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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Classification & Labelling & PBT assessment

GHS

General Information

Name:
Biomass residue ex B2
Not classified
Implementation:
EU
Remarks:
B. subtilis does not pose any risk to human health or to the environment. It meets the criteria defined by § 3 of the german Biostoffverordnung. The german Liste risikobewerteter Spender- und Empfängerorganismen für gentechnische Arbeiten as a statement of the german Zentrale Kommission für Biologische Sicherheit (ZKBS) confirms this explicitly ( BVL 78/2009/4, BAnz. Nr. 59a, 21.04.2009). By contrast, B. subtilis is not listed in annex 3 of the european guideline 2000/54/EWG because the annex contains only microorganisms that may have a potential to cause diseases within human beings.
An expertise of the Fraunhofer Gesellschaft has analyzed the complete data of the biomass residue from the fermentation of riboflavine (Vitamine B2) and concluded that there is no risk to the environment. The ZKBS, particularly referring to fermentation residue ex B2, even states that no further treatment is required prior to disposal, independent from the volumes. Consequently the german authorities have permitted the widespread use of the biomass as a fertilizer, based on German Waste Legislation (Bioabfallverordnung). Since 2008 several thousand tons of biomass residue ex B2 have been applied safely in this way every year. Biomass residue ex B2 is listed as approved fertilizer in the Düngemittelverordnung annex 2 table 7 section 7.1.8.
Furthermore, european regulation No. 1137/2007 approves B. subtilis (DSM 17299) for use even as a feed additive.
See section 13 "assessment reports"

Related composition

Related composition:
Biomass residue ex B2

Classificationopen allclose all

Explosives
Reason for no classification:
data conclusive but not sufficient for classification
Flammable gases and chemically unstable gases
Reason for no classification:
data conclusive but not sufficient for classification
Aerosols
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
hazard class not assessed
Oxidising gases
Reason for no classification:
data conclusive but not sufficient for classification
Gases under pressure
Reason for no classification:
data conclusive but not sufficient for classification
Flammable liquids
Reason for no classification:
data conclusive but not sufficient for classification
Flammable solids
Reason for no classification:
data conclusive but not sufficient for classification
Self-reactive substances and mixtures
Reason for no classification:
data conclusive but not sufficient for classification
Pyrophoric liquids
Reason for no classification:
data conclusive but not sufficient for classification
Pyrophoric solids
Reason for no classification:
data conclusive but not sufficient for classification
Self-heating substances and mixtures
Reason for no classification:
data conclusive but not sufficient for classification
Substances and mixtures which in contact with water emit flammable gases
Reason for no classification:
data conclusive but not sufficient for classification
Oxidising liquids
Reason for no classification:
data conclusive but not sufficient for classification
Oxidising solids
Reason for no classification:
data conclusive but not sufficient for classification
Organic peroxides
Reason for no classification:
data conclusive but not sufficient for classification
Corrosive to metals
Reason for no classification:
data lacking
Desensitized explosives
Reason for no classification:
data lacking
Acute toxicity - oral
Reason for no classification:
data conclusive but not sufficient for classification
Acute toxicity - dermal
Reason for no classification:
data conclusive but not sufficient for classification
Acute toxicity - inhalation
Reason for no classification:
data lacking
Skin corrosion / irritation
Reason for no classification:
data conclusive but not sufficient for classification
Serious eye damage / eye irritation
Reason for no classification:
data conclusive but not sufficient for classification
Respiratory sensitisation
Reason for no classification:
data lacking
Skin sensitisation
Reason for no classification:
data conclusive but not sufficient for classification
Aspiration hazard
Reason for no classification:
data lacking
Reproductive toxicity
Reason for no classification:
data conclusive but not sufficient for classification
Effects on or via lactation
Reason for no classification:
data lacking
Germ cell mutagenicity
Reason for no classification:
data conclusive but not sufficient for classification
Carcinogenicity
Reason for no classification:
data lacking
1. Specific target organ toxicity - single (STOT-SE)
Reason for no classification:
data conclusive but not sufficient for classification
1. Specific target organ toxicity - repeated (STOT-RE)
Reason for no classification:
data conclusive but not sufficient for classification
Hazardous to the aquatic environment (acute / short-term)
Reason for no classification:
data conclusive but not sufficient for classification
Hazardous to the aquatic environment (long-term)
Reason for no classification:
data conclusive but not sufficient for classification
Hazardous to the ozone layer
Reason for no classification:
data lacking

Labelling

Signal word:
No signal word

Notes