IMPACT OF THE NEW EU PERSONAL PROTECTIVE EQUIPMENT REGULATION 21 April 2018 marks the end of the two-year preparation period for the implementation of the new PPE Regulation (EU) 2016/425 and the beginning of the one-year transition period for manufacturers. Whereas the old PPE Directive 89/686/EEC had to be written into national law by all member states, the new regulation is directly applicable throughout the European Economic Area. Changes include the re-categorisation of certain types of equipment, new requirements for documentation, and procedures that better reflect the existing best practices in the business for many PPE manufacturers. What these changes mean for the end user will be discussed below. CHANGES IN SCOPE Regulation (EU) 2016/425 refers to PPE as ‘equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person’s health or safety;’ as well as spare parts and connexion systems. Certain types of PPE do not fall under the regulation, such as military and police equipment, as well as PPE for use on ships and aircraft. As a new addition, equipment designed for private use to protect against heat, such as oven mitts, is now considered PPE. STREAMLINED DOCUMENTATION Whereas the previous directive primarily focused on the responsibilities of manufacturers, the new regulation increases the obligations of all economic operators involved in placing a product on the market. This is partly due to the rise of e-commerce and the emergence of new types of actors and distribution modes. For instance, importers and distributors will be held responsible for placing non-compliant PPE on the market and are obliged to secure all the necessary documentation from the manufacturer. The EU Declaration of Conformity must now be attached to the product either as a physical copy or through a web link in addition to the instruction manual and safety information. IMPROVED TRACEABILITY With the new regulation, products must include an indication of the name and postal address of the economic operator that placed the product on the market, which, in most cases, would be the manufacturer and/or importer. If it is impossible to print the name and postal address on a piece of equipment due to limitations in size and material, it may be printed on the packaging or in an enclosed document. RE-CLASSIFIED HEARING PROTECTION Hearing protection equipment, such as ear muffs and plugs, will be re-classified from Category II to Category III, which designates harmful noise as risk that may cause irreversible damage to the user’s health. This sends a strong signal from a legislative standpoint on the severity of harmful noise in the workplace and the necessity for reliable protection. Category III equipment requires either continuous product checks by a notified body (Annex VII, Module C2) or an audit of the manufacturer’s production and testing procedures (Annex VIII, Module D). In this case, the end user will benefit from the more demanding quality controls when purchasing hearing protection. CONCLUSION The obligations placed on all economic operators to ensure traceability, documentation, and to cooperate with market surveillance authorities to identify uncompliant equipment should help increase consumer trust in the European PPE market. This also emphasises the importance of choosing manufacturers and distributors that are capable of adhering to the new demands. As a manufacturer and distributor of PPE, ICM strictly adheres to all industry standards and international legislation. For questions regarding what the new regulation means for you and your equipment, please contact your ICM consultant. 2 31.3.2016 L 81/51 31.3.2016 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