The EU recently released a 140-page “REACH†data sharing guideline document, which focuses on data sharing mechanisms for “existing†chemical substances. This document will apply to most chemicals sold in the EU market. The data sharing regulations are one of the most important provisions of REACH and have attracted the attention of manufacturers and importers.
It is understood that the EU's REACH data sharing guidance document specifies the relevant provisions. Pre-registration means that if the annual production or import of existing chemical substances is equal to or exceeds 1 ton, it must be registered in advance with the European Chemicals Agency before the registration period can be extended. Chemical substances that may be released from imported products must also be registered in advance. However, simple information such as the identity of the registrant and the name of the substance is not required, and it is not necessary to provide chemical substance composition information. The pre-registration period is from June 1st to December 1st, 2008. The relevant units can be pre-registered through the European Chemical Agency's "REACHIT" system. Persons or institutions that fail to apply for pre-registration before the deadline will be suspended for their business activities and may be fined.
The registration requirements stipulate that non-EU producers (such as Chinese manufacturers) cannot register themselves, but their EU importers or their "only representatives" can register for imported products. Manufacturers who have already registered in advance may extend the registration period to November 30, 2010, May 31, 2013 or May 31, 2018 (based on annual production or import quantities and characteristics of chemical substances).
Joint registration requires REACH registrants to jointly submit information on the toxicity of chemical substances, classes, labels, and a number of new test recommendations. Other parts of the registration documents, such as guidelines for the safe use of chemical substances and chemical safety reports, may be submitted jointly or individually. In some cases, the registrant may choose not to submit the joint submission. For example, if the joint submission is too expensive, the submission of information may result in leakage of sensitive commercial information, and the registrant holds an objection to the selection of the information.
The REACH regulation also establishes the "Materials Information Exchange Forum" to allow producers, importers and sole representatives to share information on registration matters, and to agree on the classification and labeling methods of related substances. The forum is not a legal entity but a platform for easy data sharing and generation. Each pre-registered substance will have a separate forum.
REACH requires companies that share information on the forum to decide the costs in a fair and open manner. EU competition regulations apply to data sharing. Therefore, manufacturers should limit their data-sharing activities to the areas stipulated by REACH and avoid exchanging market-sensitive data in order to avoid violating EU competition regulations.
It is understood that the EU's REACH data sharing guidance document specifies the relevant provisions. Pre-registration means that if the annual production or import of existing chemical substances is equal to or exceeds 1 ton, it must be registered in advance with the European Chemicals Agency before the registration period can be extended. Chemical substances that may be released from imported products must also be registered in advance. However, simple information such as the identity of the registrant and the name of the substance is not required, and it is not necessary to provide chemical substance composition information. The pre-registration period is from June 1st to December 1st, 2008. The relevant units can be pre-registered through the European Chemical Agency's "REACHIT" system. Persons or institutions that fail to apply for pre-registration before the deadline will be suspended for their business activities and may be fined.
The registration requirements stipulate that non-EU producers (such as Chinese manufacturers) cannot register themselves, but their EU importers or their "only representatives" can register for imported products. Manufacturers who have already registered in advance may extend the registration period to November 30, 2010, May 31, 2013 or May 31, 2018 (based on annual production or import quantities and characteristics of chemical substances).
Joint registration requires REACH registrants to jointly submit information on the toxicity of chemical substances, classes, labels, and a number of new test recommendations. Other parts of the registration documents, such as guidelines for the safe use of chemical substances and chemical safety reports, may be submitted jointly or individually. In some cases, the registrant may choose not to submit the joint submission. For example, if the joint submission is too expensive, the submission of information may result in leakage of sensitive commercial information, and the registrant holds an objection to the selection of the information.
The REACH regulation also establishes the "Materials Information Exchange Forum" to allow producers, importers and sole representatives to share information on registration matters, and to agree on the classification and labeling methods of related substances. The forum is not a legal entity but a platform for easy data sharing and generation. Each pre-registered substance will have a separate forum.
REACH requires companies that share information on the forum to decide the costs in a fair and open manner. EU competition regulations apply to data sharing. Therefore, manufacturers should limit their data-sharing activities to the areas stipulated by REACH and avoid exchanging market-sensitive data in order to avoid violating EU competition regulations.