WOPCOM blog: Recent changes in PPE regulation, by Dr. Geert Böttger

Recent Changes in PPE-Regulation

The PPE-EU-Regulation 425/2016 is effective since April 21st, 2018. It substitutes EU-Directive 89/686/EEC, and tightens the business with Personal Protective Equipment (PPE) substantially. Many textile service companies still need clear information. Here is our brief.

The most important points:
(1) Direct law in EEC-member states
The new regulation is effective as direct national law in all EEC – member countries in order to harmonize health and safety requirements.
This change has been done, because the now repealed EU Directive 89/686/EEC needed to be transferred to the national laws. That process had caused – according to the EU – too many misunderstandings and too different national laws. EU wanted to achieve the same rules for production and distribution in the internal market.

(2) Effective for all economic operators dealing with PPE
The new regulation assigns to „all economic operators in the supply and distribution chain the  responsibility to take appropriate measures to ensure that they make available on the market only PPE which is in conformity with this regulation“ (§ 12 of introduction to 2016/425). This includes also
– online and distance selling
– new products, but also used PPE
– imported PPE from outside the EU
– textile service companies working with PPE.

(3) Obligation of Suppliers/Manufacturers
+ technical documentation, declaration of conformity, and the  information to whom the PPE has been distributed, need to be stored for 10 years
+ products have to be controlled (sample)
+ declaration of conformity needs to be tagged at PPE, or a download link has to be offered, which leads to the declaration for the product
+ all applied norms must be indicated exactly
+ all products have to have the producers or importer registered trade name or registered trade mark and the postal address
+ documentation of the complete value chain is mandatory to ensure traceability of PPE
+ an exact assessment of health and safety risks must be provided, which the PPE should protect for
+ Distributors and importers might be involved in market surveillance tasks carried out by the competent national authorities. They must provide all necessary information relating to the PPE concerned
+ if the PPE is not conform, the supplier has to inform market surveillance authorities and has to take appropriate actions

(4) Obligations of Trade and Textile Service Companies
Wholesalers, retailers and textile service companies need to involve themselves more under the directive
+ they need to check, if the producers or importers registered trade name or registered trade mark, the postal address and the CE mark are attached to the PPE
+ they have to check, if producer or importer have provided all necessary technical documents, manufacturers information and declaration of conformity. This check needs to be documented
+ Suppliers and buyers need to be known to help market surveillance authorities in case of need
+ all documents need to be stored for 10 years
+ in case of products, which are not conform, appropriate actions of correction need to be implemented and market authorities have to be informed

(5) Textile Services as Manufacturer
Basically Textile Services are viewed as distributors and providers of PPE. However, they adopt manufacturer – status and related obligations,
– if the economic operator places PPE on the market under his own name or trademark
– if the economic operator modifies a product in such a way that compliance with the requirements of this regulation may be affected. That can happen via repeated washing and refunctionalisation processes.
(6) Prolongued EC type-examination certificates
EC type-examination certificates based on the old 89/686/EEC remain valid until 21 April 2023 unless they expire before that date. Thus bottlenecks at certification bodies and time pressure in safety issues should be avoided.

Complete text in your language
If you want to study EU Regulation 2016/425 in your language, go to:
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32016R0425.

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