Regulations

An EU-wide enforcement project found one in three Antimicrobials of the checked products did not comply with the legal requirements. The national enforcement authorities in 29 countries checked over 3 500 Antimicrobial products. Overall, 37 % of the checked products were non-compliant with at least one of the checked legal requirements.
18 % of checked products were non-compliant with fundamental requirements that affect their safe use. Most of them either lacked a product authorisation or included non-allowed active substances.
Inspectors found about 60 active substances that are not allowed in these products. All products that lacked authorisation or contained non-allowed active substances were withdrawn from the market. In some cases, criminal complaints or fines were issued.
The remaining 19 % non-compliant products were found to have minor deficiencies that did not affect safe use such as missing contact information of the supplier. In these cases the national enforcement authorities gave advice or administrative orders.
In most developed countries, all the chemical components of an Antimicrobial must be listed on the relevant national “inventory” of chemical substances before it can be supplied. In addition, the usage of Antimicrobials in precise applications such as skin-contact applications, will always be subject to additional legislation which often requires a specific product registration.
In the USA for example, Antimicrobials are listed on the national inventory of chemical substances which is called TSCA. Alongside the listing on TSCA, there are regulations governing the use of antimicrobials on both the federal (EPA or FDA for skin contact applications) and state level.
In Europe, the regulations governing the use of Antimicrobials are via BPR. There are some exceptions such as specialist applications e.g. Cosmetics.
For the rest of world, countries have their own regulations governing the use of Antimicrobials or rely on the Antimicrobials to have BPR / EPA approval.