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Public access to information on chemicals is a central element of both CHINA NCSN (CR) and EU REACH (ER) and people should be allowed to make informed decisions on the use of chemicals to which they may be exposed. All the information to be published should obey the rules of maximum possible transparency. These rules aim at ensuring the public’s availability to regulatory, scientific or technical information concerning the safety of the substances.
It is inevitable that some information is not disseminated for the reason that the release of the information would be harmful for registrants’ commercial interest or that of any other party concerned or the competitors could make use of the information and there must be a causal link between publication of the information and the potential harm. Therefore, companies choose to claim confidentiality.
From the view of public interest, publication of information about safety of chemical substances represents transparency, while considering from the legitimate commercial interest of registrants, information protection is very important. It is necessary to achieve a fair balance between providing the general public with information on chemicals that have been registered while ensuring that registrants may exercise any legitimate rights to safeguard their business secrets or protecting other commercially sensitive information.
Current Situation of Information Publicity and Confidentiality under China NCSN and EU REACH
There are articles on information dissemination and confidentiality of chemicals in both CHINA NCSN and EU REACH and the requirements is similar in some aspects. For example, in accordance with Article 18 of Measures on the Environmental Management of New Chemical Substances (MEP Order 7), the information of the substance hazards to human health and environmental safety should not be claimed confidential. Similarly, in line with Article 118(2) of REACH, in cases where urgent action is essential to protect human health, safety or the environment, such as emergency situations, ECHA may disclose information which would normally be considered confidential.
However, a lot of differences between CHINA NCSN and EU REACH on the information dissemination and confidentiality exist.
Information Dissemination and Confidentiality under China NCSN
According to the guidance of New Chemical Substance Notification, once the registration approved, a registration certification will be issued by the MEP. Otherwise, the notifier will be informed of the decision and the reasons for rejection. The name of the registered new chemical substance will be announced on the MEP government website every 6 months (if substance name is confidential, generic name shall be published). Other information to be published includes notifier, notification type and the management category of new chemical substance, etc.
In accordance with Article 18 of Measures on the Environmental Management of New Chemical Substances (MEP Order 7), notifiers should claim confidential business information or technical information mentioned in all relevant notification documents. In addition, the confidential information claim has to be filed with CRC in writing beforehand.
Information Dissemination and Confidentiality under EU REACH
Information publicity and confidentiality is managed in a more systematic way under EU REACH. For example, EU REACH provides special dissemination plug-in to check what information will be published before submission. Besides, FAQ document specifies operation details on disclosing information and updated data submission manuals relating to confidential requirement are released on European Chemicals Agency (ECHA)’s website.
In accordance with Articles 119(1) and (2) of EU REACH, ECHA is required to publish information it holds on registered substances free of charge on the internet. However, in certain cases information can be withheld, if the registrant submitting the information also submits a justification as to why publishing the information would be potentially harmful to the commercial interests of the registrant or any other parties concerned. Each piece of information falling under REACH Article 119(2) which is claimed confidential will be assessed based on the justification provided, and only those pieces of information whose confidentiality justification evaluated as valid by ECHA will not be disseminated.
It should be noted that more information from registration dossiers will be published on the ECHA website since November 2012, following a re-interpretation of the scope of Article 119(2) (d) of the REACH Regulation. According to this re-interpretation, the information made available will include the registrant name, the registration number as well as other items normally contained in a Safety Data Sheet (SDS). Companies wishing to request confidentiality on these items need to update their dossiers and justify their requests for confidential treatment. If no confidentiality request is presented in the dossier, the information will be made publicly available on ECHA’s website. Dossiers that need to be updated with confidentiality requests should be resubmitted by 31 October 2012.
To help the registrants to review their company’s dossier, the upgraded IUCLID 5.4 Dissemination plug-in is available for free from the IUCLID website. The plug-in allows the registrants to simulate which information from their company’s dossier will be made available on the ECHA website before submission. Additionally, the Data Submission Manual 15 explains how to determine what will be published on the ECHA website from the registration dossier, with and without confidentiality claims. The technical annexes show which information will be disseminated with screenshots of the entire registration dossier.
It is important to note that in case of confidentiality claims for information covered by REACH Article 119(2), a fee will be incurred and the claim must be accompanied by a full justification. In such cases the confidentiality claim will be approved only when the appropriate fee is paid and the justification evaluated as valid by ECHA.
Conclusion
Both CHINA NCSN and EU REACH have relevant requirements on information dissemination and confidentiality. Compared with EU REACH, articles relating to information publicity and confidentiality in CHINA NCSN seem over simplified. The disseminated information in CHINA NCSN is very limited, only the name of the new chemical substance, notifier information, notification type and the management category of new chemical substance are included. While under EU REACH, the information contains EINECS name & IUPAC name of the substance, trade names of chemicals, registration number, total tonnage band, Legal entity details (including manufacturer, OR and EU importers), classification & labeling and PBT assessment, uses and uses advised against, exposure and risk assessment, physical and chemical data, environmental fate and pathways data, toxicological and eco-toxicological data, guidance on safe use and whether a chemical safety assessment was carried, etc.
