KANBrief 4/13
The PPE Directive was one of the first New Approach directives, being drawn up in 1989. It governs the placing of personal protective equipment such as safety footwear, protective clothing, cycle helmets and sunglasses on the market within the EU. Revision was discussed only a few years later (See for example KANBrief 2/02, "The PPE Directive: a basis for standardization activity"), but was not actually begun until the New Legislative Framework had been adopted.
What is going to change with respect to PPE?
The scope of the regulation has been extended with the addition of PPE for private use for protection against moisture, water and heat (for example dish-washing and oven gloves). Where used for commercial purposes, the same products were already covered by the directive.
The definitions and adapted conformity assessment procedures for made-to-measure and individually adapted PPE are new. These forms of PPE are thus placed on a clear legal footing.
The term "category" has been introduced. This term is already in general use; before now however, it was explained only in the PPE Guidelines. The definitions of the individual categories are formulated in simpler terms and are based upon the magnitude of the risk against which the PPE concerned is to provide protection. Certain risks have been added to Category III, as a result of which a number of additional types of PPE will in future be subject to the strictest conformity assessment procedure. The proposed regulation makes provision for changes to the assignment to categories by means of a delegated legislative instrument. Such changes will therefore no longer entail the entire protracted process of revision of the regulation.
In future, type-examination certificates are to be valid for a maximum of five years. The proposal also describes the procedure for extending the validity of a certificate, and sets out the minimum information that it must contain.
The declaration of conformity must in future be supplied with each individual item of PPE made available on the market. This requirement can be met by means of a "simplified declaration of conformity" comprising a single sentence and a reference to the web address at which the complete declaration of conformity can be found.
Only minor amendments have been made to the essential health and safety requirements. Besides editorial improvements, three requirements concerning protection against vibration, noise and non-ionizing radiation have been revised which in the past have proved to be impracticable.
Adaptation to the New Legislative Framework
In accordance with the "Internal Market Package" adopted in 2008, the Commission proposal has been adapted to the New Legislative Framework (See KANBrief 3/11) and contains elements that have now long been called for. These include definitions and obligations for manufacturers, importers and distributors, more comprehensive and specific conditions for the notification of conformity assessment bodies, and the conformity assessment modules, some of which have been amended. The existing procedures have served as a model as far as possible.
The proposal contains no provisions governing formal objection to a standard; since the beginning of 2013, this has been governed by Regulation (EU) No 1025/2012 on European standardisation. Nor does the proposal contain provisions concerning market surveillance, such as a safeguard clause against nonconforming products, since this is to be governed in future by the planned EU regulation on market surveillance.
Further schedule
The Commission proposal must now be debated in the European Parliament and the Council. Deliberations will however only be begun by the new parliament that is to be elected in 2014, and will not commence before the autumn of next year. The PPE Regulation is not therefore expected to be adopted before the beginning of 2016 at the earliest.
According to the Commission proposal, application of the regulation is to become binding two years after its publication. In addition, provision is made for a transitional period of one year in which products may be placed on the market in accordance with either the former directive or the new regulation. Type-examination certificates issued under the former directive may retain their validity for up to five years following expiration of the transitional period.