New directive (UE) 2022/431: how title IX hazardous substances changes and the multiple consequences
Keywords:reprotoxic substances, European Directive, chemicals, gender, occupational exposure, hazardous medicinal products
Directive 431/2022 amending directive 2004/37/EC will be implemented on 5 April 2024. The title changes to "Directive 2004/37/EC of the European Parliament and of the Council, on the protection of workers against the risks deriving from exposure to carcinogens, mutagens or reprotoxic substances at work". In addition to placing the emphasis on reprotoxic substances, the directive introduces changes that will require the implementation of new methods of analysis for environmental and biological monitoring, and new protocols for the medical surveillance and epidemiological surveillance.
In Annex XLIII of the Consolidated Law 4 limit values will be added for 1-methylpyrrolidone, nitrobenzene and bisphenol A (reprotoxic) and for nickel compounds (carcinogenic) and 10 values transferred from Annex XXXVIII because they relate to reprotoxic substances. The field of application of the specific risk assessment envisaged by Chapter II of Title IX is therefore extended to substances and mixtures toxic to the reproductive cycle. In particular, the measurement of airborne substances is expressly required, even for reference periods of fifteen minutes. The laboratories will therefore have to equip themselves with measurement methods compliant with the indications of ANNEX XLI of the TU for these substances, with a sensitivity appropriate to a 15-minute sampling, and also for other substances, whose limit values have not yet been established, but which are carcinogenic or mutagenic or toxic to reproduction, such as for example dangerous medicines.
It is necessary to consider absorption routes other than the inhalation one, such as the cutaneous one, to ensure the best possible level of protection, for which biological monitoring of substances with the skin notation is useful, as expressly suggested for benzene, acrylonitrile and cadmium; laboratories will have to define analysis procedures that include the choice of the most appropriate indicator and matrix.
The Industrial Hygiene laboratories must start a process of verifying the analytical methods for the 14 substances that will enter Annex XLIII and for the biological monitoring of cadmium, acrylonitrile and benzene. It is necessary to promote biological monitoring studies in the general population to provide reference values for the interpretation of the data measured in workers.
The 14 new substances will also have to be taken into consideration in the registers of exposure to carcinogens (and toxic for reproduction) by adapting the IT platform for sending data to INAIL.
The directive also mentions occupational exposure to hazardous drugs (HMP Hazardous Medical Products), including, in this group, those drugs containing substances meeting the classification criteria as carcinogenic, mutagenic or reprotoxic, for which training guidelines will be provided , protocols, surveillance and monitoring, and later also a definition and an indicative list of the drugs themselves or of the substances that contain them.
The Commission has also initiated a process to assess the need to modify the limit value for respirable crystalline silica dust, and then propose, if appropriate, the necessary modifications in a subsequent revision of the Directive.