SATRA Europe

Regulations are the most direct form of EU law and have binding legal force throughout every Member State, on a par with national laws. National governments do not have to take action themselves to implement EU Regulations.

They are different from Directives, which are addressed to national authorities, who must then take action to make them part of national law, and implement them in specific cases. Directives are used to bring different national laws into line with each other, and are particularly common in matters affecting the operation of the single market (e.g. product safety standards).

Notified Bodies such as SATRA are EU-based organisations that have been appointed by Member State Governments and notified to the European Commission on the basis of their ability to carry out the examinations and tests required for CE marking of products for Europe. They must be independent and impartial and have a high level of professional indemnity insurance. Each Notified Body will have a scope of accreditation detailing its competence in terms of directives, regulations and products. SATRA has a Notified Body for PPE (Number 2777) which is based in Ireland.

There are currently around 120 PPE Notified Bodies throughout Europe, and it is possible to identify which Notified Body has certified a product because its name, address and unique number will be displayed on the accompanying user information.

The UK left the European Union (EU) on 31st January 2020 (BREXIT). Since that time the UK has adopted its own legislation with regard to placing PPE goods onto the Great Britain (GB) market (England, Scotland & Wales). The PPE Regulation (EU) 2016/425 has now been brought into UK law and amended to apply in GB. In terms of European Harmonised standards, the UK equivalent term is a Designated standard.

The UK equivalent of a Notified Body is an Approved Body. SATRA has an Approved Body for PPE and Construction Products (Number 0321) which is based in Kettering, UK.

In this FAQ section any reference to Regulation (EU) 2016/425, CE marking, Notified Body or Harmonised standard can be taken to also equally apply to the amended UK legislation, UKCA marking UK Approved Body and Designated standard. The term Europe has been used to cover the combination of both the UK and EU.

A technical file is the term often used to describe the technical documentation that the manufacturer must prepare under PPE Regulation (EU) 2016/425. This is a mandatory requirement and one of the key obligations for manufacturers of PPE being placed on the European market.

The technical documentation must relate to a particular product design and should include the information required to show that the product complies with the requirements of the legislation which applies to it. There are many European directives and regulations which require manufacturers to draw up technical documentation. Annex III of the PPE Regulation (EU) 2016/425 lists what information must be included as part of the technical Documentation for all items of PPE.

The letters CE stand for Conformité Européenne which means European Conformity. The term initially used was EC mark but this was officially replaced by CE marking in Directive 93/68/EEC in 1993. CE marking is now used in all official EU documents.

CE marking symbolises the conformity of the product with the applicable Community requirements imposed on the manufacturer It is also a declaration by the person responsible that the product conforms to all applicable Community provisions and that the appropriate conformity assessment procedures have been completed.

CE marking is a mandatory requirement for PPE products entering the European market. This not only covers evaluation of initial examples, but also bulk production.

UKCA stands for United Kingdom Conformity Assessed. It is the UK’s version of the European CE mark and is to be used for those products placed on the UK market that were previously covered by the CE mark. This includes EU PPE legislation written into law following the departure from the EU. UKCA certification entered UK legislation on 1st January 2021. New products can only be placed on the market in the UK after 31st December 2022 if they carry the UKCA mark.

The UK equivalent of the EU PPE Regulation is known as The Personal Protective Equipment Regulations (Regulation (EU) 2016/425 as brought into UK law and amended and the Personal Protective Equipment (Enforcement) Regulations 2018.

Category I PPE are products which claim to provide protection against only minimal risks, with effects that are gradual and can be safely identified by the user in good time. This category of PPE can be self-certified, and the services of a Notified Body are not required. Examples of Category I PPE include washing-up gloves and sunglasses.

Category II PPE are products which claim to provide protection against risks of severe injury. The design of the prototype and associated documentation of these items of PPE must be certified by a Notified Body. Examples of Category II products include mechanical risk PPE such as most types of safety footwear.

Category III PPE are products which claim to provide protection against risks of mortal danger, or dangers that may seriously and irreversibly harm the user’s health. The design of the prototype and associated documentation of such items of PPE must be certified by a Notified Body. In addition, a Notified Body must also be involved with assessment of subsequent production, either by product testing or assessment of the manufacturing quality system (Modules C2 or D of the Regulation). Examples of Category III PPE include footwear offering chainsaw cut, chemical, severe thermal and high voltage protection.

It is the responsibility of the manufacturer and other economic operators involved in the supply of PPE to ensure that the Regulation is adhered to. Working with a Body such as SATRA will help you to achieve this. Failure to comply can lead to the recall and replacement of equipment, a substantial fine and a prison sentence.