In December last year, the European Commission published a new “Goods Package” – proposals to significantly reform aspects of product regulation in the EU by 2020. The proposals mainly focus on aspects of enforcement of existing rules.  This is important because, whilst European product regulation is amongst the strictest in the world, the requirements are often not strictly enforced by the authorities.   These new proposals promise to change that approach.

In a nutshell, on the one hand the proposals bring some good news, in that they should, if implemented effectively, help keep “rogue” traders out of the market and ensure a more level playing field in Europe for legitimate market participants.  There should also be reduced scope for individual member states to restrict products by imposing national requirements affecting products that are being lawfully sold in other parts of the EU. But these benefits come at a price. For certain products, there will be new requirements that will need to be observed, which will involve expense.  And there is a raft of provisions that will significantly enhance enforcement activity by market surveillance authorities throughout the EU, and which will increase the risks associated with such activity.

To give you a flavour of what is coming down the line, some of the key provisions include:

  • A new requirement that a product can be made available to the EU market only if there is a designated “person responsible” in the EU.  This mainly affects direct sales from outside the EU.  However, it won’t affect cosmetic products, since an equivalent requirement already exists under the Cosmetics Regulation.
  • Manufacturers must identify on their website the applicable “person responsible” for all products made available to the EU.  Also the “person responsible” must be identified on, or with, the product.
  • Declarations of Conformity must be available on the manufacturer’s website.
  • Companies can enter into “partnerships” with national market surveillance authorities.  This may bring some benefits if an authority in another country seeks to take action with which the company disagrees.  It also has risks.
  • There will be a new online portal to publish details of voluntary corrective actions for products.
  • Market surveillance authorities to establish procedures for monitoring risks and following up with companies on safety risks and corrective actions.
  • Wider requirements for market surveillance authorities to notify the European Commission of steps they take to deal with dangerous products.
  • More emphasis on making available to the public information about actions taken by authorities to deal with unsafe products.
  • More prescriptive scope of powers of authorities to investigate and enforce product safety rules.
  • Authorities can seize samples free of charge.
  • Authorities can take measures to temporarily suspend websites.
  • There will be the establishment or designation of Union testing facilities.
  • Enforcement costs will be recoverable from companies.
  • It encourages increased co-operation and information-sharing between national authorities.
  • Product declared non-compliant in one country will be presumed non-compliant in others.
  • Increased powers and responsibilities for customs authorities.
  • Enhanced information and communication system between the Commission and national authorities.
  • Specific provisions for co-operation with product safety agencies internationally.
  • New criteria for assessing penalties for breaches.
  • A new concept of a manufacturer’s “Mutual Recognition Declaration” to help avoid national restrictions on goods.
  • Streamlined procedures for resolving disputes over nationally-imposed restrictions.

These proposals still need to continue through the EU legislative process, so some aspects may be subject to change.  The current suggestion is that this takes effect from 1 January 2020.  The full text and further information can be found here:

These proposals will be a game-changer for product safety regulation in the EU.   Given the breadth, and the underlying sentiments, some aspects are likely to start to be implemented and take effect even in advance of formal adoption of the Regulations, especially on the enforcement front.

Posted by Cooley