We have compiled this Expert Advice Sheet to provide those purchasing PPE with the information that they will need now that the UK has left the EU and the transition period finished on December 31st, 2020. We guide you through changes in Regulations, the standards, and assessment bodies and provide an overview of the introduction of the new UKCA marking.
Legislation
The withdrawal of the UK from the European Union has meant the introduction of new legislation. Currently, this mirrors EU legislation and there is one set of amended PPE Regulations. However, some of the provisions may apply differently in Great Britain (GB) and in Northern Ireland (NI).
EU Regulation 2016/425 on personal protective equipment has been applicable in the UK since its entry into force on 21st April 2018
The Personal Protective Equipment (Enforcement) Regulations 2018 implemented the 2016 Regulation into UK law and provides a system for the enforcement of the Regulation. This Regulation sets out the ‘essential health and safety requirements’ that must be met before PPE products can be placed on the market. The purpose of the legislation is to ensure safe and effective products are placed on the market by requiring manufacturers to demonstrate that their products have been tested and are compliant with these requirements.
The EU Withdrawal Act 2018 preserves these Regulations and enables them to be amended so that they continue to function effectively now that the UK has left the EU.
The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 have been introduced to fix any deficiencies that arose from the UK leaving the EU (such as references to EU institutions) and make specific provision for the GB market.
Therefore, there is one set of Amended PPE Regulations
However, some of the provisions apply differently in Great Britain (GB) and in Northern Ireland (NI) (for as long as the Northern Ireland Protocol is in force).
Designated standards
From 1st January 2021 EN standards that manufacturers currently work to, will become “UK Designated Standards”. The technical requirements and the conformity assessment process and standards that are followed to demonstrate conformity will be largely the same as they are now, however they may diverge in the future.
European (EN) Standards
EN standards are developed by a recognised European Standards Organisation. Manufacturers, other economic operators, or conformity assessment bodies use standards to demonstrate that products, services, or processes conform with the applicable EU regulations. From 1st January 2021 EN standards that manufacturers currently work to, will become “UK Designated Standards”.
UK Designated Standards
A designated standard is a standard, developed by consensus, which may be recognised by government in part or in full by publishing the reference on GOV.UK. Depending on the product, it can be a standard published by specific recognised standardisation bodies including:
- British Standards Institution (BSI)
- European Committee for Standardisation (CEN)
- European Committee for Electrotechnical Standardisation (Cenelec)
- European Telecommunications Standards Institute (ETSI)
Prefixes
Designated standards will be prefixed “BS”, “BS EN”, “BS ISO” “BS EN ISO” “EN ISO” or “EN IEC”
UK conformity assessment bodies
From 1 January 2021 most UK-based notified bodies will become UK conformity assessment bodies
A conformity assessment body Is registered to assess products for the GB market against essential health and safety requirements. They carry out the procedures for conformity assessment and certification as set out in the 2016 Regulation.
The UK has established a new framework for UK based bodies to assess PPE against GB rules.
- Existing UK notified bodies have been granted new UK conformity assessment body’ status and listed on a new UK database. They do not need to seek re-accreditation and retain their 4-digit identification body number.
- New UK conformity assessment bodies will be assigned a number by the Office for Product Safety and Standards on behalf of the Secretary of State.
Transitional arrangements
Transitional arrangements have been put in place to allow products that are fully manufactured and placed on the market before 1st January 2021 and existing CE marked stock to circulate on the GB market.
Products placed on the market before 1 January 2021
If an individual, fully manufactured product has been placed on the UK market (either in Northern Ireland or Great Britain) before 1 January 2021, it can continue to circulate until it reaches its end user and does not need to comply with the changes that take effect from 1 January 2021.
‘Placed on the market’ means that there is an ‘offer of an agreement’ to transfer ownership or possession or other rights in the product and does not require physical transfer of the good.
The relevant economic operator should be able to provide proof that a product was placed on the market before 1 January 2021.
Existing CE marked stock
CE marked PPE can be placed on the GB market until ` 31 December 2021 if it has been either
- self-declared as compliant (where permissible),
or
- compliance must and has been demonstrated through assessment by an EU-recognised conformity assessment body (notified body)
PPE lawfully placed on the market with a CE marking by 31 December 2021 can continue to circulate on the GB market after this date
The introduction of UK Conformity Assessed (UKCA) marking
The UK Conformity Assessed (UKCA) marking:
The UK Conformity Assessed (UKCA) marking is a new marking that will be placed on products as a means of showing conformance with the relevant UK legislation.
The UKCA mark will become Great Britain’s equivalent of the CE mark.
Products affected:
The UKCA marking covers most goods which previously required the CE marking, this includes Personal Protection Equipment (PPE). This means that category II and III PPE for sale in Great Britain will need a UKCA certificate from a UK Conformity Assessment Body. (Or a CE mark during the transitional period).
NB: Separate rules apply to medical devices.
Great Britain: The UKCA marking will be used for goods being placed on the market in Great Britain (England, Wales and Scotland).
Northern Ireland: The UKCA marking will not be recognised in Northern Ireland. Products placed on the market in Northern Ireland will require either the CE marking or UK(NI) marking.
The European Union (EU): The UKCA marking will not be recognised on the EU market. Products currently requiring a CE marking will still need a CE marking for sale in the EU.
Relevant dates and timelines from 1 January 2021
From 1 January 2021
the UKCA marking will come into force and will start to appear on products.
From 1 January 2021
CE marking will continue to be recognised in the UK until the end of 2021. Therefore, in most cases you will be able to continue to purchase and use PPE bearing the CE marking in the UK until that date.
However, there are some exceptions to this which are outlined in the panel to the right
From 1 January 2022
Only product bearing the UKCA marking will be acceptable in Great Britain.
CE marking will not be recognised in Great Britain, however, a product bearing the CE marking would still be valid for sale in the UK so long as it was also UKCA marked and complied with the relevant UK rules.
Exceptions
- Changes in EU Rules
The CE marking will only be valid in Great Britain for areas where GB and EU standards remain the same.
If the EU changes its standards and a product is CE marked on the basis of those new standards you should not purchase it in Great Britain, even if you are purchasing it before the deadline of 31 December 2021.
- A product has been manufactured post January 2021 and conformity assessment has NOT been transferred to an EU notified body.
It is important to note that CE markings based on EU type examination certificates issued by a Notified Body based in the UK become invalid as of the 1 January 2021.
After this date a product will need to bear UKCA marking if conformity assessment has been carried out by a UK conformity assessment body and the manufacturer hasn’t transferred their conformity assessment files from the UK body to an EU notified body before 1 January 2021. During the transition period, the manufacturer can affix the UKCA mark to the packaging instead of the product.
SKANWEAR® is a manufacturer of Arc & Flame Protective Clothing & PPE which is manufacturer under the brand of STRATA Protection®. Customers can have the reassurance that our compliance team are working to ensure that all legal compliance requirements are met on or before the designated time frames.
