|
::: European legislation on BIOCIDES
regulations by Francesca Di Renzo
-----------------------------------------------------------
Safety and efficacy of products for
everyday use.
How can we be sure that a common disinfectant
is effective against bacteria
and harmful organisms? The question
is not limited to disinfectants, but also to all
those everyday products whose efficacy and
safety we take for granted. Usually, the guarantee
that a substance has the properties described
on the label, is as a result of the existence
of regulations governing the marketing
of so-called “Surgical Medical Aids” (“Presidi
Medico Chirurgici”). This class of products includes
disinfectants, insecticides and rodenticides,
which need to be nationally authorised
by the Ministry of Health in order to be marketed.
The authorisation is released only after a careful analysis of all documentation and
studies concerning the single products. This,
in addition to providing the end user more
security and peace of mind, also ensures that
a careful assessment of individual products is
carried out at national level.
However, the Italian legislation regulating the
marketing of surgical medical aids will soon
be replaced by European legislation on "Biocides",
whose aim will be to introduce a single
legislation to standardize the behaviour of individual
European countries, while continuing
to ensure a high level of control, security and
efficacy.
The Directive 98/8/EC, which regulates the
marketing authorisation of Biocides, introduced
a ten-year revision programme (subsequently
extended to the 14th of May 2014)
of all active ingredients on the market before
May 14th 2000, in order to identify those substances
whose use for the preparation of biocides
may be deemed suitable and safe.
The substances thus selected are included in
Annexes I and IA of Directive 98/8/EC, while
those still under revision are included in Annex
II of the Directive. Obviously, this careful
assessment and identification of "acceptable"
active ingredients assures the consumer that
the product they purchased actually possesses
these characteristics and properties stated on
the label and, at the same time, guarantees the
absence of highly toxic substances or harmful.
Thus, on the one hand, the consumer’s fears
and doubts decrease, on the other hand the
responsibility and the amount of work of companies
producing biocidal products increase
considerably. The Directive 98/8/EC introduces
further compulsory analysis (toxicological
and ecotoxicological studies) which must be
carried out, in addition to the bactericidal and
fungicidal studies that have already been introduced
by the legislation on Presidi Medico
Chirurgici. This results in a more complicated
and controlled procedure for the marketing
authorisation of disinfectants and insecticides.
In Italy the situation is even more complex, as
both the Italian legislation on Presidi Medico
Chirurgici and the European legislation on
Biocides, needs to be taken into consideration
for the marketing of disinfectants.
Thus, while some active substances are being
reviewed at EU level, and therefore their use
for the preparation of biocidal products is not
allowed, their registration as Surgical Medical
Aids/ Presidi Medico Chirurgici is however
still possible in Italy. If one enters further into the maze of the difficult regulations of biocides,
one notes that the assessment of individual
active ingredients also takes place by
considering the possible intended uses, or, as
described in the legislation, according to the
"product type (PT).
Biocidal products have been subdivided into
23 types of products, for which each active
substance is analysed. At this stage, the only
categories under revision are:
• wood preservatives
• rodenticides
• insecticides, acaricides and products to control
other arthropods
• repellents and attractants.
At this point, it is reasonable to pose the question
of how Italian companies can untangle the
difficult path that goes from Presidi Medico
Chirurgici to Biocides, and to develop and prepare
the necessary documentation to apply for
marketing authorisation, while ensuring the
maximum safety of their products.
|
Add your company to 
Keep up-to-date on latest developments with Dimensione Pulito International ...
Go to reserved area ...