Regulation (EU) 2016/425 on Personal Protective Equipment (the “EU PPE Regulation”) regulates the import or sale of PPE in the EU. It sets out:
The EU PPE Regulation currently applies, and completely replaces the existing EU Personal Protection Equipment Directive 89/686/EEC (1989 Directive) on April 21, 2018. It is possible to still sell products that conform to the requirements in the 1989 Directive, so long as these are imported into or first sold in the EU before April 21, 2019. EC type-examination certificates and approval decisions issued under the 1989 Directive also remain valid until April 21, 2023, or until they expire (whichever is sooner).
EU member states can still make laws on the use of PPE, as long as those requirements do not change the design of PPE, which conforms to the requirements under the EU PPE Regulation.
It is your responsibility to comply with the EU requirements if you are selling PPE in the EU. You must also comply with any other national requirements in the countries in which you sell these products.
Please see further below on this page for more information about EU requirements.
From 1 January 2021, an amended version of the EU PPE Regulation applies to the import or sale of PPE in the UK as a result of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (the “UK Regulation on PPE”). It sets out:
Important changes in the UK requirements starting 1 January 2021 are noted below:
To learn more about where the changes in UK requirements apply, see Where do the UK requirements for PPE apply?
Different rules apply to goods you sell in: (1) Great Britain (England, Scotland and Wales); and (2) Northern Ireland.
It is your responsibility to comply with the UK requirements if you are selling PPE in the UK. If you also sell PPE on Amazon EU website(s), then you must also comply with the EU PPE Regulation and with other national requirements in the countries in which you sell these products.
For more information on UK requirements, see What products do the UK requirements for PPE apply to?
This material is for informational purposes and you should not take it as a substitute for legal advice. We encourage you to consult your legal counsel for any concerns about the laws and regulations concerning your product. This material only reflects the position at the date of writing and requirements across the EU and in the UK may change. You should refer to current UK Brexit guidance about your products available on this page to learn more about changes that may affect you from 1 January 2021.
The UK requirements for PPE apply to all products sold in the UK, but the provisions apply differently to Great Britain ("GB") (England, Scotland and Wales) and Northern Ireland ("NI"). You can read more about the position in Northern Ireland detailed below on this page.
The EU requirements apply to PPE, which is generally defined as equipment designed to protect the wearer/user against risks to that person's health or safety. PPE includes any individual parts that are essential for the equipment’s protective function, or to connect that equipment to an external device or to a reliable anchorage point. However, some products are excluded from the EU PPE Regulation and are covered by other laws including those products that are designed for:
The UK requirements apply to PPE, which is generally defined as equipment designed to protect the wearer/user against risks to that person's health or safety. PPE includes any individual parts that are essential for the equipment’s protective function, or to connect that equipment to an external device or to a reliable anchorage point. However, some products are excluded from the UK’s regulatory regime (and are covered by other laws) including those that are designed for:
Manufacturers must ensure that PPE has been designed and manufactured to conform to the applicable health and safety requirements set out in Annex II of the EU PPE Regulation. Manufacturers must draw up the Technical Documentation that specifies how they have ensured their products’ conformity with Annex II, and follow the applicable conformity assessment procedure. The conformity assessment will vary depending on the categorization of the product. Where the manufacturer has demonstrated their product’s compliance by the appropriate procedure, they must draw up the Declaration of Conformity and affix the CE mark to the product (or, where that is not possible, its packaging or accompanying documentation).
The manufacturer and any other party importing the product into the EU must keep copies of the Technical Documentation and the Declaration of Conformity for 10 years after the last unit of the product has been sold in/imported into the EU and provide it on request to relevant national authorities. Importers and distributors of PPE are also responsible for checking that they only import/sell compliant PPE in the EU.
Manufacturers must ensure that PPE has been designed and manufactured to conform to the applicable health and safety requirements set out in Annex II of the EU PPE Regulation and UK Regulation on PPE. Manufacturers must draw up the Technical Documentation that specifies how they have ensured their products’ conformity with Annex II, and follow the applicable conformity assessment procedure. The conformity assessment will vary depending on the categorization of the product. Examples of information to be included in the Technical Documentation are:
Where the manufacturer has demonstrated their product’s compliance by the appropriate procedure, they must draw up the declaration of conformity and affix a conformity mark to the product (or, where that is not possible, its packaging or accompanying documentation) as follows:
The manufacturer and any other party importing the product into the UK must keep copies of the Technical Documentation and the declaration of conformity for 10 years after the last unit of the product has been sold/imported and provide it on request to relevant national authorities. Importers and distributors of PPE are also responsible for checking that they only import/sell compliant PPE in the UK.
The following information must be included on the product itself or, where that is not
possible, on its packaging or in a document accompanying the product:
Also, under the EU PPE Regulation, each individual piece of PPE must be accompanied by the declaration of conformity. Manufacturers may comply with this obligation by including in the instructions and information the internet address where the complete declaration of conformity can be found.
The following information must be included on the product itself or, where that is not
possible, on its packaging or in a document accompanying the product:
Also, under the EU PPE Regulation, each individual piece of PPE must be accompanied by the declaration of conformity. Manufacturers may comply with this obligation by including in the instructions and information, the internet address where the complete declaration of conformity can be found.
Please note that different rules will apply in NI from 1 January 2021 as a result of the Northern Ireland Protocol. In particular:
Manufactures and importers should carry out sample testing of PPE, investigate and keep a register of complaints of non-conforming PPE and PPE recalls, and keep distributors informed of any such issues.
In case of any non-conforming PPE, manufacturers and importers must immediately take the corrective measures necessary to bring that PPE into conformity, and withdraw or recall it, as appropriate. Furthermore, where the PPE presents a safety risk, manufacturers, importers and distributors are also obliged to immediately inform the competent national authorities of the Member States in which they have sold/imported the PPE of the safety risk, giving details of the non-conformity and any corrective measures taken (in the UK, inform the competent authorities ((Health and Safety Executive or Trading Standards).
The UK Government has released guidance on selling products in GB and NI from 1 January 2021. This guidance provides information for manufacturers, importers and distributors regarding compliance requirements from 1 January 2021, including on:
We encourage you to review this guidance (linked below), alongside any other specific UK Government Guidance that applies to your product. You should consult your legal counsel if you have questions about how the laws and regulations apply to your products from 1 January 2021.
The Brexit guidance can be found here:
GB:
NI:
We strongly encourage you to visit the European Commission’s website: http://ec.europa.eu/growth/sectors/mechanical-engineering/personal-protective-equipment_en for more information on PPE.
For more information on the requirements for PPE in the UK, visit the UK Government website: https://www.hse.gov.uk/toolbox/ppe.htm. We also encourage you to visit the Business Companion website, which contains guidance on UK product compliance rules: https://www.businesscompanion.info/en/get-started https://www.businesscompanion.info/focus/ppe