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Key Facts

Germany

Map of Germany

Reception Date

02.12.19

Category

CHEMICALS

Hazardous substances and preparations

Ministries & Departments

Ministerium für Soziales, Gesundheit, Jugend, Familie und Senioren, Referat VIII 403,

Responsible Departments

Bundesministerium für Wirtschaft und Energie, Referat E B 2, 11019 Berlin,

Products & Services concerned

§ 2(8) of the State Ordinance concerns biocidal products used as disinfectants in certain medical facilities.

Related EU Law

-

Explanation

In facilities for the medical examination and treatment of patients, disinfection measures must be carried out. The use of potent disinfectants is imperative for the various applications in order to adequately protect patients against infections. The use of effective disinfectants can prevent the transmission of infectious agents via hands, medical devices and other materials as well as by a contaminated environment. In particular, the presence of resistant pathogens requires the use of reliably effective and appropriately tested disinfectants. Because antibiotic resistance makes it increasingly difficult to treat severe infections, it is even more important to prevent infections with these resistant pathogens from the outset. Because the mechanism of action of disinfection procedures differs from that of anti-infective agents and antibiotic resistance is not automatically associated with resistance to disinfection procedures, the use of disinfection procedures is an important tool for preventing infections, especially with resistant and multi-resistant pathogens.

Summary

Disinfectants used to protect people against infection with pathogens of communicable diseases in hospitals, preventive care or rehabilitation facilities with medical care comparable to that of hospitals, outpatient surgery facilities, dialysis facilities or day hospitals must be suitable for preventing infection at these facilities and proven to be effective in doing so. The (bacterial, viral, yeasticidal, tuberculocidal, mycobactericidal, fungicidal or sporicidal) efficacy required for each area of use must be documented by at least two independent test reports and associated expert reports. The test reports must meet requirements for the test methodology and must have been prepared by manufacturer-independent, accredited testing institutes. The test reports and export reports must have been scientifically evaluated by an independent commission of experts.

Notification Timeline

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Law is drafted in Germany Germany notifies the draft law 02.12.19 Draft law returns to Germany Commenting Periode Ends 03.03.20 1 Member States & EC Responses 0 Detailed Opinions 1 Comments 4 External Stakeholders Responses

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