Those working within the PPE industry will be well aware of the emergence of non-compliant products on the market as the pandemic took hold. Now as things return to normal, the issue remains a key matter to be addressed. So now more than ever, regulatory health and safety markings should be front of mind.

Change is also afoot. With the new UKCA markings now coming into force, manufacturers, importers and distributors need to know where they stand going forward.

With guidance from the British Safety Industry Federation (BSIF), the UK’s leading trade body within the safety industry, we have all the information you need to recognise safe and compliant PPE.

The BSIF Registered Safety Supplier Scheme audits businesses who place or make available PPE in the UK ensuring compliance with the PPE Regulation. All Eurosafe members are BSIF Registered Safety Suppliers.

The background to the change

Since the early 1990s, it was necessary for personal protective equipment (PPE) to be CE marked if it was being placed on the market anywhere in the European Union. This would demonstrate to distributors and end users that products met the essential health and safety requirements of PPE legislation at the time.

Now that the UK has left the EU, new rules have been created to ensure that domestic products are still held to strict health and safety standards to protect end users.

As a result, the previous CE marking was replaced with a new UKCA (United Kingdom Conformity Assessment) mark. This applies to England, Scotland and Wales with a separate set of rules for Northern Ireland. The new mark has now been in place since its introduction on 1st January 2021 and an initial transition period was provided until 31st December 2021. This has now been extended to 31st December 2022, so businesses can continue to use the CE mark until that date. PPE lawfully placed on the market with a CE marking by 11pm 31st December 2022 can continue to circulate on the GB market after this date with no requirement to re-test or re-mark such PPE under UKCA.

UKCA is a mandatory mark on a product to indicate that it conforms to Great British legislation. The manufacturer or, if mandated, their authorised representative will be responsible for affixing the UKCA mark to the product, which is the same principle as CE marking, but for the GB market.

The Personal Protective Equipment Regulation (EU) 2016/425, whose details we are all familiar with, was originally adopted and brought across as ‘Regulation 2016/425 on Personal Protective Equipment as brought into UK law and amended’. The title of the UK PPE regulation to be used on official documents has not been formally specified by the Department for Business, Energy and Industrial Strategy (BEIS). However, the recommendation of the British Safety Industry Federation, and agreed by all of the ‘Approved Bodies’ is that it will be referenced as ‘Regulation 2016/435 on personal protective equipment, as amended to apply in GB’ when placing product on the market in Great Britain.

What has changed in the way products are marked?

“Having left the EU, the transition and renewal of our product regulatory system was always going to mean some disruption. However, the good news here is that “Regulation 2016/425 on Personal Protective Equipment as brought into UK law and amended” is technically the same as the EU Regulation it replaces.”

Alan Murray, Chief Executive Officer, BSIF

There are minimal differences, mainly administrative in nature, meaning that the majority of products that meet the technical requirements for one will meet the requirements for the other for the foreseeable future.

Just as before, PPE is divided into 3 categories, based on the severity risk that the product is designed to protect against. We still have Category I, II and III with the requirements on manufacturers for design testing and conformity assessment remaining the same.

However, one thing to be aware of is that conformity assessment of PPE under UKCA can only be done by appointed UK Approved Bodies. The number of PPE conformity assessment bodies has dropped from well over 100 throughout the EU, to only 14 able to provide this service in the UK, although this is growing. Under the EU regime, these approved bodies could be identified through the NANDO listing of Notified Bodies. Now under UKCA, the list of Bodies scoped and approved for PPE can be found here.

Government easing and amended regulations

On June 20th 2022, the UK Government published some ‘easements’ to their earlier guidance to help UK businesses comply as capacity for product approval had reduced significantly. This was followed by sector specific guidance on July 26th 2022.

The main change created by these easements allows the use of the existing CE mark as the basis for applying the UKCA mark and this is further explained in the Obligations of manufacturers section.

What are the current requirements for PPE under the Amended PPE Regulations?

Scope There has been no change to the scope of definition of what PPE is. Its purpose also remains the same. There is no change to the uses where PPE would be considered to be out of the scope of the regulation.
Product Standards PPE must perform to the protective claims than manufacturers make when placing products on the market. Under the EU regime, these were known as Harmonised Standards, but under UKCA standards, they are now called ‘Designated Standards’. Standards are subject to change and any new and/or reviewed standards can be proposed by the British Standards Institution to BEIS for Designation. There will then be a 28-day consultation followed by it being designated unless there is a justifiable objection.

PPE can still be conformity assessed and carry the UKCA mark even though it has not been assessed against a designated standard, this is often known as the technical file route. It will not carry a presumption of conformity to the essential health and safety requirements and the approved body will need to do further assessment to confirm that it does, prior to it being placed on the market. A list of the UK “Designated Standards” can be found here.

Obligations of Manufacturers Under the latest guidance, a manufacturer can use existing CE certification as the basis for applying the UKCA mark. This means that any PPE which has been correctly CE assessed and certified by a Notified Body before January 1st 2023 can have a UKCA mark without reference to or the involvement of any UK Approved Body. The product will still need to bear the UKCA marking, and it will need to undergo conformity assessment by a UK Approved Body at the expiry of the CE certificate, or after 5 years (31st December 2027) – whichever is sooner.

Arrangements for independent quality assurance for Category III products are included and under the government easement, the quality assurance modules C2 or D can continue with a non-UK Notified Body. Generally, speaking all other obligations are the same as under the EU Regulation.

Importantly a UK Declaration of Conformity (DoC) must be drawn up and it must accompany the product to the end user. Where the manufacturer is using existing CE certification as the basis to demonstrate compliance with UKCA, they should include in the DoC the list of relevant UK Designated Standards and the equivalent EU harmonised standards that apply, as well as the details of the EU Notified Body responsible.
The UKCA mark should be on the product visibly, legibly and indelibly. However, until 31st of December 2025, the UKCA mark can be affixed by a label on packaging or on documents accompanying the product. The BSIF Registered Safety Supplier Scheme (RSSS) helps the whole PPE supply chain demonstrate that they discharge all of their regulatory responsibilities.

Obligations of Importers An importer is a person or business based in the UK who places PPE on the GB market from a country outside the UK. This means that UK businesses that used to act as a ‘distributor’ before 1 January 2021 legally become an ‘importer’ if they place products from an EEA country on the GB market. A key principle underpinning product compliance and safety is traceability of the product back to its source and therefore it is essential that an Importer’s details are available as necessary.

Importers will have legal responsibilities that go beyond those of distributors. This includes ensuring that their trademark or name and postal address is on the product or where this is not possible, due to the nature or size of the product, on its packaging or accompanying documentation
While the UK was part of the EU business who sourced PPE from the EEA countries (or Switzerland) were classed as distributors. In this scenario the distributor would then become an importer. Recognising the extra responsibilities which the business now carries, the UK is applying a transitional period until the 31st of December 2025 to allow UK suppliers of PPE sourced from the EEA or Switzerland to provide their details on accompanying documentation as an alternative to putting them on the product itself.

Obligations of Distributors While manufacturers and importers place product on the market, a distributor role is described as ‘making that product available on the market’. It is true to say that manufacturers and importers can make product available as well as placing it on the market, however, strictly speaking, a distributor’s role is to then make that product available.

What do PPE distributors have to look out for?

Before making PPE available to the Great British market, distributors must act with due care to ensure that it is in conformity with the latest PPE Regulation and health and safety requirements. They also have to make sure that it bears the UKCA marking and is accompanied by clear, legible instructions that are in easily understandable English. They should also check that the manufacturer and importer have complied with the marking requirements regarding required labelling.

Distributors must ensure that any PPE under their care is safely stored and transported in such a way that doesn’t jeopardise its conformity with the essential health and safety requirements.

If a distributor has any reason to believe that the PPE they are making available on the market is not conforming with the 2016 Regulation, they must immediately take the corrective measures necessary to bring the PPE into conformity, to withdraw it or recall it. Where PPE presents a risk, distributors shall immediately inform the enforcement authority, giving details, in particular, of the non-conformity and of any corrective measures taken.

Distributors must also, in response to a reasoned request from the enforcement authority, provide all information and documentation, in paper or electronic form, necessary to demonstrate the conformity of PPE in a language which can be easily understood by that authority. They should then cooperate on any action taken to eliminate the risks posed by PPE that they have placed on the Great British market.

What if I’m placing products in the Northern Ireland market?

The CE marking continues in Northern Ireland as it remains aligned with the EU single market for goods. Products with a CE marking are still acceptable and if and where appropriate, a UKNI mark should be used instead of UKCA. These differences will remain as long as the Northern Ireland Protocol is in place.

The government committed to unfettered access for qualifying Northern Ireland goods to the rest of the UK market after 1st January 2021. Products that can be ‘placed on the market’ in Northern Ireland in accordance with the legislation, as it applies to Northern Ireland, can be sold in the rest of the UK without any additional approvals.

Ensuring quality and reducing non-conformity

A number of bodies are in place to make sure the transition is smooth and the products available in the UK provide distributors and end users with confidence and appropriate protection.

The BSIF Registered Safety Supplier Scheme audits businesses who place or make available PPE in the UK ensuring compliance with the PPE Regulation. All Eurosafe members are BSIF Registered Safety Suppliers

From CE to UKCA

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