What has been the impact of Regulation (EU) 2016/425 – the Personal Protective Equipment (PPE) Regulation – and Brexit on product conformity? We answer some of the commonly asked questions.
Regulation (EU) 2016/425 came into force on April 21, 2018, with the stated aims of ensuring the free movement of trade and consumer protection. It defines PPE as equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person's health or safety, including interchangeable components and connection systems.
Since January 1, 2021, and following the UK vote to leave the EU in 2016, PPE has been regulated in the UK by Regulation 2016/425. This essentially mirrors Regulation (EU) 2016/425 but with the requirement that PPE destined for UK markets must carry the UKCA Mark.
SGS offers a one-stop scheme to help manufacturers and suppliers of PPE to EU and UK markets ensure their products comply with the latest enforced regulations. To help stakeholders further understand this regulation, our experts answer your commonly asked questions.
PPE product categorization
How do I know which PPE category applies to my product?
The PPE Regulation places products into categories based on risk. It is advisable to refer to the regulation to see where your product(s) fits, but a rough guide is as follows:
- Category I – designed to protect against minimal risks
- Category II – designed to protect against risks that are not included in Categories I or III
- Category III – designed to protect against mortal dangers or risks that may seriously and irreversible affect the health of the user
If you are still unsure, then we advise you to check the PPE Guidelines document, which provides tables of each product category, and, if you remain uncertain, contact SGS for clarification.
Some commonly asked questions relate to the categorization of PPE products such as:
- Sunglasses for personal use – Category I
- Swimming goggles and full-face snorkel masks – Category I
- Swim floats – if they fall under EN 13138, Category II
- UV protective swimwear for general use – Category I
- Hi-visibility clothing and accessories – Category II
- Fabric oven gloves/mittens (home use) – Category II
- 50N buoyancy aids – Category II
- Work wear – Category I
Are there grey areas in categorization?
Yes. For example, wetsuits, UV protective swimming suits, sports clothes, etc. can be Category I but if they offer protection beyond just UV, then they may be Category II.
What do I do if I am concerned about the categorization of my PPE?
For clarification, contact either your Notified Body (NB) for EU markets, Approved Body (AB) for UK markets or an accredited laboratory within SGS.
What language must an EU Declaration of Conformity (DoC) be written in?
Article 15 of the PPE Regulation states the EU DoC must, “be translated into the language or languages required by the Member State in which the PPE is placed or made available on the market.” For the UK, this is English.
Note: the NB or AB is not required to check the DoC during the certification process, and it is the manufacturer's responsibility to draft and, if necessary, translate it into the correct language for the target market.
SGS can offer a DoC checking service, in which case the language required will depend on the expert.
Where can I find an example of a DoC?
In Annex IX of the PPE Regulation.
Is a copy of our facility’s ISO 9001 adequate to fulfill the "internal production control" requirement in the technical documentation?
Having ISO 9001 demonstrates you have a quality control system in place, but it is not adequate for the technical documentation, which must include relevant information on the processes taken.
Is it mandatory for the DoC to be made available to customers and/or final users?
Yes. A DoC is a mandatory requirement that must be supplied with the product, either as a hard copy or via website link available to the end user to view.
Which number do we affix if the product is for the UK market and the product is Category III, with Module C2 being performed by an EU NB?
For CE certification, you would use the EU NB number who conducts the surveillance audits.
If you are using the easement UKCA method, and wish to just put UKCA marking on documentation, then you cannot use the AB number as your product has not gone through the required conformity assessment route. If you choose to go through conformity assessment for Module B and C2 then you must choose a UK AB. In that situation you would use the AB number for UKCA.
For Category III PPE, are we required to have Module D certification before placing the product onto the market, or is a Module B certificate enough?
You are required to have both the Module B and Module D (or module C2) certificates at hand. You will not be able to place the product onto the market with just the Module B for Category III PPE.
How long does Module B certification last?
Module B certificates must be renewed every five years to remain compliant and allow your products to continue to be placed onto the market. However, if, during that period, your product changes or the standard is updated, you may need to contact your certification body to update the certificate.
We have a stock of manufactured hi-vis products/garments in warehouses that potentially won’t be sold until after the 2027 deadline – is there a penalty for providing goods that only have CE markings?
This depends on whether the products are deemed to be ‘placed on the market’. If an order was placed by the warehouse prior to 2027, then they are classed as being placed on the market and so you should be able to continue selling them after 2027, as long as you have documented evidence of the order. However, these rules may change.
I am an importer and my supplier provided me with CE certificates from the manufacturer. Do I need to also apply for CE certificates from the NB?
Importers have certain responsibilities as per Article 10 of the PPE Regulation. However, importers are not required to apply for certification as they are not placing the products onto the market in their own name. The manufacturer placing the product onto the market requires the relevant certification be it Module B or Module B, C2 or D.
Are there differences between the EU and UK regulations?
When the UK voted to leave the EU (Brexit), it adopted the existing PPE Regulation into its legislation and the UK Government gave it its own designation (name). The UK’s PPE regulation mirrors the EU version apart from replacing any EU aspect with UK requirements.
What is the difference between UK and GB?
The UK consists of England, Northern Ireland, Scotland and Wales, but GB only contains England, Scotland and Wales. Under the terms of the EU/UK trade deal, Northern Ireland continues to accept the CE Mark and has separate rules. UKCA relates only to GB.
What is the difference between a Notified Body (NB) and an Approved Body (AB)?
NBs are based in the EU (CE Mark) and ABs are based in the UK (UKCA Mark). They offer the same service but for their respective areas.
SGS holds accreditations as both NB and AB, enabling us to deliver a one-stop solution for PPE certification.
If I apply UKCA marking to our product without including the UKCA AB, do we need to mention the EU NB in the UKCA declaration?
This is currently unclear. The UK government has recommended that to place a product onto its market a UK DoC must be created. However, under the easement, a manufacturer can apply the UKCA logo to documentation without the need for conformity assessment through an AB. This means that the UK DoC cannot quote a UKCA certificate number or AB details. However, the allowance for using the UKCA logo is based on CE marking conformity and the certification issued.
How do I proceed with my Category III PPE when the UKCA Mark is to be affixed to the product based on a CE certificate? Since there is no AB, you are not allowed to show a NB/AB number together with the UKCA Mark.
You will be able to use the UKCA on your product documentation. However, if you do not go through the official conformity route with a UK AB, you will not be able to use the AB number on your markings, only the UKCA logo.
Do we need to remove the CE Mark from December 31, 2024, or can we have both CE and UKCA Marks on the product?
This has not been clarified. However, as per the current process, each market will look for their own conformity marking and will not check others. Therefore, if you currently have both CE and UKCA Marks, the EU will consider CE aspects and the UK will look for UKCA aspects. This should also apply after the end of the period of easement (December 31, 2027).
Can PPE carry both CE and UKCA Marks?
Yes. This is correct, but note, you can’t use AB details if your product has not gone through the necessary conformity assessment process.
How long does the UKCA conformity assessment process take?
Turnaround times (TAT) are dependent on workload and client base and so each AB is different. Currently, SGS UK has a two-week TAT.
If a product was certified in 2018 (CE marked), can the product still be sold in the UK up until the end of the extension period (December 31, 2024), even if the existing certificate expires in 2023?
The product can still be placed onto the UK market until the expiration of the certificate in 2023. You can then renew your CE Certificate, as long as it is before December 2024, and it will mean, under the easement, your product can still be placed onto GB markets until December 2027, or until your certificate expires (whichever comes sooner). However, if you do not renew you CE certificate before December 2024, then you will need to apply for CE and UKCA certification from January 1, 2025.
Do we need different representatives for the EU and UK, or we can use the same EU representative?
It is currently unclear whether the UK address needs to be manned. We would advise you to review the Importers, Distributers and Representatives section in the regulation.
The PPE Regulation asks for the certificate number in the UK DoC but there should be no AB details on the UK DoC if the product has not been assessed by a UK AB. Should this information be left out of the UKCA DoC if assessment was for the CE Mark?
This has not yet been clarified by the UK government.
We currently only provide PPE products to UK markets but are possibly looking to expand into the EU. Do we need both UKCA and CE Marks?
Yes. If you currently sell only into UK markets but wish to expand into the EU, you are required to have both UKCA and CE certifications. The EU does not accept UKCA certification.
I am placing my products onto the market in the UK. Is it enough to have CE certification or do I need to prepare the UKCA DoC as well?
If you are using the easement method, CE certification is sufficient to allow your products access to the GB market, but it is recommended you place the UKCA on documentation and have a UKCA DoC.
I have CE certification from another NB, can I apply for UKCA certification from SGS?
Yes. You can apply by contacting your local office or our facilities in Finland (Notified Body 0598) or in the UK (Approved Body 0120).
When applying for CE or UKCA certification, must test reports be from SGS?
No. We will accept any laboratory’s report as long as they are accredited and include the test/standards within their accreditation scope.
Does SGS offer both PPE product testing and CE and UKCA certification services?
Yes. Testing is conducted at one of our global laboratories and certification is through the relevant SGS NB/AB.
I have new products to be placed on markets in the EU and UK. Can I apply for CE and UKCA certificates through SGS at the same time, or do I need to get the CE before UKCA?
SGS provides a one-stop solution, allowing you to apply for CE and UKCA certification at the same time with one application.
Look at our PPE page to learn more.
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