EU – PPE Update: Sun-safe Clothing now Classified as PPE Category I

Vol. 1059 | 01 Mar 2019

Previously

Clothing designed and marketed as offering solar ultraviolet (UV) protection could be tested according to a variety of existing UV transmission test methods. This type of clothing previously wasn’t mentioned under the PPE directive 89/686/EEC.

Currently Regulation (EU) 2016/425 [ec.europa.eu]

The new European PPE Regulation 2016/425 was listed in the Official Journal on 21^st April 2016, starting its two-year transition period to replace the current Directive 89/686/EEC. This new regulation now mentions that PPE designed to protect the skin against non-ionising radiation must be capable of absorbing or reflecting the majority of the energy radiated in the harmful wavelengths.

Non-ionising radiation (NIR) is the term used to describe the part of the electromagnetic spectrum covering two main regions, namely optical radiation (ultraviolet, visible and infrared) and electromagnetic fields (EMFs) (power frequencies, microwaves and radio frequencies).

Guidelines PPE Regulation Guidelines [ec.europa.eu]

Categorisation guide point 16.6, “Skin protection against natural UV radiation - All garments, including partial or whole body clothing, caps and helmets, gloves, and shoes, designed and manufactured to have specific UV-protective properties against natural UV radiation” are considered PPE Category I.

If the clothing is “designed and manufactured to have specific UV-protective properties against natural UV radiation” then this applies to your garment.

What should I do?

The PPE regulation guidelines issued by the European Commission in April 2018 specify that all garments including partial or whole-body clothing, caps and helmets, gloves, and shoes, designed and manufactured to have specific UV-protective properties against natural UV radiation are now classed as category I PPE.

It is recommended that the testing of garments that claim to offer solar UV protection should be carried out according to BS EN 13758-2 and hats should be tested according to BS 8466. 

Product labelling will also need to be revised to reflect the new requirements as they will require the CE mark.

A Technical File shall be written to support the product and shall contain the following information as required by Annex III of the PPE Regulation 2016/425

1. complete description of the PPE and of its intended use
2. an assessment of the risks against which the PPE is intended to protect
3. a list of the essential health and safety requirements that are applicable to the PPE
4. design and manufacturing drawings and schemes of the PPE and of its components, sub-assemblies and circuits
5. the descriptions and explanations necessary for the understanding of the drawings and schemes referred to in point (d) and of the operation of the PPE
6. the references of the harmonised standards referred to in Article 14 that have been applied for the design and manufacture of the PPE. In the event of partial application of harmonised standards, the documentation shall specify the parts which have been applied
7. where harmonised standards have not been applied or have been only partially applied, descriptions of the other technical specifications that have been applied in order to satisfy the applicable essential health and safety requirements
8. the results of the design calculations, inspections and examinations carried out to verify the conformity of the PPE with the applicable essential health and safety requirements
9. reports on the tests carried out to verify the conformity of the PPE with the applicable essential health and safety requirements and, where appropriate, to establish the relevant protection class
10. a description of the means used by the manufacturer during the production of the PPE to ensure the conformity of the PPE produced with the design specifications
11. a copy of the manufacturer's instructions and information set out in point 1.4 of Annex II
12. for PPE produced as a single unit to fit an individual user, all the necessary instructions for manufacturing such PPE on the basis of the approved basic model
13. for PPE produced in series where each item is adapted to fit an individual user, a description of the measures to be taken by the manufacturer during the fitting and production process to ensure that each item of PPE complies with the approved type and with the applicable essential health and safety requirements.

As well as the above the manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured PPE with the technical documentation and with the applicable requirements of this Regulation.

The manufacturer shall affix the CE Mark to each item of PPE and draw up a written EU Declaration of Conformity. This, along with the technical file shall be kept for 10 years after the PPE was placed on the market

Timeline

Products placed on the market after 21^st April 2019 must meet the essential health and safety requirements laid down in the regulation.

For additional information please contact:

Dave Smith
dave.smith@intertek.com
Phone: +44 (0)1942 265700