Directives, Regulations and the CE mark

PPE Directive/New Regulation

Products designed and manufactured to protect the wearer against health and life hazards are Personal Protective Equipment (PPE). To harmonize product requirements and to minimize trade barriers throughout the European Union, the products are regulated by Council directive 89/686/EEC. The directive contains essential health and safety requirements including assessment procedures for a product to enter the market and therefore eligible to carry the CE mark. This directive will be replaced by Regulation 2016/425. A regulation, as opposed to a directive, does not need to be transposed through national parliaments to take effect. The highlights and practical implication and timeline for this new regulation to take effect is as follows:

  • April 2016: New regulation is published
  • April 2018: Old directive is withdrawn
  • April 2018: New regulation is taking effect
  • April 2019: All manufacturer’s instructions must be to new regulation
  • April 2023: All undated certificates previously issued by notified bodies are invalid.

Changing needs

All products classified as PPE must be CE marked, as a testimony from the manufacturer that the product fulfils all of the applicable health and safety requirements in the PPE directive. The quickest way to CE mark a product is to certify it against a standard. At the moment there are established standards and products in the market, but the needs and uses for visibility products are changing and so must standards and product solutions. The current trend is to merge fashion and visibility needs. Often, the borderline between what is a fashion product and what is a safety product is not clear. The new regulation is attempting to guide us in distinguishing between decorative and protective equipment, thereby drawing the line between design and safety. It is now up to standard makers to make understandable standards that can be used by manufacturers to place usable CE marked products in the market. Reflectil is taking an active role in the European standardisation groups to contribute to this important social need.