Filippo Busolo – CHEMLER
Over the last two years, two regulatory frameworks of considerable interest have been published concerning chemicals and mixtures containing substances toxic to reproduction (Directive 2022/431 amending the Carcinogens and Mutagens Directive, CMD) and endocrine disruptors (EU Regulation 2023/707, amending Regulation 1272/2008, CLP). Although the two regulatory frameworks are dedicated to obligations for operators, in this article we would like to focus on their impact on the world of paints and varnishes.
Reproductive toxicity refers to adverse effects on the sexual function and fertility of adult men and women, as well as on the development of offspring, which occur after exposure to a substance or mixture.
The CLP regulation classifies these substances into two categories:
– category 1, substances that are known or suspected to be toxic to human reproduction;
• category 1A, substances that are known or suspected to be toxic to human reproduction;
• category 1B, substances suspected of being toxic to human reproduction;
– category 2, substances suspected of being toxic to human reproduction.
In addition, there is a separate hazard category relating to effects on or through lactation.
Similarly, an “endocrine disruptor” (ED) is defined as a substance or mixture that disrupts one or more functions of the endocrine system, causing adverse effects on an intact organism, its progeny, populations or subpopulations.
The mechanisms of ED toxicity can be multiple, the most studied involving binding to one or more receptors for hormones such as, for example, oestrogen, androgen, progesterone, thyroid and vitamin D receptors.
The CLP regulation classifies ED substances for human health into two categories:
– category 1, known or suspected endocrine disruptors to human health;
– category 2, suspected endocrine disruptors to human health.
There are several substances with endocrine-disrupting properties that also have relevant effects on the human reproductive system.
It is worth mentioning that with the publication of Regulation (EU) 2020/878 amending Annex II of the REACH Regulation, requirements for endocrine disrupting properties were introduced into the Safety Data Sheet (SDS) in subsections 2.3 (other hazards), 3.2 (mixtures), 11.2 (information on other hazards) and 12.6 (endocrine disrupting properties).
The adoption of Directive 2022/431, was driven by a growing awareness of the harmful effects that certain chemicals can have on fertility, pregnancy and the proper development of the foetus. Protecting workers from these substances therefore becomes a key priority in order to prevent potential health damage and ensure the well-being of both those involved and future generations. In this context, directive 2022/431 defines «substance toxic for reproduction» as a substance or mixture that meets the criteria for classification as toxic for reproduction category 1A or 1B according to the CLP Regulation.
It also introduces non-threshold reprotoxic substances (those for which there is no safe level of exposure for the health of workers) and threshold substances (those for which there is a safe level of exposure below which there is no risk to workers’ health).
In addition to environmental monitoring, this directive gives a considerable boost to the use of biological monitoring as an effective tool for exposure assessment and in its use to get a true value on the uptake of the substance by workers.
Directive 2022/431 (which will amend for Italy Chapter II of Title IX of Legislative Decree 81/08 on protection from carcinogens and mutagens) has been transposed by the Member States last 5 April.
Substances for which occupational exposure limit values have been included, as they are toxic to reproduction, include, of interest to the paints and varnishes sector, N,N-dimethylacetamide (CAS 127-19-5), N,N-dimethylformamide (CAS 68-12-2), 2-methoxyethanol (CAS 109-86-4), 2-methoxyethyl acetate (CAS 110-49-6), 2-ethoxyethanol (CAS 110-80-5), 2-ethoxyethyl 2-acetate (CAS 111-15-9), 1-methyl-2-pyrrolidone (CAS 857-50-4), bisphenol A (CAS 80-05-7).
At the European level, however, some 150 substances have been identified for which hazardous characteristics for reproductive toxicity are recognised; while the main sources of information on EDs are available from the List of Substances of Very High Concern (Candidate List) and the List of Endocrine Disruptors, both of which can be consulted on the ECHA portal.
As far as the paint and varnish sector is concerned, substances that are toxic to reproduction and endocrine disruptors can be, non-exhaustively, collected as follows:
Organic solvents – Alkylphenols (especially bisphenol A) – Phthalates – Cadmium compounds – Polycyclic aromatic hydrocarbons – Brominated flame retardants – Metals – Biocides.
It will therefore be essential for paint and varnish manufacturers to carefully evaluate the substances and mixtures that are used and placed on the market, in order to comply with these new European regulatory provisions.
