• What is a “Presidio Medico Chiurgico”?
• Why are we in a transition period?
• What are Biocides?
• What is meant by “revision programme of active substances”?
• What does Annex I of the Directive 98/8/EC contain?
• What does Annex IA of the Directive 98/8/EC contain?
• What happens when an active substance is excluded from Annex II and is not included in Annexes I or IA of the Directive 98/8/EC?
• How do I know if a specific product belongs to the classification of biocides?
• How do I know if a specific active substance has been included in Annexes I or IA or if it has been excluded from Annex II of the Directive 98/8/EC?
• Is there any difference between registration and authorisation of a biocidal product?
• How can your consultancy company assist our company in authorising a biocidal product?

What is a “Presidio Medico Chiurgico”?

“Presidi Medico Chirurgici” belongs to a class of product, such as disinfectants, insecticides, insect-repellents, rodenticides and rat-killers, which require to be nationally authorised by the Ministry of Health in order to be placed on the market. The proper definition of “Presidi Medico Chirurgici” is given in the first article of the D.P.R. n. 392 of the 6th of October 1998, in which the points d-e must be excluded.

Why are we in a transition period?

Because the Italian legislation regulating the PMC marketing authorisation will be entirely substituted by the European regulations on Biocides. At the moment, in order to obtain the marketing authorisation of a product belonging to the biocidal classification, it is necessary to consider both legislations.

What are Biocides?

According to the definition given in the Directive 98/8/EC, implemented into the Decreto Legislativo n. 174 of the 25th of February 2000, the term Biocides refer to “active substances and preparations containing one or more active substances, presented in the form in which they are to be supplied to users, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by chemical or biological means”.

What is meant by “revision programme of active substances”?

This is the ten-year revision programme, established by the Directive 98/8/EC, regarding all   the active substances present on the market before the 14th of May 2000. The objective of this program is to identify and group those substances whose use in the preparation of biocides could be appropriate.

What does Annex I of the Directive 98/8/EC contain?

Annex I of the Directive 98/8/EC contains all the active substances considered as suitable for the preparation of biocidal products.

What does Annex IA of the Directive 98/8/EC contain?

Annex IA of the Directive 98/8/EC contains the non dangerous active substances which are usable for the preparation of “low risk biocidal products”

What happens when an active substance is excluded from Annex II and is not included in Annexes I or IA of the Directive 98/8/EC?

When an active substance is excluded from Annex II and is not included in Annexes I or IA of the Directive 98/8/EC it is not possible to authorise a product as a biocidal product containing that particular active substance for that specific intended use.

How do I know if a specific product belongs to the classification of biocides?

It is necessary to evaluate if the intended use of the products belongs to the classification of PTs (“Product Type”) and if the active substances are included in Annexes I or IA for that particular PT:

How do I know if a specific active substance has been included in Annexes I or IA or if it has been excluded from Annex II of the Directive 98/8/EC?

After the exclusion or inclusion of an active substance, a European directive and the respective national decree reporting this information are always published

Is there any difference between registration and authorisation of a biocidal product?

Yes. A biocidal product registration can be required only when the active substances are included in Annex IA of the Directive 98/8/EC. A biocidal product authorisation has as a fundamental requirement the inclusion of the active substances in Annex I of the same directive.

How can your consultancy company assist our company in authorising a biocidal product?

Our company is able to furnish specific and updated information on the status of the active substances and on the existing regulations. Furthermore, we offer important assistance for the preparation of a biocidal dossier and we guide your company throughout the whole authorisation process.