follow HSE guidance available at www.hse.gov.uk
Question: There are some online PPE exchange platforms that have appeared whereby suppliers are matched with those requiring product. What responsibilities do the exchange platforms have under the legislation?
The same obligations will exist for this type of platform as for any other Economic Operator involved in the UK/EU Supply Chain.
Question: Does Covid-19 fall into the category 3? immediate hazard to life?
Yes it would be a respiratory hazard.
Question: In NZ we have seen a huge influx of over the ear loop style ‘P2 masks’. Is an over the ear loop style acceptable under the CE standard? (as a side note we find the quality is very poor and the rate of fit test failure is up to 100% on many of the samples we have fit tested).
EN 149 does not specifically exclude “ear loops”. This style was unknown in RPE in the UK prior to the pandemic and the ensuing shortages. We share your concerns about the ability of these products to face fit effectively, and if they do not face fit effectively safety is compromised.
Question: I come from a height safety sector. Is anything being done by BSiF to address issues of accessing PPE via on-line “marketplaces” such as Amazon? Is anyone dealing directly and face-to-face with Amazon?
We are dealing with Amazon through our and their Trading Standards Primary Authority partnerships. We appreciate the scale of the problem and are proactively working on the issue.
Question: Not really a CE question but if an employer cannot source FFP3 respirators for welding operations, can they substitute with FFP2 which they have stocks of?
While appreciating the problem you cannot provide PPE that is inadequate. You must follow HSE guidance available at www.hse.gov.uk
Question: We have received an offer of a “snood” purporting to be “Virustatic Shield” antiviral snoods. The claim is that the snood has been developed to reduce pathogenic microbial intake into the human respiratory system. The fabric apparently incorporates an antiviral coating laboratory tested to neutralise 96% of airborne viruses and reduce the risk of cross-contamination. I feel this is setting itself up as an item of PPE with no testing or certification – any thoughts?
It is our belief that products which make specific claims must be challenged to evidence these claims. We will see an increase in these types of product on the market and the authorities must address the issue.
Question: Hi There. As a Local Authority we have a large amount of RPE that we have not been able to verify, in this event how can we assure ourselves the RPE performs as hoped. We have asked the HSL to assist with verification without success.
It is difficult to say without further information – if you would like to send any supporting documents and images of the RPE (showing any markings) to our enquiries email address we will see if we can assist further – firstname.lastname@example.org