The European Chemicals Agency has released guidelines for the pre-registration of phase-in chemicals in the EU, under REACH. These will be important for the Hong Kong chemicals industry selling to the EU, because after the REACH requirements for pre-registration and registration enter into effect, the manufacture and import of chemicals will only be allowed if the chemical is properly registered. This includes the importation of individual substances, substances in preparations, and substances in articles where the release of the substance is intended. The pre-registration period for phase-in chemicals will begin on 1 June 2008 and end on 1 December 2008. Phase-in chemicals comprise the majority of chemicals traded in the EU, and are said to number more than 100,000.

Of particular note for the Hong Kong chemicals industry, companies manufacturing chemicals outside the EU will not be able to register their chemicals directly, but will have to depend on their importers in the EU to do so, or else be required to designate an "only representative" within the EU to register the chemicals. This must be a natural or legal person who is established within the EU and, among other matters, has knowledge and experience in handling chemicals and the information related to them.

Four sections of information will be required for pre-registration of phase-in chemical substances. The first section will be the name of the substance identified by the IUPAC-names, EINECS, CAS or other identity code. Second, the entity who is registering must provide the name of the company who is manufacturing or importing the chemical, the company's address and the name of a contact person. Each manufacturing or importing entity must register independently even if they are importing the same substance as another entity who has been registered. Third, the entity must provide the registration deadline for its pre-registered chemicals and the anticipated tonnage of the chemical import. Fourth, the entity must give the IUPAC-name of other substances with substance information relevant to the pre-registered chemical. This is a way of indicating which data can be shared by read-across, (quantitative) structure-activity relationships ((Q)SARs)) and grouping of substances.

If a company fails to pre-register, it will not be allowed to place on the market its phase-in chemicals after 1 December 2008 without completing the full registration process. If the company does pre-register, the registration deadline will be extended to 30 November 2010, 31 May 2013, or 31 May 2018, depending on the nature and quantity of the chemical. Therefore, Hong Kong sellers should be warned that failure to pre-register may result in interruptions to supply chains.

As the preparation of phase-in substance dossiers are likely to be a lengthy, time-consuming and expensive process, pre-registration will provide companies with more time to obtain and compile the information necessary to complete the registration.

There are a couple of other advantages which pre-registration provides. First, all pre-registered companies will be placed in a Substance Information Exchange Forum (SIEF) for each substance, which will provide a convenient forum for all registrants to share the chemical data necessary to complete their registration dossiers. Through this data sharing network, it is expected that companies will be able to obtain chemical profile information more quickly and easily, at less cost. Additionally, pre-registration is free and carries with it no obligations to actually produce or import any chemicals, or carry out full-fledged registration in the future.

Among the steps a registrant should take to prepare for pre-registration are, making an inventory of the products it manufactures or imports into the EU and identifying if they are single substances, preparations (a solution containing more than one distinct substance), or articles that contain substances which will be foreseeably released from the articles. A registrant should also check if the substance it wishes to pre-register is exempt from registration (e.g., by checking the REACH Regulation's Annexes IV and V, or if the substance has another special status under REACH).

A company can only pre-register electronically through the REACH-IT portal on the ECHA website. After entering the pre-registration web-page there will be two options on how to submit a pre-registration form. First, a company can fill out the form directly available on the website. Second, a company can use the specifications found on the IUCLID 5 section of the website to create XML files which can then be uploaded to the pre-registration website. ECHA designed this later option for companies which have many substances to pre-register as it allows companies to consolidate many pre-registration forms into one electronic file.

Timely pre-registration is strongly encouraged because there are very few exceptions to the 1 December 2008 pre-registration deadline. For more information visit the REACH website at http://reach.jrc.it or the European Chemicals Agency website at http://echa.europa.eu.