Has Europe's Reach Exceeded Its Grasp (With apologies to Robert Browning)
April 18, 2007
In an effort to protect health and the environment, the Council of the European Union (hereinafter “EU”) adopted on December 18, 2006 a regulation called the “Registration, Evaluation, Authorisation and Restriction of Chemicals” known by the acronym REACH. Regulation (EC) No. 1907/2006. This regulation is perceived by the Europeans as the most important regulation in the past 20 years.
Businesses that are subject to REACH must demonstrate that chemicals used in their products are safe and that they are encouraged to seek out safer chemicals and to eliminate hazardous ones. The burden is on the businesses to make the demonstration. The Regulations do not apply to certain materials handled by other regulations such as radioactive substances, wastes, food stuffs or medicines, articles in transit through but not staying in the EU. There also is a research and development exemption.
As for the remaining substances (estimated to be over 30,000 substances), any producer, importer has to register any substance contained in their products if the substance exceeds more than one ton a year and is intended to be released in usage in the EU.
REACH reaches back to products in use that have “substances of very high concern” contained in them. Despite past usage, the producer or importer must have authorization from the European Chemicals Agency (ECA) to use these products. This is a new organization yet to be constituted. Even if this body grants authorization, it does not evergreen the authorization. Undoubtedly, the authorization will be scrutinized each year or such other renewal period as the ECA provides. The ECA will be in place by June 1, 2007 and be responsible to evaluate the registrations and suspicious chemical. It will provide a database so that all employees, consumers, other businesses and professionals can obtain information. There is an emphasis on data sharing and avoiding unnecessary testing. This will create problems of confidentiality.
Registration is the key component. The business registering chemical substances, that means manufacturers and importers, complete a technical dossier. The dossier is a chemical safety report and supply safety data sheet. These are designed to be more complex than what in the United States is known as Material Safety Data Sheets.
The ECA then engages in evaluation of the dossiers. The evaluation is to weed out unnecessary testing and poor testing. One object is to reduce any animal testing. There will be compliance testing based on the evaluation of the dossiers. The Evaluation is also to isolate and eliminate out substances of great concern.
The third component of the acronym is authorization. Some substances cannot be banned. They are suspicious or known chemicals that are of very high concern. These substances require authorization before they can be used. For the most part these are substances that are carcinogenic, teratogenic, or mutagenic. They are also substances that are known to cause harm to the environment. Once authorized however the substances are subject to periodic review. The goal is to eliminate them though technological innovation and economically viable alternatives.
In the meantime, these chemicals are to be restricted, which is the fourth component of the acronym. They are to be managed by the ECA on a European wide basis. These substances, although not banned, are to be highly regulated.
The Regulations reach both downstream and upstream parties. There is a duty to supply information up the supply chain. Thus, if a company is anywhere in the supply chain, anywhere in the world, it has to communicate to the next actor or distributor up the supply chain the nature of the substances to be used in the EU. Similarly, there is a duty to communicate information down the supply chain even if a safety data sheet is not required. Certainly those who directly ship, sell products in the EU must comply but so to will producers who do not directly ship or sell products to the EU but find themselves in a supply chain.
The ECA will be headquartered in Helsinki, Finland.