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ISTITUTO SUPERIORE DI SANITA'

ISS

The Istituto Superiore di Sanità (ISS) is the Italian National Institute of Public Health, carrying out scientific-technical Research for the Italian National Health System, providing control and advice in Public Health.

Lobbying Activity

Response to Technical specifications for the preparation of risk management plans to ensure the safe reuse of treated waste water in

8 Feb 2024

Concerning Annex p. 3/4 and p. 5/6, we recommend more specific indications concerning the management of the scenario where reclaimed water feeds an existing open-channel irrigation system, especially if quality class A or B reclaimed water feeds an open-channel irrigation system of flowing river water. Specifically, we recommend adding details on how to assess (point 5 of letter (A) Key elements of risk management of Annex II of EU Regulation 741) uncontrolled blending (in quality and quantity) of water from different sources (including reclaimed water) flowing in open-channel irrigation systems, including risks related to seasonal variabilities, extreme climate events free access of animals to the open-channels.
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Response to Fitness Check on endocrine disruptors

30 Jun 2019

A fitness check on current legislation can support a a long-term holistic approach to deal with EDs in a consistent and scientifically robust way. On the other hand, it must not delay taking actions that can already be carried out under current legislastive frameworks (e.g. biocides, pesticides). A cormerstone is the principle "one substance, one toxicology", i.e., dealing with the ED-related hazard of a given substance with the same criteria across different regulatory fields (e.g., substance X is identified as an ED whether it is used as food additive, cosmetic ingredient, feed additive etc.).. The whole process of ED assessment must be based on scientific evidence, duly and trasparently balanced with the appraisal and weighing of uncertainties and the use of precautionary assumptions.. ED assessment is burdened by important knowledge gaps (e.g., definition of a "threshold", screening of diabetogenic/obesogenic ED, etc.); thus feed-back from robust, targeted research are an essential part for developing an effective regulatory framework. In addition the process should give due attention and resources to the identification of safe alternative substances and environmental remediatio; indeed these may become top-priority issues in the next. future. It is recognized the importance of the dialogue between stakeholders and the European Commission; in order to be effective this should include a permanent, structured system of information exchange and consultation. The document does not make any mention of circular economy,, which could be important for minimising the exposure to ED: it would be important to link the EU strategy on ED to the Circular Economy Action Plan and the Plastic Strategy. The European strategy on EDs should have an international dimension in order to effectively protect health and environment, as well as the protect the European production model of foods and goods. Thus, the fitness check should also include initiatives toward the EU partners in the global market (e.g., BRIC Countries, USA), aiming at a more proactive international role for the EU,
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Response to Codes for the designation of Notified Bodies in the field of medical devices and in vitro diagnostic medical devices

24 Oct 2017

The proposal attached introduce changes to the draft of the implementation act that may facilitate the process of qualification of the of the Notified Bodies, with a minimal “word changing” in order to consent a rapid approval of implementation act possibly without any delay. We think that the goal of NBOG codes is the clear identification of the expertise needed to the NB in order to perform the evaluations; for this scope is necessary to avoid an excessive fragmentation in a number of codes that identify different devices for those is required a unique common evaluator expertise. We think also that the essential expertise for the evaluators are better described in part II (excluding table 2 that should be deleted) The proposal below is a re-elaboration from the file sent on October 10/2017 by Dr V. Houdry to IVD-TG.
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