Introduction
Assessment
Results
Comment
Towards the end of 2011, the European Union's Forum for Exchange of Information on Enforcement published a facts report on the Coordinated Forum REACH Enforcement Project. The report covers specific aspects of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation, which will be of particular relevance to companies that are concerned with REACH compliance: namely, registration, pre-registration and the provision of appropriate safety data sheets. The report covers the period from May 2010 to April 2011.
REACH requires all companies manufacturing or importing chemical substances into the European Union above certain quantities to register those substances with the European Chemicals Agency (ECHA). The latter, in turn, has the duty to evaluate the safety of chemical substances before they can be marketed within the European Union.
Phase 1
The first phase of the enforcement assessment was performed from May to December 2009, with 25 member states participating and almost 1,600 companies being inspected. The aim of the project was to verify the compliance of importers and manufacturers (or only representatives of non-EU manufacturers) with the REACH obligations on pre-registration, registration and safety data sheets.
Phase 2
The follow-up phase was carried out in 19 countries from May 2010 to April 2011, and was guided by a working group which issued a project manual with guidance and recommendations for the benefit of inspectors. In participating countries, national coordinators were appointed who – following training by the ECHA at the beginning of the project in April 2009 – were responsible for training inspectors in their own countries. The report presents the results of the project, but does not include conclusions and recommendations (it is expected that these latter items will be published at a later date).
A total of 791 inspections were carried out in the 19 participating countries, including the largest EU member states (ie, Germany, France, the United Kingdom, Spain and Italy). The types of company inspected included importers and manufacturers of items commonly sold (eg, chemicals, chemical products and preparations, rubber and plastic products and fabricated metal products), as well as companies within the wholesale and retail trade. From among the 1,600 companies inspected, 278 were importers and 449 were manufacturers.
In 23 cases no pre-registration or registration had been submitted, and in nine cases the content of the pre-registration was incorrect. Therefore, the total number of non-compliant cases regarding the registration obligation was 32. In 86 inspections the inspected company was deemed to be a first-time manufacturer or importer, and was therefore entitled to benefit from late pre-registration.
As for the safety data sheet obligations, 623 of the visited companies possessed the required safety data sheets. For 67 companies, the required safety data sheet was unavailable or only partly available. In total, 1,969 products were checked; of these, 379 safety data sheets were incorrect.
Overall, non-compliance was found in 20% of the companies inspected. The measures employed against these companies included:
- blame and shame (ie, publicising the wrongdoing) in two cases;
- a letter of appeal in 36 cases;
- an administrative order in 42 cases;
- a fine in six cases;
- a criminal complaint in three cases; and
- other measures (eg, written advice, additional information requests) in 108 cases.
The results were felt to be comparable with those of the same project carried out in 2009, albeit with only half the number of inspections this time around. The percentage of non-compliance for this assessment was slightly less (20%) than in the initial project (24%), which is viewed as a welcome improvement.
In light of these findings, companies may deem it best to continue their efforts to ensure that they are operating in full conformity with the provisions of REACH, and should also keep an eye out for the forthcoming conclusions and recommendations of the report, which may provide useful guidance.
For further information on this topic please contact Reshad Forbes at Van Bael & Bellis by telephone (+32 2 647 73 50), fax (+32 2 640 64 99) or email ([email protected]).