Legislation on carcinogenic

Published on: 01/02/2017
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The Directive 2004/37/EC, in our legislation Royal Decree 665/1997, on carcinogenic and mutagens dates of does more than 20 years. Currently is being object of a deep modification, following the European policy of prevention when dealing with the exhibition to carcinogenic.


First modification

The first Managerial modification (EU) 2017/2398 was published on 27 December 2017 and she has been surpassed to our legislation for the Royal Decree 1154/2020 published on 23 December 2020. The principals changes are:

  • Broad the health surveillance of hard-working people after stopping the exposure at work.
  • It includes works that suppose exhibition to the breathable dust of crystal clear free silica in its annex I.
  • It establishes limits of exhibition for 11 carcinogenic substances more.
  • It modifies the limit value of the monomer vinyl chloride and of the dust of hardwoods ; this last one is reduced to 2 mg/m3 and in a temporary way to 3 mg/m3 until 2023.

Segunda modification

The second Managerial modification (EU) 2019/130 was published on 31 January 2019 and she has been surpassed by the Royal Decree 427/2021 on 15 June 2021. The principals aspects that contributes this modification are:

  • Are added two new points a the Annexe I of processes that they can generate exhibition to carcinogenic substances: Works that suppose cutaneous exhibition to mineral oils previously used in internal combustion engines for lubrificar and to refrigerate mobile elements of the engine and Works that suppose exhibition to issuances of engines diésel.
  • Are added six agents more to the III Annexe: Tricloroetileno, 4.4´Metilendianilina, Epiclorhidrina, Dibromuro of ethylene, Dicloruro of engines ethylene and Issuances diésel.

Third modification

The third Managerial modification (EU) 2019/983 was published on 20 June 2019 and she has been added in our legislation for the Royal Decree 395/2022 published on 25 May 2022.

This modification:

  • It adds five agents more to the III Annexe: cadmium, berylium, acidic arsenic, 4.4´metilenbis (MOCA) and formaldehyde, establishing coincident limit values with the VLA of the National Health and Safety at work Institute (INSST). Only, the cadmium sees reduced its VL by one half and it arranges as a transitional provision its coming into force in the year 2027.

Fourth modification

The fourth Managerial modification (EU) 2022/431 was published on 16 March 2022 and and she has been added in our legislation for the Royal Decree 612/2024 published on 3 July 2024. From now on the Royal Decree 665/1997 is denominated on the protection of workers against the risks related to the exhibition to carcinogenic agents, mutagens or reprotóxicos (CMR) during the work.

Changes more notable of this new modification are:

  • It expands its field of activity to the agents reprotóxicos denominating “Directive 2004/37/EC of the Parliament and of the Board, of 29 April 2004, regarding the protection of workers against the risks related to the exhibition during the work to agents carcinogens, mutagens or reprotóxicos”.
  • It establishes the measures to be adopted to minimise the exhibition to the toxic ones for the reproduction according to if they arrange or not of sure exposure level threshold .
  • It adds fourteen agents more to the III Annexe: nickel acrylonitrile and compounds, for being carcinogenic and twelve agents reprotóxicos, between them frightful bore, nitrobenceno, carbon monoxide.
  • This directive has a statement through which is included in its application field to dangerous medications that they contain in its composition agents CMR (carcinogenic, mutagens and reprotóxicos) categories 1A or 1B, between them cytotoxics.

Fifth modification

The fifth Managerial modification 2024/869 was published on 19 March 2024 and he owes transpose to our legislation before 8 April 2026. The principal modification is the reduction of the allowed levels of environmental and biological frightful bore to the fifth part: 

  • The Limit value environmental happens of 0.15 mg/m3 to 0.03mg/m3.
  • The biological limit value of 70 μg/100ml to 15 μg/100ml, with a period of transition of 30 μg/100ml until 2028. 

This directive also modifies the Directive 98/24/EC on Chemical agents establishing limit values for the diiosocianatos, compounds of broad uses that are classified such as agents sensibilizantes dermal and respiratory.