Hong Kong’s exporting community should be alerted to an impending deadline, 30 November 2009, for certain imports of chemicals, preparations and chemical-containing articles entering the EU. The REACH Regulation requires that for any such imports to continue smoothly and freely into the EU, importers (or so-called Only Representatives of manufacturer-exporters outside the EU) had to pre-register the chemical substances being imported by a now-long-passed deadline (1 December 2008). The only allowed exception to this has been that of “first-time” manufacturers or importers.

Despite the complex intricacies of the REACH Regulation, it is well-known by now that pre-registration is the process via which a potential registrant of a phase-in substance submits certain minimal required information to the European Chemicals Agency (ECHA), which consequently allows the entity to benefit from the transitional regime before full-fledged registration. The pre-registration period ended on 1 December 2008. However, potential registrants who manufacture or import, for the first time, a phase-in substance in quantities of one tonne or more per year after 1 December 2008, can submit a late pre-registration, provided they do so:

• at the latest 6 months after manufacturing or importing a substance above the 1 tonne threshold per year; and
• at least 12 months before the relevant transitional deadline for registration.

Hong Kong businesses may know that late pre-registration does not apply to companies that should have, but failed to, meet the pre-registration deadline. These companies cannot continue producing or importing the substance until they have submitted a full registration dossier for the relevant tonnage. First time pre-registrants will need to pre-register any substance one at a time with the online pre-registration functionality. Late pre-registrations can only be submitted via the REACH-IT portal. As a late pre-registrant, an entity must sign up in REACH-IT to create an account and be able to submit their dossier (details can be obtained from the ECHA website, see link below).

The final deadline for late pre-registration is 30 November 2009 for potential registrants who need to  register their phase-in substances by 30 November 2010. A phase-in substance needs to be registered by 30 November 2010 if it is:

• manufactured in or imported into the EU in quantities of 1,000 tonnes or more per year;
• classified as carcinogenic, mutagenic or toxic to reproduction (category 1 or 2) and manufactured in or imported into the EU, in quantities of 1 tonne or more per year;
• classified as very toxic to aquatic organisms which may cause long-term adverse effects in the aquatic environment (R50/53) and manufactured in or imported into the EU in quantities reaching 100 tonnes or more per year.

For further information on first time imports, Hong Kong businesses should access the following:

http://echa.europa.eu/reachit/pre-registration-it_en.asp

The date of 30 November 2009 is a deadline for another activity under REACH. It applies to Downstream Users (DUs) in the Community, of chemical substances, who need to inform their suppliers (e.g., EU importers) of the use they make of the substance. The deadline of 30 November 2009 applies only if the substance needs to be registered before 1 December 2010 (which would be the case in the three bullet-pointed situations described above).

As a user of chemicals, the DU should inform its suppliers about its use of a substance if it wants the supplier to lay down the use in relation to the registration of the substance concerned. The advantage of communicating its use in time to the supplier is that the DU’s conditions of use are then normally covered by the supplier’s Exposure Scenario. The registrant of the substance will have to take account of the use in preparing the Chemical Safety Assessment. The DU can then expect its use to be an identified use and have an Exposure Scenario covering its conditions of use, unless the registrant cannot support the use. If the registrant cannot support the DU’s use for reasons of protection of human health or the environment, both the DU and ECHA need to be notified.

Hong Kong businesses’ DUs in the EU should note that if they do not communicate their use, and it is not covered by their supplier’s Exposure Scenarios, they will eventually need to prepare a Chemical Safety Assessment themselves, once the substance has been registered. This can be extremely burdensome, time-consuming and costly. The DU is thus advised to provide its information in writing to its supplier on both the use and the conditions under which the substance is used.

For more information on DUs and the information to be provided to their suppliers, Hong Kong businesses may like to access the following:

REACH Guidance for Downstream Users (chapters 4, 6, 7 and 8):

http://guidance.echa.europa.eu/docs/guidance_document/du_en.htm?time=1254330774

Guidance on information requirements and chemical safety assessment Chapter R.12: Use descriptor system:

http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_r12_en.pdf

REACH Fact Sheet - Downstream Users – How To Make Uses Known to Suppliers:

http://echa.europa.eu/doc/reach/reach_factsheet_du_en.pdf