In a fact sheet dated Apr. 24, 2009, the European Chemicals Agency (ECHA) reminded REACH preregistrants that it is urgent to become involved in SIEF activities as soon as possible since registrations are extremely tight, considering the amount of test data that needs to be provided with the registration dossiers; the first deadline is Dec. 1, 2010. Additionally, it is important to consider that the REACH provisions are new and that the SIEF processes are being performed for the first time. As such, it may take longer than previewed for the SIEF members to agree on critical issues.
A paramount point to consider, which the ECHA reminds potential registrants, is that deadlines for the submission of registrations are laid down in the REACH regulation. Therefore, ECHA does not have the power to change these. This fact clearly negates the question sometimes raised by the industry asking whether there can be an extension in registration deadlines due to constraints imposed by the current economy. According to the law, if a preregistrant does not meet the appropriate deadline and does not have a valid registration by that time, production or importation must cease.
The purpose of a Substance Information Exchange Forum (SIEF) and recommendations of how to get started were given in the March REACH Update titled "SIEF Activities for an Impending Deadline." This report also noted that SIEF formation processes had led to enormous e-mail traffic imposed on preregistrants. ECHA now describes difficulties in starting some SIEFs. The agency sees the major challenges as being related to inactive or non-responding SIEF formation facilitators (SFF), the lack of response from potential SIEF members, and the determination of whether to split or merge SIEFs.
SIEFs are managed by the members and are operated independent of the agency. However, due to challenges that have arisen, the ECHA offers support for the formation of SIEFS with this fact sheet, since the success of the SIEFs is crucial for the REACH processes. In this sheet, ECHA makes the following recommendations, among others:
• Where the current SFF is not working or is using the pre-SIEF as an opportunity to earn money, SIEF members should request the SFF to give up the role.
• SIEF members are free to work around the SFF, using their own information text field on the pre-SIEF page in REACH-IT to post comments or to comment via their own Web site.
• When a company does not respond to an e-mail, SIEF members should try sending an e-mail again; if the e-mail bounces back, then sending a fax is recommended.
• If there is no response, there should be no further need to contact them; however, the actions taken should be documented.
• The XML file of preregistrants should be downloaded at regular intervals to see whether any changes in contact details were made.
• It should be noted that communications could be filtered out as spam, and SIEF members should create a newsletter or Web site to document formation and progress.
The essential point is that, having made reasonable attempts to give SIEF members the opportunities to contribute actively, those who do choose to be active also have a chance to make the SIEF deliver.
This author wishes to reiterate the importance for potential registrants to get started immediately since the already immense workload will certainly be intensified by these ECHA suggestions. The total workload needed is unforeseeable, as is the time that will be needed for fulfilling all requirements. ECHA recognizes that this is a new process, that other issues are likely to arise, and that further discussion may be needed.
• ECHA appeals preregistrants to get started in SIEFs immediately, since registration deadlines are narrow.
• Additionally, the SIEF process length is unforeseeable due to the inexperience with REACH provisions.
• Registration deadlines will not be extended for any reason because they are laid down by law.
• The ECHA describes existing challenges in getting some SIEFs started.
• ECHA suggestions have been developed to assist registrants in overcoming SIEF formation difficulties, which are adding to existing workloads for potential registrants.
*The text of the REACH Regulation (EC) No 1907/2006 is the only authentic legal reference. The information in this column does not constitute legal advice.
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