On Oct. 27th , 2015 Bio Basic Europe took part to the event organized by Istituto Superiore di Sanitΰ regarding news, updates and deadlines on the subject of biocides. During the day it has been discussed about the category of medical and surgical devices (MSD) giving particular attention to the period of transition that considers a reclassification of the products as biocides. During the conference, it resulted that the European Union is passing through a period of transition as regards biocides, which in Italy affects also the category of Medical-Surgical devices (MSD).
In Italy, the 98/8/EC Directive that deals with biocides launch onto the market, implemented with the Legislative Decree No 174/2000, it has been replaced by the 528/2012 UE Regulation (that came into force on July 17th, 2012 and became applicative from Sept. 1st , 2013) through a period of transition for some dispositions.
It is mentioned below a brief summary of what has been treated in order to determine in a clear and concise way the present and future situation.
A biocide, as defined by the EU Regulation No 528/2012, is:
Any substance or mixture in the form provided to the consumer, composed by contains or substances able to generate one or more active ingredients, with the aim of destroying, eliminating and annihilating, impeding the action or practicing any other control effect on any noxious organism, by using any mean, different from the mere physical or mechanic action.
Any substance or mixture, generated from substances or mixtures that do not fall within the first category, used with the aim of destroying, eliminating and annihilating, impeding the action or practicing any other control effect on any noxious organism, by using any mean, different from the mere physical or mechanic action.
Also a treated item that has a primary biocide function is considered a biocide.
Biocides include 22 types of products (PT) divided into four groups, with the description of each type basing on its activity ad usage:
Group 1: General disinfectants and biocides (PT 1, 2, 3, 4 and 5)
Group 2: Preservatives (PT 6, 7, 8, 9, 10, 11, 12 and 13)
Group 3: Control of noxious animals (PT 14, 15, 16, 17, 18, 19 and 20)
Group 4: Other biocides (PT 21 and 22)
The Regulation BPR aims at improving the free movement of biocides within the European Union, assuring, at the same time, a high level of protection for both human, animal and environmental safety through the principle of prudence so that the production and the availability on the market of actives and biocides do not lead to adverse impacts on human and animal health or unacceptable effects on the environment.
In order to remove, as much as possible, the obstacles for biocidal products trading, the Regulation harmonizes norms concerning the approval of active substances, their availability on the market and usage, including norms related to the mutual acknowledgement of authorization and the parallel trade.
The Regulation disciplines as follows:
a) The creation, at a European level, of a list of approved active substances for biocides;
b) The authorization for biocidal products referring to the 22 types of biocides (PT);
c) The mutual legitimacy of authorizations within the European Union;
d) The market availability and the usage of biocides in one or more EU Member States;
e) The launching onto the market of treated items.
In the light of the European harmonization, Italy considers necessary to reclassify the present medical-surgical devices (ruled by the RPD 392 of Oct. 6, 1998 and by the Ministry of Health Provision of 1999) and many other products that, although they have the intended use of a biocide, at present they are placed into the market without any authorization (Free-Sale Products FSP).
For MSD (medical-surgical devices) are meant all those products that show on the label an activity attributable to the following definitions, as showed in the article 1 of RPD 392 of Oct. 6, 1998:
disinfectants and substances marketed as germicides or bactericides ; insecticides for domestic and civil use; insect repellents; rat poisons for domestic and civil use.
MSDs, in order to have them launched onto the Italian market, must be authorized by the Ministry of Health within the meaning of the RPD 392 of Oct. 6th 1998. The conversion of MCDs into biocides sticks to the following categorization:
disinfectants and substances put onto the market as germicides or bactericides (PT1, 2, 3, 4, 5);
insecticides for domestic and civil use (PT18);
insect repellents (PT19);
rat poisons for domestic and civil use (PT14).
During the Congress, thanks to the contribution of the Italian Authorities, many issues have been dealt with by examining what it has been written in the BPR Regulation as regards the present and future classification of biocides and MSD products, the labeling and the impact on biocides of the Regulation (EC) No 1272/2008 (CLP), the procedures of authorization and trading of a biocidal product according to what is needed by the Regulation, giving a particular attention to the article 95 of BPR (Transitional measures concerning the access to the active substance dossier) and the application of the IUCLID and R4BP systems for the national authorization of a biocide substance.
In the light of what has been described, Bio Basic Europe is able to provide consultancy services and to evaluate the product in all its phases, from the presentation of the dossier to get the registration in the EU, to the labeling revision, till the notification to the ISS- Archive for Dangerous Preparations.
Particular attention is given to the identification of borderline products in order to determine the correct admission to their category of expertise.
The contact persons are:
- Angelinetta Dr. Claudio, Technical Department Manager
Tel. +39 02 4155729
- Busoli Badiale Dr.ssa Silvia, Medical Device Department Responsible
Tel. +39 02 4155729
Our best wishes,
Dr. Umberto Pianca
Bio Basic Europe