EU REACH: First Coordinated REACH Enforcement Project Started
No. 15/ 2009 REACH-EN-FORCE-1 REACH-EN-FORCE-1, a joint REACH enforcement project, has started across Europe. National inspectors are checking pre-registrations, registrations and – where applicable – the provisions for Safety Data Sheets. The Forum for Exchange of Information on Enforcement, meeting for the fourth time this week in Helsinki, reviewed the start of the project and agreed on the further steps.
The enforcement project of the Forum enforces the core principle of REACH: no data, no market. Inspectors in the participating countries will focus on the phase-in substances (existing substances) and check through inspections whether companies have submitted a pre-registration or a registration and, where necessary, whether a Safety Data Sheet has been supplied.
The project will thus give a first impression of the level of compliance by manufacturers and importers (including only representatives) with REACH in the European Union and European Economic Area. At the same time, the capacity of the enforcement authorities to enforce REACH will be enhanced.
A designated national coordinator will oversee the implementation of the project in each participating country and provide training for local inspectors. For that purpose, the national coordinators were trained by the Forum Working Group at ECHA’s premises earlier in April. The results of the project will be collected by the end of 2009 and the Forum Working Group will analyze the results and produce a report in early 2010. The Forum is also preparing a second coordinated project to be launched in 2010.
Pre-registrants Categories The Agency has announced more than 2.7 million pre-registrations and some 150.000 pre-SIEFs (Substance Information Exchange Forum). With these huge numbers in mind and in order to work in a very short time frame, Cefic is proposing a methodology to facilitate the efficient managing of the activities required by the SIEF. One can classify all pre-registrants in 4 categories:
In many cases it is clear that companies have pre-registered only to secure their business, without intention for later full registration. For these pre-registrants, there is - besides the data sharing obligation - no need to be actively involved in all SIEF communication: these pre-registrants could be on a dormant status.
Another case is that of pre-SIEF members who may plan to register, but have limited resources or interest to actively participate in the discussions. These are only interested in the final part of the joint-registration. They can be considered passive.
A third group of pre-SIEF members are those who want to be involved in the dossier creation process and to register. However they are not able to make resources available to participate in all the SIEF activities.
And finally there will be a group of pre-SIEF members for whom the substance is of strategic value, who may be in strong market positions, and who can make resources available to actively participate in or manage the required SIEF activities. They will be the companies leading the work and discussions in the SIEF. REACH Fact Sheet ECHA has published a REACH Fact Sheet providing registrants top tips on how to get started in SIEFs (Substance Information Exchange Fora). SIEFs have a critical role within REACH and ECHA wants to do what it can to try to ensure that they succeed in sharing and assessing data as well as preparing the common parts of the registration. At the same time, the Agency would like to remind companies that SIEFS are independent – they are not “owned” by ECHA.
SIEFs SIEFs are formed by companies that intend to register the same substance. One of their tasks is to facilitate data sharing between the companies, and hence avoid duplication of studies and unnecessary animal testing. Industry has made ECHA aware that there have been difficulties in getting some SIEFs started and potential problems with communication between members. In response, ECHA recently chaired a meeting of industry associations and staff from the Commission. The meeting sought to discuss the problems that had arisen, clarify the requirements of SIEF members and help to ensure sharing of best practice. The linked fact sheet is a result of the meeting and presents the key advice that arose from it. If you have pre-registered a substance that you intend to register, it is really important that you get involved in the most appropriate SIEF for your substance as soon as possible. The deadlines are tight. So if you have not started, start now. Please note that the deadlines for submission of registrations are laid down in the REACH regulation and ECHA does not have the power to change them. In practice this means that if you don’t have a valid registration by the appropriate deadline, your manufacture or import would need to cease.
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