Personal Protective Equipment (PPE) placed on the market in Great Britain
From 1st January 2021, the United Kingdom has introduced a new conformity assessment regime for goods placed on the market in Great Britain (England, Wales and Scotland). The UKCA (UK Conformity Assessed) marking is the new UK Product marking that covers most goods which previously required the CE marking.
The European PPE regulation (EU) 2016/425 has been adopted into the UK law and amended for use. The procedures, modules and risk categories have all been incorporated, so PPE has to go through the same procedures for the UKCA marks as it did for the CE marking.
The notified bodies based in the United Kingdom have all now become UK-Approved Bodies with the same scope as before. The European list of Harmonised Standards was adopted as UK Designated Standards.
PPE items sold in Great Britain that have product approvals and certificates from a UK-Approved Body will need to be marked with the UKCA mark and have information and declarations referencing the relevant UK legislation.
CE certificates issued by the UK-notified bodies before the end of 2020 to the EU PPE Regulation and the PPE Directive, and held in the UK by a UK-Approved body,are still valid for the UKCA marking.
- For Category I and Category II PPE Marking
|UKCA mark replaces the CE mark|
- For Category III Marking
For Category III, the number of the UK-Approved Body carrying out the annual assessment (Module C2 or Module D) must be included.
|UKCA mark replaces the CE mark *Module C2/D Approved Body Number beside the UKCA mark|
*XXXX– Approved Body number auditing the manufacturer
The UKCA mark must be at least 5 mm in height. The rules regarding CE marking also apply to the UKCA:
“shall be affixed visibly, legibly and indelibly to the PPE. Whereas that is not possible or not warranted on account of the nature of the PPE, it shall be affixed to the packing and to the documents accompanying the PPE.”
All other marking and labelling (pictograms, care labelling) remain the same. Standards references remain the same.
Placing product on the market in Northern Ireland
Northern Ireland has different rules to Great Britain (the mainland UK). From 1st January 2021, PPE can be placed in the Northern Ireland market with either the CE mark, using CE certification held by an EU27 notified body or with CE + UKNI marking using UKCA certification.
PPE USER INFORMATION & DECLARATION OF CONFORMITY
For updating CE User Information and the Declaration of Conformity to UKCA, the following is changed:
- The reference to the EU PPE Regulation changes to the UK PPE Regulations
- Reference to Notified Body replaced by Approved Body
- “EU” is removed in reference to type-examination (Module B)
- Reference to harmonised standards replaced by designated standards
For example, in case of User Information:
“This item is classed as Personal Protective Equipment (PPE) by the UK Personal Protective Equipment Regulations (Regulation 2016/425 as brought into the UK law and amended)”
“BTTG, Approved Body 0338, Manchester M17 1EH, performed the type-examination (Module B).”
“(for Category III PPE) The item is subject to the conformity assessment procedure Module C2/D under surveillance of BTTG, Approved Body 0338, Manchester M17 1EH”
“This item complies with the designated standard EN ISO 12345.2020”
For example, for the Declaration of Conformity:
“DECLARATION OF CONFORMITY # ……………….”
“The object of the declaration described is in conformity with the Personal Protective Equipment Regulations (Regulation 2016/425 as brought into UL law and amended)”
“The object complies with the designated standard EN ISO 12345:2020”
“The Approved Body BTTG, 0338 performed the type-examination (Module B) and issued the type-examination certificate XXXXXXXXXXX”
“(for Category III PPE) The PPE is subject to the conformity assessment procedure Module C2/D under surveillance of BTTG, Approved Body 0338, Manchester M17 1EH”
All other information, including instructions, standard numbers and classification remain the same.
Tarasafe is approved for UKCA Cat III Module D productions at its facilities, and you can get in touch with our marketing team for further details.