The EU REACH 1907/2006/EC was adopted on 18th December 2006, and went into effect on 1st June 2007. REACH first primary regulatory impact started to take effect mid-2008.

Under REACH, most chemicals, both new and existing, which are manufactured or imported into Europe in quantities exceeding 1 metric ton per year, will need to be registered with the European Chemicals Agency.

This registration obligation applies to substances on their own or in preparations, as well as substances in articles, if intended to be released from the article under normal or reasonably foreseeable conditions of use. Only substances have to be registered; preparations or articles as such do not.

If you are manufacturing substance in the EU, or importing substances into the EU then it is very likely that you must develop a REACH strategy for your business.

If you are a non-EU manufacturer of substances, preparations, or articles containing substances required to be registered, REACH offers you the possibility to nominate an “Only Representative” located within the EU to carry out the registration of the substance that you export to EU. The Only Representative will have to comply with all the registration obligations of importers.

The registration obligation falls on manufacturers and importers, but downstream users will also need to ensure that their specific uses are registered. The amount of information and data needed for registration will depend on the quantities or tonnage of the chemicals, with more data needed at higher tonnage levels.

The “registration dossier” is the set of information submitted electronically for each particular substance. It consists of a technical dossier containing a set of information about:

• the identity of the manufacturer/importer;
• the identity of the substance and information on the manufacture and use of the substance;
• the classification and labeling of the substance;
• guidance on its safe use; robust study summaries of the information on the intrinsic properties of the substance; and proposals for further testing on vertebrate animals, if relevant;
• for substances registered in quantities between 1 and 10 tones, the technical dossier shall also contain exposure related information for the substance (main use categories, type of uses, significant routes of exposure) in order to qualify for reduced data requirements at that tonnage.

Note that this background information is basic information. More information can be found in the Guidances and the FAQs of the European Chemicals Agency.

REACH Timetable Companies will have little time to comply with the core REACH obligations. New chemicals are subject to the Registration provisions of REACH since 1st June 2008. For existing chemicals, there was a pre-registration phase which extended from 1st June 2008 to 1st December 2008. Companies that manufacture or import an existing substance in quantities of 1 ton/year or more, which have failed to pre-register their chemicals during that six months window of opportunity have lost the special registration benefits afforded to existing chemicals.

There was the possibility to pre-register during this period based on prospective volumes if the 1 ton/year threshold has not been reached before 1st December 2008 and the opportunity to pre-register late when the 1 ton threshold is reached according to certain conditions. The Registration dossiers for pre-registered existing chemicals are due in three phases of 3.5, 6, and 11 years after entry into force, with high volume and high risk chemicals required to be registered first.

The Chemical Safety Report will need to be drafted as part of the Registration process for substances at the 10 tons/year level.