Latest news about new regulation (EU) 2016/425

By 2018-10-22Blog, PPE規制

In original regulation, Article 47 has stated the transition requirement as following:

Article 47 Transitional provisions

1. Without prejudice to paragraph 2, Member States shall not impede the making available on the market of products covered  by  Directive  89/686/EEC  which  are  in  conformity  with  that  Directive  and  which were  placed  on  the  market before 21 April 2019.

2. EC type-examination certificates and approval decisions issued under Directive 89/686/EEC shall remain valid until 21 April 2023 unless they expire before that date.

On 2017/12/7, the EU Commission published Regulation (EU) 2016/425 on personal protective equipment Guidance document on the implementation of Article 47 on transitional provisions. This document stated transitional period for PPE of 1 year (2018/4/21 to 2019/4/21 ) where both, the old Directive and the new Regulation, are applicable. Between 2019/4/21 to 2023/4/21, PPE stock by old EC-type may be still placed on the market*(with exception). After 2023/4/21, old EC-Type certificated are invalid.

However, EU Commission document also stated, this approach is not applicable in the following cases:

•One or several applicable essential health and safety requirement(s) in the Regulation has/have changed on substance to the extent that a higher level of protection than the Directive is required. In this case a certificate issued under the PPE Directive cannot be used to demonstrate compliance with the Regulation and an EU type-examination certificate under the Regulation must be issued;

•The design and/or manufacture of the PPE has changed since the last EC type-examination;

•The generally acknowledged state of the art which is reflected by European harmonized standards has changed (updated versions with significant changes on safety clauses, withdrawal of current versions, etc.) and therefore it may imply that the product may not be compliant.

Our products will strictly follow EU 2016/425 regulation and do not belong to the three exceptions mentioned above so far.  We keep working closely and will make sure 100% follow the new EU regulation timely.  You are safe with us! 

The latest list of harmonized standards can be found at following link.