Executive Summary Sheet

Impact assessment on Proposal for a Regulation of the European Parliament and of the Council on laying down rules and procedures for compliance with and enforcement of Union harmonisation legislation on products

A. Need for action

Why? What is the problem being addressed?

The value of products subject to EU harmonised rules amounts to more than 2 400 billion euro per year representing 69% of the overall value of manufacturing products in the EU. The existence of non-compliant products exposes citizens to potentially dangerous products, puts the environment at risk and distorts competition. The root causes are limited knowledge of rules, low deterrence, and major inefficiencies in the enforcement systems. The problem is expected to increase due to growing online sales and imports from third countries.

What is this initiative expected to achieve?

This initiative aims to reduce the number of non-compliant products in the Single Market, by (1) Reinforcing cooperation procedures (2) Increasing operational enforcement capacity, improving efficiency and availability of resources; (3) Strengthening the enforcement toolbox; (4) Promoting compliance and accessibility of compliance information.

What is the added value of action at the EU level? 

Enforcement of Union harmonisation legislation is the responsibility of Member States that are constrained by jurisdictional boundaries. Coordination of activities is necessary to ensure consistent enforcement across the EU and efficiently tackle non-compliance.

B. Solutions

What legislative and non-legislative policy options have been considered? Is there a preferred choice or not? Why? 

The options considered are: (1) Baseline; (2) Improvement of existing tools and cooperation mechanisms; (3) in addition increased deterrence effect to enforcement tools and stepped up EU coordination and (4) further added-on centralised EU level enforcement in certain cases. The preferred option includes a mechanism for mutual assistance among authorities, an EU Product Compliance Network to coordinate, help implementing joint enforcement activities and peer review Member States' performance, common powers for authorities, more systematic publication of restrictive measures, recovery of control costs in case of non-compliant products and obligation of manufacturers to designate a person responsible for compliance information in the EU and an extended advice role of Product Contact Points, digital publication of compliance information and a web-portal for voluntary measures.

Who supports which option? 

Stakeholders concur on the need for much stronger coordination, more and efficient use of resources and more effective tools to improve the enforcement framework for controls within the Single Market and for imports into the EU.

C. Impacts of the preferred option

What are the benefits of the preferred option (if any, otherwise main ones)? 

The initiative would result in more effective enforcement against non-compliant products throughout the Single Market and more efficient checking of imports. Product users' would be better protected from undue environmental, public and occupational health and safety risks. Businesses would benefit from compliance assistance, a more level playing field and reduced unfair competition.

What are the costs of the preferred option (if any, otherwise main ones)? 

Some economic operators may face adjustments to provide compliance information digitally or appoint a responsible person in the EU. Costs to the Commission/EU budget would relate in particular to the establishment of an EU Product Compliance Network (€18 million per year). No negative environmental or social impacts are anticipated.

How will businesses, SMEs and micro-enterprises be affected?

The proposal would help businesses, including SMEs, reduce negative effects from unfair competition or inconsistencies.

Will there be significant impacts on national budgets and administrations? 

Member States would have to adjust to new procedures, but they would also save costs due to streamlined cooperation procedures.

Will there be other significant impacts? 

In the fine-tuning of national authority powers and enforcement measures, due respect for fundamental rights and the principles of legality and proportionality will need to be ensured.

D. Follow up

When will the policy be reviewed?

In addition to regular monitoring, an evaluation of the functioning of the new legislative framework is expected after around 5 years of implementation.