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21 November 2018

Revision of the Carcinogens Directive: the European Parliament wants better protection for health workers from exposure to hazardous drugs

On 20 November the European Parliament’s Social Affairs Committee adopted amendments in the third revision of the Directive on the protection of workers from carcinogens and mutagens.
The amendments were adopted with a majority of around 85 % and were the result of compromises negotiated between Parliament’s various political groups.

Parliament invites the Commission to take a legislative initiative before the end of 2019 on drugs that are carcinogenic or mutagenic for workers in the health sector who come into contact with these. The Commission should either compile a list of hazardous drugs so that these can be included within the scope of the Directive, or it should propose another more appropriate legislative instrument. This is an extremely important issue. Current estimates suggest that, in Europe, around 12.7 million people working in the health sector are potentially exposed to such drugs, which are particularly used in chemotherapy, including over 7 million nurses. The vast majority of those occupationally exposed are women as they predominate in the health sector, particularly in nursing. As a result of this amendment, better prevention of occupational cancers among female workers will finally make it onto the European legislative agenda, given that the prevention of occupational cancers has traditionally been focused on professions and sectors in which men predominate.

Parliament also proposes clarifying the Directive’s scope. The amendment also calls for improved cooperation with the International Agency for Research on Cancer (IARC). This amendment should enhance legal certainty and complementarity between the legislation on worker protection and that regulating the chemicals market.

Parliament also intervenes in the debate on transparency with regard to the level of risk associated with occupational exposure limit values (OELVs). It calls for the precautionary principle to be applied and for an OELV never to be associated with a risk exceeding 4 cases of cancer per 10 000 workers exposed throughout their working life.

One amendment on cadmium is more contentious. The Commission proposes an occupational exposure limit value of 0.001 mg/m³. This proposal has faced a lobbying campaign by various industrial sectors. Parliament proposes allowing Member States to choose between two legislative options: either they comply with the OELV of 0.001 mg/m³, or they can adopt a less protective OELV of 0.004 mg/m³, provided that they implement biological monitoring with a limit value for the concentration of cadmium in urine. There is no evidence that these two options ensure an equivalent level of protection for exposed workers. The scope of this amendment is even more difficult to interpret as the two OELVs are not formulated in the same terms: the respirable fraction of cadmium would be calculated for the second option, whereas the inhalable fraction would be calculated for the first option.

According to Laurent Vogel, an ETUI researcher: “The amendments generally confirm the active and positive role played by Parliament in the revision of EU legislation on cancers at work. However, it does not make sense to introduce biological limit values on a case-by-case basis, without having previously adopted a clear legislative framework for the use of those limit values. In all cases, if any biological limit value is exceeded, this should result in the employer being obliged to adopt a plan to minimise exposure and in guarantees being put in place to prevent discrimination, in terms of employment and working conditions, against those workers for whom the limit value has been exceeded. It is vital to keep the focus on primary prevention, rather than organising a rotation of those exposed”.

The other OELVs proposed by the Commission concern beryllium, arsenic acid, formaldehyde and MOCA (4,4'-Methylene-bis(2-chloroaniline)). As regards these substances, Parliament supports the Commission’s initial proposal. However, it advocates a longer transitional period for formaldehyde exposure in funeral and embalming activities.

The next stage in the adoption of this third revision will be the negotiation between Parliament and the Council of the European Union. The final content of the Directive will depend on the agreement reached by the two co-legislators. This negotiation will start soon under the Austrian Presidency of the EU Council. The Directive is likely to be adopted in the next few months.

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