Who enforces EU Chemical Regulations? Have your productes been tested?

Europe has a tradition of rule-making with weak enforcement. This is changing rapidly. Not only are public authorities stepping up their enforcement powers and efforts, consumer and environmental organizations are playing an increasing role.

The issue has been illustrated in the past couple of years with thousands of toys being tested on the presence of dangerous chemicals and millions of them being withdrawn from the market.  It has also become more common  for competitors to analyze your products and tip-off enforcement officials. Now, industry associations are known to test products on the market, file complaints with the enforcement authorities and call upon them to better enforce the rules. The European Tyre and Rubber Manufacturer Association is just one of the recent examples in this regard.

The enforcement of Regulation EC/1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) lies with the competent authorities of the Member States. The European Chemicals Agency (ECHA) does not have any enforcement responsibility. However, ECHA hosts the Forum for Exchange of Information on Enforcement (the Forum) which aims to be a body for the exchange of information and coordination of enforcement activities related to chemicals legislation.

In March 2011, the Forum adopted two documents on the enforcement of the REACH Regulation as well as Regulation EC/1272/2008 on the Classification, Labelling and Packaging of substances and mixtures (the CLP Regulation). One document establishes common minimum criteria to be applied by Member States during the performance of REACH and CLP inspection activities, while the second document focuses on setting a framework and recommendations for the elaboration of national REACH and CLP enforcement strategies.

Even though both Regulations are directly applicable in all EU Member States without requiring any national transposition measures, Member States are required to set up their own national system for compliance monitoring and control, including inspection activities. The Forum enforcement documents highlight that national enforcement strategies should allow planned, structured, coordinated and consistent enforcement actions, involving all inspection bodies concerned. In this context the role of customs authorities is pointed out, considering the key role of importers under the REACH and CLP Regulations placing substances on their own, in mixtures or in articles on the EU market.

Member States should agree on the involvement of customs authorities as well as the appropriate information exchange methods with customs for an effective enforcement strategy. The aim should be that customs participate proactively (compliance checks during routine customs controls) and reactively (providing information during investigations) in the enforcement process. How co-operation with other enforcement authorities and customs is designed needs to be decided at the national level. However, as a general rule it is considered preferable to create a framework for the involvement of customs authorities. Until such a framework exists, mechanisms based on legal/formal documents, such as legislation, by-laws and orders or cooperation agreements are considered to be appropriate.

Initiatives related to enforcement are taken also by industry, mainly calling for a harmonised and strengthened enforcement approach by authorities. A recent example is the testing program initiated by the European Tyre and Rubber Manufacturer Association (ETRMA) concerning the prohibition to use polycyclic-aromatic hydrocarbons (PAHs) in tyres, as applicable under the REACH Regulation since 1 January 2010. Pursuant to the test results, 11% of all imported tyres manufactured after 1 January 2010 were found to be infringing the PAH restriction, while all tyres manufactured in the EU after this date complied with the REACH requirements. Considering the test results, ETRMA calls on public authorities to intensify their market surveillance activities in order to create a level playing field for competition. It is in the interest of industry that stronger and broader enforcement activities prevent free-riders from violating applicable rules, while the majority of the companies invest heavily to ensure conformity with applicable legislation. At the beginning of April 2011, the European Rapid Alert System for all dangerous consumer products, except food, pharmaceutical and medical devices (RAPEX) did not contain any entry related to the withdrawal of tyres from the European market which have been found as being in non-compliance with the PAH restriction under the REACH Regulation.  The RAPEX system does however already contain several examples of products being withdrawn from the market as a result of tests on the presence of for example Cadmium.

Have your products already been tested?  Do they meet EHS requirements?  Have you been able to control your supply chain to ensure there are no components or subcomponents that violate requirements in all markets?  To help you ensure product compliance, the Enhesa Global Product Stewardship practice has developed an EU Product Compliance Checklist (More Info) that will guide you through the myriad of requirements to help you verify and document compliance.  Enhesa can also carry out audits to ensure you are properly prepared to respond to enquiries from enforcement authorities.

Judit Beress

EU EHS Consultant


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