According to article 7, paragraph 1 of the REACh regulation substances intentionally released from articles need to be registered in case the amount of the substance exceeds 1 tonne per year and the release occurs under normal and foreseeable conditions. In article 7, paragraph 2 it is laid down that candidate substances present in more than 0.1% and beyond 1 tonne per year need to be notified to ECHA.
According to article 33 manufacturers and importers of articles have the obligation to inform their customers about the safe use of an article if it contains more than 0.1% of a candidate substance. Consumers need to be provided with information upon request.
While the determination of the presence and concentration of candidate substances is rather easy it is a difficult task in complex articles. If the opinion of the Advocate General of the European Court of Justice concerning the determination of the threshold value of 0.1% in complex articles will be implemented in the decision of the court, importers of complex articles are responsible for the correct notification of candidate substance uses in each component of the complex article. Information obligations according to article 33 have to be covered as well.
Our specialists in regulatory compliance at Dr. Knoell Consult will be happy to support you in analyzing your portfolio and determination of the obligations derived from the results, like for example the presence of candidate substances.
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