Page 11 - FACOT CHEMICALS - LINEA COMFORT

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.

Can a PMC (Biocide under transitional Legislation) registered in Italy
be freely sold to other European countries?
Each country has its own legislation and therefore not all the products that are registered in Italy must follow
a similar procedure in other countries.

Does a PMC (Biocide under transitional Legislation)
automatically become a biocidal product?
No, when the active ingredient of the PMC is approved for use in biocidal products it is necessary to submit a
new application for authorization as a biocidal product, otherwise it must be withdrawn from the market.

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