REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the exercise of the power to adopt delegated acts conferred on the Commission pursuant to Regulation (EU) 2016/425 of the European Parliament and of the Council on personal protective equipment
Date: 2023-04-14
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: EU act, European Commission, delegated legislation, free movement of goods, proposal (EU), protective equipment, safety standard

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  EN 

   EUROPEAN COMMISSION  Brussels, 14.4.2023  COM(2023) 196 final  REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the exercise of the power to adopt delegated acts conferred on the Commission  pursuant to Regulation (EU) 2016/425 of the European Parliament and of the Council on personal protective equipment  
 
 
REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE 
COUNCIL 

on the exercise of the power to adopt delegated acts conferred on the Commission pursuant to 
Regulation (EU) 2016/425 of the European Parliament and of the Council on personal protective 
equipment 

1.  INTRODUCTION 

Regulation (EU) 2016/4251 lays down requirements for the design and manufacture of personal protective 
equipment (PPE) to ensure the protection of the health and safety of users and establish rules on the free 
movement of PPE in the Union. 

To  take  into account technical  progress  and  knowledge  or  new  scientific  evidence,  Article 42(1) of  the 
Regulation empowers the Commission to adopt delegated acts to amend Annex I by reclassifying the risk 
against which PPE is intended to protect users, moving it from one category to another. 

2.  LEGAL BASIS 

This  report  is  required  under  Article  43(2)  of  Regulation  (EU)  2016/425.  Pursuant  to  that  article,  the 
power to adopt delegated acts is conferred on the Commission for a period of 5 years from 21 April 2018, 
and the Commission is required to  draw up a report on the delegation of power no later than  9 months 
before the end of every 5 years. 

Article 43(2) of the Regulation states that the delegation of power shall be tacitly extended for periods of 
identical duration, unless the European Parliament or the Council opposes their extension no later than 3 
months before the end of each period. 

3.  EXERCICE OF THE DELEGATION 

Since the entry into force of Regulation (EU) 2016/425, the Commission has not used the empowerment. 
No delegated act has been adopted yet. 

The PPE risk categories listed in Annex I to the Regulation are still up to date. However, the reasons, for 
which the co-legislators conferred the power to adopt delegated acts on the Commission, remain valid and 
the Commission may need to use the empowerment in the future.  

4.  CONCLUSION 

The  Commission  believes that,  although  to  date  it  has  not  adopted  any  delegated  act,  the  delegation of 
power as stated in Article 42(1) of Regulation (EU) 2016/425 should be tacitly extended for 5 years, in 
accordance with Article 43(2) of the Regulation. 

The need to reclassify the risks by moving them from one category to another may arise in the future. It is 
important  to  maintain  the  necessary  flexibility  in  the  legal  framework,  to  take  into  account  technical 
progress and knowledge or new scientific evidence in order to protect the health and safety of users.   

The Commission invites the European Parliament and the Council to take note of this report. 

1 Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective 
equipment and repealing Council Directive 89/686/EEC (OJ L 81, 31.3.2016, p. 51) 

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