The European Chemicals Regulation REACH requires the European Chemicals Agency ECHA to screen five percent of all registration dossiers for completeness. Ms Krautzberger commented: "The ECHA needs more resources to screen registrations. The situation will only improve if a sufficient number of dossiers are screened and incomplete registrations are not accepted."
Of the 1,814 dossiers on chemicals of commercial importance which were evaluated for the first REACH registration period (2010), 58% do not comply with at least one of the seven requirements checked; 27% are non-compliant with two or more. These requirements include degradability in the environment or effects on reproduction. Risks to man and the environment can be overseen without sufficient information.
Registration information is important for industrial and commercial users to be able to assess risk potential and to take measures to protect people and the environment as necessary. Such information is also essential for the producers of consumer goods to assume responsibility for their products. The authorities must have reliable data in the dossiers in order to identify any chemicals which might require regulation.
The BfR classified 42% of the examined dossiers as "complex". Registrants sometimes presented a justification for data waiving, e.g. by presenting data on a similar chemical in a grouping/read-across approach. This is done to avoid animal testing. A follow-up study will now assess if this approach is scientifically sound.
European Chemicals Regulation REACH:
Since 2010 producers and importers must register chemicals with the European Chemicals Agency ECHA. Registration must include information which enables assessment of their risk to man and the environment. This is laid down by the European Chemicals Regulation REACH. The ECHA is required to verify 5% of all registration dossiers for completeness. The competent authorities in the EU countries rely on these dossiers to assess the risks of chemicals to human health and the environment. When warranted they call for further studies or statutory regulation of a chemical and its use. Incomplete information in the dossier can therefore result in unreliable evaluations of chemicals.
More than 4,300 chemicals had to be registered within a short time in the first registration period. Some substances were intermediates and substances classified as substances with carcinogenic, mutagenic or reprotoxic properties (CMRs) whose production volume is less than 1,000 tons per year. The some 2,300 chemicals in this latter category were exempted from screening. The remaining roughly 2,000 registrations of chemicals with production or import volumes of more than 1,000 tons per year were screened by the BfR in the study. The registration obligation was extended in the second registration period (2013) to all chemicals with an annual production or import volume of 100 or more tons. The last transitional period of the registration obligation ends in 2018. Any remaining chemicals must be registered with adequate documentation by that date.