The difficult transition from presidi medico chirurgici (PMC) to biocides is essentially due to the need to develop European legislation able to properly regulate all those products falling within the classification of biocides and that, until now, have been subject to different regulations depending on the country of interest. Once the review program is fully implemented, the application of Regulation 528/2012, and subsequent modifications, will allow for greater control of the active ingredients used in the preparation of biocidal products and, at the same time, facilitate their commercialisation in the European market.
With Directive 98/8/EC a program of ten-year review of all the active ingredients on the market before 14 May 2000 has been established in order to identify and re-group those substances whose use in the preparation of biocides is considered appropriate.
The first phase of the program provided for the identification of the active ingredients on the market on the 14 May 2000 (a date chosen according to Directive 98/8/EC of the 14 May 1998which gave Member States two years for its implementation at national level) explaining the procedure to be followed for that purpose. Any active substance that does not enter in the first phase of the review should be assessed as a “new substance”.
The active ingredients subject to the review program and those selected following a favourable assessment, have been grouped in certain Annexes to Directive 98/8/EC and various subsequent regulations, continuously updated by the decrees of inclusion and exclusion:
- Annex I (containing all active ingredients deemed suitable for the preparation of biocides);
- Annex IA (containing non-hazardous active substances that can be used for the preparation of “low risk biocidal products”);
- Annex IB (reporting the “known substances”, or “those whose main use is not for the purpose of biocides but who have some minor uses as biocides”);
- Annex II (containing all the substances still under review).
The Union list has been introduced with the entry into force of Regulation (EU) No. 528/2012, which contains the active ingredients approved for use in biocidal products. Annex I of that Regulation lists the active substances used in biocidal products that may be authorised under the simplified procedure.
Following Directive 2009/107/EC, the revision program was extended until 14th of May 2014 in order to allow for its completion. This deadline has been further postponed to December 31st 2024 with the Commission Delegated Regulation (EU) No. 736/2013.
This situation has lead to the occurrence of a transition period in which national legislation overlaps with EU regulations. The active substances in Annex II of Commission Delegated Regulation (EU) No. 1062/2014 (repealing and substituting Regulation (EU) No. 1451/2007) can be used in products for which the marketing authorisation is governed by national laws.
In the event that the active ingredients are included in the list of those approved, the product must be authorised as a biocide. If only one of the active ingredients contained in a given preparation is not included in that list, the product may not be authorised as a biocide.
The registration of a product as a PMC, in the case of the Italian legislation, is only possible for a preparation containing an active substance listed in Annex II for the product type (PT) of interest and is valid until the date of inclusion of the active substance in the list of those approved. Products containing active ingredients which have been excluded or for which by the date of the end of the review no evaluation by any Member State has been requested, are automatically excluded from the market.
For the purposes of the marketing authorisation, it is advisable to initially evaluate what the active ingredients are that can be used for the preparation of biocides and which PT may be taken into consideration for each active ingredient.