In the near future, substances in articles produced within the EU or imported into the EU will be met by new regulations. This situation will arise when the new EU regulation on chemicals, REACH (Registration, Evaluation, Authorisation and restriction of CHemicals) is adopted as expected in the spring of 2007. In two cases, producers or importers of articles may need to submit information to the new EU Chemicals Agency in Helsinki, ie:
- In the case of an intended release of a substance from the article
- In case, the article contains one or more very problematic substances
“Very problematic substances” are defined in REACH as substances of very high concern to human health or the environment.
In the first case, a registration to the Agency of the substance intentionally released is triggered by the total amount of this substance in all of the producer’s/importer’s articles.
In the second case, ie when a very problematic substance is present in the articles, a notification to the Agency may be required. Here, the triggering parameters are the total amount of the substance in all of the producer’s/importer’s articles and the concentration of the substance in the article. The amount of data required for a notification is much lower than that required for the registration.
The new regulation will make heavy demands on the article producers and article importers regarding their knowledge of the content of substances in their articles. This is explained in the Technical Guidance Document on fulfilling the requirements for substances in articles, which was developed by a consortium headed by DHI within REACH Implementation Project 3.8, sponsored by the European Commission.
In general, articles are not delivered with safety data sheets or other information. However, with REACH, producers and importers of articles are required to deliver information to their recipients if an article contains very problematic substances at concentrations above 0.1% (w/w).
For more information, please contact Margrethe Winther-Nielsen (mwn@dhigroup.com) or Anne Rathmann Pedersen (arp@dhigroup.com)