Regulations are the most direct form of EU law - as soon as they are passed, they 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 decisions, which apply in specific cases only, involving particular authorities or individuals.
Regulations are passed either jointly by the EU Council and European Parliament, or by the Commission alone.
EU directives lay down certain end results that must be achieved in every Member State. National authorities have to adapt their laws to meet these goals, but are free to decide how to do so. Directives may concern one or more Member States, or all of them.
Each directive specifies the date by which the national laws must be adapted - giving national authorities the room for manoeuvre within the deadlines necessary to take account of differing national situations.
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).
The PPE Directive was replaced by the new Regulation (EU) 2016/425 on 21st April 2018.
Anything to be placed on the market after 21st April 2019 will need to be in compliance with the new Regulation.
Notified Bodies such as SATRA are Europe-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. In addition, 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 operates two Notified Bodies, 0321 in the UK which is Notified for PPE and Construction Products, and 2777 in Ireland, which is Notified for PPE.
There are currently around 120 PPE Notified Bodies throughout Europe and these are all subject to routine surveillance at regular intervals. It is possible to identify which Notified Body has certified the product because its name, address and unique number has to be displayed on the accompanying user information. A network of representatives from the Notified Bodies meets on a regular basis to ensure that the standards and legislation are being applied uniformly across Europe. The groups are usually referred to as Vertical or Sector and Horizontal Groups.
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.
The CE marking symbolises the conformity of the product with the applicable Community requirements imposed on the manufacturer.
The CE marking affixed to products is 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.
Ensuring compliance of CE-marked products
A key consideration for all types of personal protective equipment (PPE) is to ensure that the product has been appropriately CE marked as this is a mandatory requirement for PPE products entering the European market. This not only covers evaluation of initial examples, but also bulk production.
‘Category I’ PPE is a product which claims 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. Where possible, however, it is recommended that you have some testing carried out by an independent test centre to provide documentary evidence which can be used to support any claims you make about the product within the scope of Regulation (EU) 2016/425. Examples of Category I PPE include washing-up gloves and sunglasses.
‘Category II’ PPE claims 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. This is the end of the Notified Body official remit but SATRA would recommend purchasers include some form of ongoing production assessment. Examples of Category II products include mechanical risk PPE such as most types of safety footwear.
‘Category III’ PPE is an item which claims 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). However, purchasers may wish SATRA to carry out additional verification on their own specific batches. Examples of Category III PPE include footwear offering chainsaw cut, chemical, severe thermal and high voltage protection.
It is the responsibility of the manufacturer to ensure that the Regulation is adhered to. Working with a Notified 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.