The Formalin Ban: From Lethal Threat to Unique Opportunity

A variety of crucial issues relating to pathology and laboratory medicine are at the mercy of decisions made by European Union (EU) governing bodies. It is therefore essential to be aware of the mechanisms by which these governing bodies operate so that we can effectively safeguard the interests of both patients and laboratory personnel. An important case in point is the so-called “formalin ban.”

The term itself invokes a lethal threat to the protracted intimacy between formalin and pathology. Indeed, ever since the European Commission issued a resolution that raised formaldehyde’s carcinogenicity and mutagenicity levels in 2014, pathologists have felt uneasy. These changes stirred our fears of an impending mandatory end to the use of our favorite fixative. The uneasiness, however, was unevenly distributed across Europe, with perceived responses ranging from aloofness to overreaction. Once more, the rich diversity of Europe made itself fully apparent. This lack of clarity therefore begs the question: is the so-called formalin ban a myth or a reality?

Sifting fact from fiction

First of all, let’s make it clear that the European Commission has never banned formalin. What the oft-quoted Commission Resolution (EU) No. 605/2014 actually did was change formaldehyde’s classification as both a carcinogen and a mutagen. Specifically, its carcinogenicity was upgraded from category 2 (suspected of causing cancer) to category 1B (it may cause cancer), and its mutagenicity was newly assigned a category 2 (suspected of causing genetic defects) rating.

The EU resolution was issued mainly in consideration of furniture industry workers, who use formaldehyde at extremely high concentrations. It made no allusion to the use – much less the prohibition – of formaldehyde in the healthcare sector, where the concentrations used are much lower. In line with this, discussions in the European Parliament took place primarily in the context of the Employment and Social Affairs Committee (EMPL), and only secondarily in the setting of the Environment and Public Health Committee (ENVI).

So where did the supposed formalin ban in the healthcare sector come from? Seemingly, the formaldehyde classification changes contained in Resolution (EU) No. 605/2014 prompted occupational safety departments and trade unions to promote an across-the-board formalin ban, whose aim was to protect workers involved in any formalin-using task. Depending on the various countries’ management models, however, the possibility of truly implementing a formalin ban in the healthcare sector ranged from nil (hence the cavalier attitude of some pathologists) to overwhelming (hence the alarmed reaction of many others). At the extreme end of the spectrum, countries such as France did, in fact, enact formalin-banning legislation with significant repercussions for the practice of pathology.

Pathologists strike back

Despite these differences among countries, common interest demands concerted action in an intertwined Europe where any issue rapidly spreads far and wide. Consequently, in 2016, the European Society of Pathology (ESP) and the Union of European Medical Specialists (UEMS) Section of Pathology issued a joint statement that contained stern warnings. For example, “the banning of formalin cannot be considered in the European health system without generating major harm to the quality of diagnosis for patients.”

Thanks mainly to the efforts of Bernard Maillet, Treasurer of the UEMS, additional support for the ESP-UEMS joint statement was obtained from a variety of European medical organizations. These included the Association of European Hospital Physicians, the European Council of Medical Orders, the Standing Committee of European Doctors, the European Medical Students’ Association, the European Federation of Salaried Doctors, and the European Union of General Practitioners (1).

Additionally, many people took strategic action that would break the stalemate and eventually lead to proper recognition by the European Parliament of formalin’s role in medicine. This action was orchestrated by a number of individual pathologists – including ESP councilors, UEMS delegates, and presidents of pathology national societies – and their countries’ representatives in Strasbourg. As a result, many members of the European Parliament (MEPs) – particularly those in the EMPL and ENVI committees – were made aware of the inescapable need for formalin in patient care.

An increasing amount of empathy and knowledge accompanied the subsequent discussions of the successive draft amendments, which were presented to the EMPL and ENVI committees by Spanish MEPs Javi López and Soledad Cabezón. These two members were extremely responsive to my persistent formalin-saving entreaties, which were deftly mediated by Jaime Medrano from the International Department of Spain’s Organización Médica Colegial.

The long march to a formalin-saving amendment

The following statement is part of one of the many draft amendments advocating formalin’s unimpeded but judicious use: “Formalin is routinely used in healthcare facilities for standardized fixation of patients’ tissue specimens, such as biopsies. The pathologist’s diagnosis of a variety of diseases, including cancer, is based on the recognition of characteristic microscopic findings in formalin-fixed tissue. Moreover, criteria for the evaluation of diagnostic, prognostic, and predictive biomarkers have been progressively developed [over] many years, also in reference to formalin-fixed tissue. Validation of other fixatives putatively able to replace the crucial role of formalin in patients’ care will require a number of years. Consequently, the healthcare sector must be explicitly exempt from a formalin ban that would result in multiple diagnostic errors and serious harm to countless European patients. Healthcare facilities must implement appropriate measures for keeping formalin exposure of their personnel within safe limits.”

After multiple attempts and much debate, the EMPL Committee finally approved a compromise amendment in November 2018. Italian MEP Laura Agea was instrumental in reaching that groundbreaking amendment. The latter read as follows: “Formaldehyde fixatives are routinely used in European healthcare centers for the standardized fixation of tissue samples, given their convenience in handling, high degree of accuracy, and extreme adaptability, which have not been reached by any other group of fixatives so far. As a result, a pathologist’s diagnosis of a variety of diseases, including cancer, is based on the recognition of microscopic traces in tissue fixed in a formaldehyde fixative. The concentrations of formaldehyde used in healthcare are minimal in comparison with those used in industry and, while healthcare centers in the Union should take all appropriate measures to keep formaldehyde exposure among their staff within safe limits, the healthcare sector should have no difficulty to respect the limit value set in the present Directive.”

Unique opportunity

Finally, on March 27, 2019, the issue was settled by a European Parliament resolution declaring: “Formaldehyde fixatives are routinely used in the healthcare sector across the Union because of their convenience of handling, high degree of accuracy, and extreme adaptability. In some Member States, it is foreseeable that the healthcare sector will have difficulties in complying, in the short term, with a limit value of 0.37 mg/m³ or 0.3 ppm. It is therefore appropriate to introduce for that sector a transitional period of five years, during which the limit value of 0.62 mg/m³ or 0.5 ppm should apply. The healthcare sector should, however, minimize exposure to formaldehyde and is encouraged to respect the limit value of 0.37 mg/m³ or 0.3 ppm during the transitional period where possible.”

Following approval by the EMPL Committee, European Parliament Plenary Session, EU Council, and European Commission, the Member States have been informed of the EU’s new position on formalin use and their obligation to comply. The EU’s recognition of the necessity and virtues of formalin, coupled with the simultaneous setting of limit values to minimize exposure, is a welcome conclusion to a five-year-long saga. The lethal threat of a formalin ban has transformed into a unique opportunity to enhance the safety and visibility of pathology.

Such a happy outcome was only made possible by the positive response of our MEPs and the collective and personal efforts of the many European pathologists who cared enough to venture into the intricate maze of EU affairs. For the sake of European patients, let’s keep engaged!