Naturvetenskap och tillämpad vetenskap

This document specifies general criteria to be applied in the determination of bacterial endotoxins on or in health care products, components or raw materials using bacterial endotoxins test (BET) methods, using amebocyte lysate reagents. This document is not applicable to the evaluation of pyrogens other than bacterial endotoxins. Other endotoxin detection methodologies are not included. This document does not address setting specific endotoxin limit specifications.

This document specifies a method for the qualitative detection of DNA of the general wheat and rye in cooked sausages using real-time PCR based on the glutenin gene, in the context of allergen analyses. This document does not apply to differentiating between wheat (Triticum L.) and rye (Secale cereale). The method was previously validated in an interlaboratory study (ring trial).

The limit of detection of the wheat and rye real-time PCR has been determined experimentally to be around 80 mg wheat or rye per kg for the matrix ‘cooked sausage’. For autoclaved material the detection limit can increase significantly.

This document specifies a method for the qualitative detection of peanut (Arachis hypogaea) DNA in food using real-time PCR and targeting a multicopy mitochondrial sequence, in the context of allergen analyses. The method was previously validated in an interlaboratory study (ring trial) and applied to DNA extracted from samples that consist of defined proportions of peanut in rice biscuits, wheat biscuits, cooked sausage and milk powder.

The limit of detection of the peanut real-time PCR has been determined experimentally to be at least 0,5 mg peanut/kg.

This document specifies a method for the qualitative detection of the species-specific DNA of peanut (Arachis hypogaea), hazelnut (Corylus spp.), walnut (Juglans regia) and cashew (Anacardium occidentale) in food of animal and plant origin, using real-time PCR, in the context of allergen analyses.

The method was previously validated in an interlaboratory study (ring trial) and applied to DNA extracted from samples that consist of defined proportions of peanut, hazelnut, walnut and cashew in rice biscuits, cooked sausage, sauce powder, vegan cookie and veggie burger (powder). The limit of detection of each real-time PCR has been determined experimentally to be about 5 mg/kg (10 mg/kg for roasted peanuts).

This document specifies a method for the qualitative detection of fish DNA in food, of both animal and plant origin, using real-time PCR based on the Hoxc13 gene, in the context of allergen analyses. This document does not apply to representatives of the genus of cartilaginous fish (Chondrichthyes), such as sharks or rays. It is also not applicable for differentiating between fish species.

The method was previously validated in an interlaboratory study (ring trial). The limit of detection of the fish real-time PCR has been determined experimentally to be at least 50 mg fish fresh weight/kg.

This document describes a risk management approach, called Risk Analysis and Biocontamination Control (RABC), designed to enable laundries to continuously ensure the microbiological quality of laundry processed textiles. The RABC approach applies to laundry market sectors where it is necessary to control biocontamination, e.g. pharmaceuticals, medical devices, food, healthcare and cosmetics. The RABC approach excludes those aspects relating to worker safety and sterility of the final product.