The Footwear Technology Center of La Rioja, CTCR, has received a large representation of entrepreneurs from the footwear safety sector, interested in knowing the new EU Regulation 2016/425 on applicable requirements for the marketing of PPE, which is intended to replace the existing Directive 89/686/EEC and will bring important changes to the sector. Thus, CTCR and ASEPAL, the association that groups the entire business community related to the prevention of occupational risks, has cited both manufacturers and distributors of EPI to bring the modifications and alterations that affect our industry. This will make it possible to take the best possible decisions before the entry into force of the new PPE Regulation in 2018.
Last March was published the new EU Regulation 2016/425 on the requirements applicable to the commercialisation of Personal Protective Equipment, PPE, whose modifications will be more specific in some aspects that until now were contemplated in other legislations.
In summary, some of the main changes that the new regulation implies are shown below:
1. Extension of the scope to products of private use that protect against heat, humidity and water. In the sort of risk categories, the Regulation will consider as PPE category III those intended for protection against harmful biological agents, drowning, chain sawing, high pressure jets, noises and bullet wounds.
2. Definition of the responsibilities of all economic operators, including distributors and importers. The manufacturer must therefore carry out an assessment against which PPE is intended to protect, as well as take into account both the foreseen uses of PPE and foreseeable uses. In addition, importers should ensure that the PPE manufacturer has implemented the conformity assessment procedures set out in the Regulation and that the PPE has associated mandatory documentation. Likewise, distributors should ensure that the PPE carries the CE marking and is accompanied by documentation such as the EU declaration of conformity and the information leaflet.
3. With regard to documentary requirements, the declaration of conformity must be delivered with each PPE or must be accessible for download via the internet at an address to be indicated in the information leaflet.
4. The establishment of a traceability of PPE will be reinforced in the regulation with the obligation to identify the equipment with a number of type, lot or series.
5. The regulation stipulates specific market surveillance measures, detailing performance procedures for PPE conforming to the Regulation that present a risk or for PPE that present some type of formal non-compliance with regard to the documentation with which the equipment should be delivered.
6. With regard to the validity of the certificates, it is established that Type-EU certificates (new name of EC type-certificates) will be valid for a maximum of 5 years, being defined a simplified procedure for the revision of certificates in the absence of changes, either in the equipment or in the state of the art.
Finally, the Regulation provides that Directive 89/686/EEC is to be repealed on April 21st 2018, when products certified under the new Regulation may be put on the market. However, until April 21st April products certified under the previous Directive 89/686/EEC may continue to be placed on the market. After this date, only certified products according to the new Regulation may be placed on the market.
These deadlines and changes will not affect products already on the market and placed on the market in accordance with Directive 89/686/EEC, as their certificates will remain valid until April 21st 2023.
Therefore, during these years ASEPAL must work together with the Administrations, Notified Bodies and other involved parties to act as a bridge between the sector of manufacturers and distributors of Personal Protective Equipment and the authorities and bodies responsible for implementing the new legislation.
ASEPAL, as it did during the 90's with the birth and implementation of RD 1407/1992, faces this process of preparation, implementation and consolidation of this new regulation, which will surely improve the conditions in which the Personal Protective Equipments are put on the market.