Personal Protective Equipment (PPE)

By Mari Cruz Lorente, Eurofins Softlines & Leather – Toys & Hardlines

March 1, 2021

Personal Protective Equipment (PPE)

Regulation 2016/425 on personal protective equipment is brought into UK law and amended. They set out the legal requirements for the safety of Personal Protective Equipment supplied on the Great Britain market.

It is important to bear in mind that PPE must meet others legislation from UK REACH and Persistent Organic Pollutants Regulations, among others.

From 1^st January 2021, the main points are:

• The UKCA mark is the new product marking requirement.
• The UKCA marking will become compulsory from 1st January 2022.
• Until 31st December 2022, the UKCA marking may be affixed to a label or a document accompanying the PPE.
• Manufacturers can self-declare, where allowed, or have a conformity assessment by a UK-approved body and affix the UKCA marking, where required.
• Where the manufacturer follows GB rules and affixes a UKCA marking, the manufacturer must draw up a Declaration of Conformity setting out the (UK) enactments with which the PPE is compliant.
• Declaration of conformity and technical documentation are prepared in or translated into English and must be maintained for a period of 10 years and made available to enforcement authorities on request.
• Authorised Representatives must be established in the UK.
• UK Notified Bodies automatically become UK-approved Bodies.
• ‘UK ‘designated standards’ replace ‘harmonised standards’.
• There is an additional circumstance under which an importer does not need to mark identification information on the PPE itself. If the importer imports the PPE from an EEA state or Switzerland and places it on the GB market before 31st December 2022, the importer can set out the identification information (name, address etc) on the packaging or in a document accompanying the PPE.

UKCA Marking

The UKCA (United Kingdom Conformity Assessed) mark is the new product marking requirement for certifying that the product meets the UK Regulations and will replace CE marking and ‘reverse epsilon’ marking (aerosols) for the GB market (England, Wales and Scotland).

UKCA marking
	Characteristics It has to be visibly, legibly and indelibly on the product. Logo size: at least 5mm in height. Logo proportions should remain constant. If, due to characteristics of the product, is not possible to mark on product, it should be affixed to the packaging and the accompanying documents.
Placing manufactured goods on the market in Great Britain
From 1st January 2021	From 1st January 2022	From 1st January 2023
UKCA mark can be used (on the label, product or accompanying documents)	UKCA marking us required (in most cases). Until 1st January 2023, there is the option to attach the UKCA mark on a label attached to the product or document accompanying the product.	UKCA mark must be permanently affixed directly to the product.
CE and UKCA mark can coexist until 1st January 2022 (Transition period).*	CE mark will not be accepted for the UK market.	CE mark will not be accepted for the UK market.
*CE marking is only valid in Great Britain for areas where GB and EU rules remain the same. If the EU changes its rules and you CE mark your product on the basis of those new rules, you will not be able to use the CE marking to sell in Great Britain, even before 31 December 2021.

UKNI Marking

The UKNI marking is a new conformity marking for products placed on the market in Northern Ireland which have undergone mandatory third-party conformity assessment by a body based in the UK.

The Northern Ireland Protocol came into force from 1st January 2021. For as long as it is in force, Northern Ireland will align with relevant EU rules relating to the placing on the market of manufactured goods.

UKNI Marking
	Characteristics - It has to be visibly, legibly and indelibly on the product. - Logo size: at least 5mm in height. - Logo proportions should remain constant.
From 1st January 2021
Placing qualifying Northern Ireland goods on the market in Great Britain (unfettered access)		Placing goods on the market in Northern Ireland
CE mark or CE/UKNI mark accepted for new & existing products.		CE mark accepted. Manufactured goods being placed on the market in NI using an EU conformity assessment body.
CE mark accepted if third-party assessment is made from EU-27 Notified Body.	UKNI mark accepted if third-party assessment is made from UK-approved Body.
Note: The UKNI marking is not recognised on the EU market.   This means these goods must be manufactured to EU rules and cannot be assessed by a body based in the UK.  For European market, the CE mark must appear without the UKNI mark. The CE/UKNI mark are not acceptable in the EU market.

Packaging

The responsible person (packer/filler, importer, brand, trade mark or other distinctive mark) is obliged to ensure that all packaging complies with the essential requirements and heavy metal limits (Lead, Cadmium, Mercury, Hexavalent Chromium), among others substance, and requirements according to packaging legislation, UK REACH and Persistent Organic Pollutants Regulations, among others.

When putting goods on the market, the responsible person must also account for packaging waste. The aim is to reduce the amount of packaging waste that ends up in a landfill.

The main requirements are:

• Packaging volume and weight must be the minimum amount to maintain the necessary levels of safety, hygiene and conformity for the packed product and for the consumer.
• Packaging must be manufactured so as to permit reuse or recovery in accordance with specific requirements.
• Noxious or hazardous substances in packaging must be minimised in emissions, ash or leachate from incineration or landfill disposal.

The relevant Regulations are: