The European Chemicals Agency (ECHA) has posted the German Federal Institute for Occupational Safety and Health’s (BAuA)substance evaluation conclusion document对于多壁碳纳米管（MWCNT），在筒状而纠结合成石墨。结论提供了如何在物质的信息可以用于监管风险管理的目的摘要。
Concern(s) Subject to Evaluation
MWCNTs were originally selected for substance evaluation to clarify concerns about:
- Wide spread use;
- Consumer use;
- Discrepancy in self-classification between different registrants of the joint submission(s);
- 在物理化学性质的差异，影响毒性，e., number of different registered nanoforms and the choice of representative test material(s);
- Suspected specific target organ toxicity – repeat exposure (STOT RE) (differing no observed adverse effect levels (NOAEL)/no observed adverse effect concentrations (NOAEC) in several animal studies using different forms of the same test material);
- Suspected carcinogen;
- Effects on environmental organisms;
- Suspected environmental exposure;
- Cumulative exposure; and
- Suspected persistency.
Overview of Other Processes/EU Legislation
Conclusion of Substance Evaluation
The evaluation of the available information on the substance has led Germany to the following conclusions, as summarized in the table below.
According to the report, in the framework of the substance evaluation, it was not possible to resolve the concerns described above. The report states that based on ambiguities regarding the registered nanoforms, as well as based on the late updates of some of the dossiers at the very final stage of the substance evaluation, “it does not seem expedient to conclude on the substance evaluation with a decision on data requests at the present time.”
According to the report, BAuA currently considers it necessary for ECHA to examine first if all information according to REACH Annex VI are available within the framework of a compliance check. If information is missing, these data should be requested by respective decisions. Once all data are available, it has to be decided if further information is needed to clarify a remaining concern and if this should be requested in the framework of a compliance check or a substance evaluation.
Apart from potential requests as consequences of a compliance check, the report urges registrants to update their dossiers and/or develop testing proposals to adhere to REACH requirements.
|Need for follow-up regulatory action at EU level|
|Harmonized Classification and Labeling|
|Identification as Substance of Very High Concern (SVHC) (authorization)|
|Other EU-wide measures|
|Currently no need for regulatory risk management follow-up action at EU level; outcome of compliance check needs to be awaited first|
Currently No Follow-Up Foreseen at EU Level
Not possible for the time being. Compliance check is needed first.
Tentative Plan for Follow-Up Actions (If Necessary)
|Follow-Up Action||Date for Intention||演员|
|Potential inclusion to the Community Rolling Action Plan (CoRAP) for resuming substance evaluation||TBD||DE-CA|
According to the report, the need for a re-opening of the substance evaluation process will be determined based on the outcome of the new information generated via the Compliance Check procedure.