In this section
Last updated: 10 August 2020
In the context of PPE and many EU product safety regulations, a distributer is defined as ‘any legal person in the supply chain, other than the manufacturer or the importer, who makes PPE available on the market.’ Therefore this includes the activities of retailers.
Distributers make PPE available on the market, whereas manufacturers and importers place PPE on the market. ‘Making available on the market’ is defined as ‘any supply of PPE for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge.’
If you are a distributor or retailer you must check that the PPE products that you make available on the market are legally compliant by acting with due care.
There are COVID-19 easements in place and the following takes these into account:
Distributors must verify (or note where applicable) that the PPE:-
- Is in conformity with the PPE Regulation (Regulation (EU) 2016/425), i.e. it still meets the EHSRs
- Need not have a CE Marking or completed Declaration of Conformity (thanks to the easements) If there is no CE mark on the product, be sure that this is because the product is subject to legitimate COVID-19 easements, rather than being omitted for any other reason.
- Do a visual inspection of the PPE, is it robust - will it fall apart with the slightest amount of effort? Does the PPE have sharp edges?
- For use in the NHS, it does not have to undergo conformity assessment procedures but can be imported without the CE Marking or Declaration of Conformity, providing it meets the EHSRs
- For use in other sectors (non NHS) it can be sold providing conformity assessment procedures have begun but not necessarily completed. In these circumstances, the products will not be CE marked or have a completed Declaration of Conformity.
- Is accompanied by instructions and safety information, in English
- That the manufacturer and importer have complied with all labelling requirements
- Must also ensure that whilst PPE is under their responsibility, storage or transport conditions do not threaten its condition
- If concerned about PPE that may not be in conformity with the Regulations then it should be withdrawn or recalled, as appropriate. Where it presents a risk, the enforcement authority* should be informed immediately and details provided, including about any corrective measures taken. The distributor/retailer should work with the enforcement authority, co-operating with its requests
*The UK enforcement authority is the Secretary of State who exercises these powers via the Office for Product Safety and Standards (OPSS, within the Department for Business, Energy and Industrial Strategy)