SUNIVO REACH Newsletter(1)

ISSUE 1-01st February 2009

SUNIVO is building up bridges and collaborative schemes with other regulation service providers, in the fields of REACH testing, supply chain management. We have created experts team in order to offer our business friendly services to comply with REACH regulation.

The six-month pre-registration period was closed on December 1st. A key element of REACH is a phased registrations program for existing chemical substances. Pre-registration enables companies to enter substances into this process.

Companies, who have pre-registered, benefit from the transitional provisions in REACH and are able to continue supplying their ‘phase-in’ substances until the appropriate registration deadline. While Companies, who supply ‘phase-in substances’ for the first time in the EU are able to make a later pre-registration and therefore, enter the registration program.

In contrast, current suppliers who failed to pre-register substances by December 1st deadline cannot legally produce or import until they have successfully registered them with ECHA.

All pre-registered substances were submitted by more than one company. Therefore registrants of the same substance will need to cooperate in order to submit a consolidated registration dossier containing the technical information of this substance. Moreover, companies must cooperate to share test data on the properties of this substance. To achieve this, they must move from the pre-SIEF to the SIEF (substance information exchange forum), agreeing on a common definition of the substance. There will be many challenges in relation to For a successful cooperation, many challenges need to be overcame, especially challenges related to the huge members and substances amount for SIEF, knowing that these steps need to be completed by the first deadline…

Article 29 of the REACH Regulation provides that all Potential Registrants and Data Holders for the "same" phase-in substance shall be participants in a SIEF. However, the REACH Regulation does not define "sameness" and it does not foresee any formal step to confirm the establishment of sameness and the formation of a SIEF.

The assessment of the exact nature of an EINECS entry and the different substances it may cover can only be carried out by the manufacturers or importers who should be aware of the composition of the substance. It is, therefore, up to them to take the responsibility of defining precisely the substance for which a SIEF will be formed.

In order to reach an agreement on the sameness of a substance, Pre-Registrants must enter into pre-SIEF discussions. As a consequence of this, a SIEF is formed when the Potential Registrants of a substance in the pre-registration list, actually agree that they effectively manufacture, intend to manufacture or import a substance that is sufficiently similar to allow a valid joint submission of data.

Data Holders will not be involved in pre-SIEF discussions. They will be considered as members of a relevant SIEF once it is formed as a consequence of the pre-SIEF discussions between Pre-Registrants of the same identifier (e.g EINECS entry). Since data holders do not know the contact details of the potential registrants who have pre-registered under the same identifier, it is the role of the potential registrants to evaluate for which substance(s) within this identifier the data are relevant and to which SIEF(s) the data holder participates.

ECHA will not participate in the discussions between Potential Registrants and there will be no role of ECHA in confirming or rejecting the creation of a particular SIEF.

However, REACH IT will allow posting information on the creation of SIEFs in two dedicated free fields on the substance web-page. In the first free field, writing rights will only be given to the SIEF Formation Facilitator. In the second free field, all Pre-Registrants of the substance will have writing rights. All messages in these two free fields will be the exclusive responsibility of the authors and ECHA will neither verify nor approve or disapprove their contents.

It is recommended that the SIEF Formation Facilitator uses the first free text field to post messages on the creation of a SIEF and to give contact details and information on further communication tools (e.g. dedicated industry websites). The second free field will allow other Pre-Registrants to give comments (e.g. in case of disagreement with the SIEF Formation Facilitator). Both free fields will allow only a limited number of characters and should therefore only be used for key messages and referring to further contact details and/or communication tools.

SUNIVO Recommendation: potential registrants should work towards forming SIEFs as soon as possible to ensure sufficient time remains available to organize data sharing and prepare the registration dossiers, in particular for high volume substances considering the registration deadline of 30 November 2010. If you have any issue facing with REACH or trade in Europe, please feel free to contact us.