Biocide under transitional Legislation - Biocides

Definitions and FAQs

In order to try to make some clarity on the definitions and the most common questions, we take inspiration

from the accredited sources indicated below, specifying that the following is at the best of our knowledge,

(updated in May 2020), but does not replace official sources, which are constantly evolving given the particu-

larly complex context of Covid-19.

Biocide under transitional Legislation (PMC) and Biocides

Biocide under transitional Legislation comprise a series of disinfectant products and substances placed on the

market such as germicidal or bactericidal, insecticides, rodenticides for domestic and civil use and insect re-

pellents. The national legislation governing the placement on the market of these products, the P.D.R. 392 of 6

October 1998, will be completely replaced by the European legislation on Biocidal Products, Regulation (EU)

528/2012, BPR (Biocidal Products Regulation), thus entailing the integration of the Biocide under transitional

Legislation in the Biocide category. At European level, the list of active ingredients present in the products on

the market is being revised and, once approved, can be used subsequently for the preparation of Biocides.

The final list of active ingredients accepted in Europe will be completed by 31/12/2024.

PMC (Biocide under transitional Legislation) what are they?

As provided for in Article 1 of the P.D.R. 392 of 6 October 1998 Italian Law, the following types of products are:

> Disinfectants and substances placed on the market as germicidal or bactericidal

> Insecticides for domestic and civil use

> Insect repellents

> Biocides for mice and rats for domestic and civil use

PMC (Biocide under transitional Legislation) marketing authorization number

During the transitional period between the PMC and the legislation on Biocidal products, in particular pending

the inclusion of all active ingredients in the Union list, Member States shall continue to apply their national

legislation. In Italy, the Biocide under transitional Legislation can be placed on the market only after prior re-

gistration with the Ministry of Health according to the P.D.R. no. 392 of October 6, 1998, and the provision of

February 5, 1999. Only the Biocide under transitional Legislation containing active ingredients under review

for the specific PT field of application, of which we mention the most common ones: PT1 human disinfection,

PT2disinfection of surfaces, PT3 veterinary disinfection, PT4 disinfection of surfaces in contact with food, PT5

drinking water treatment, etc. As a result of European legislation on Biocidal Products, PMC containing active

ingredients with biocidal products (which are listed in the Union) must be authorized as Biocidal Products in

order to be able to be kept on the market. For the purposes of marketing authorization as PMC it is necessary

to obtain from the Ministry of Health the “Registration of the Ministry of Health no...” to be written on the label.

Biocides what are they?

According to Regulation (EU) 528/2012 Biocides products are:

>Any substance or mixture in the form in which it is supplied to the user, consisting of or containing or capable

of generating one or more active ingredients that destroy, eliminate and render harmless, prevent action

or have any other control effect on any harmful organism, by any means other than mere physical or me-

chanical action;

>Any substance or mixture, generated by substances or mixtures which do not fall as such in the above defi-

nition, used with the intent of destroying, eliminating, rendering harmless, preventing action

or have any other control effect on any harmful organism, by any means other than mere physical or me-

chanical action;

>A treated item that has a primary biocidal function shall be considered a biocidal product.

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