The REACH Regulation contains two mechanisms by which the Commission can adopt regulatory measures that determine acceptable limits of exposure to chemicals: Title VII on authorisation and Title VIII on restrictions. These can concern workers and/or the general public.

Setting acceptable limits is straight-forward when a safe limit of exposure can be determined where a substance is expected to have no adverse effects (the so-called DNEL). The situation is more difficult for substances for which no thresholds can be determined (e.g. many carcinogens).  

For example, under the socio-economic route of the authorisation process (which is applicable to non-threshold substances listed in Annex XIV to REACH), the Commission can only grant authorisation if the applicants for authorisation demonstrate that the remaining risks from continued use of the substance to workers (or where relevant consumers) and the environment are outweighed by the socio-economic benefits of continued use and that there are no suitable alternatives. With such uses workers using these substances will be exposed to a certain level and the related risk, at individual workplaces covered by that authorisation, is approved as acceptable by the Commission.

On the other hand, binding occupational exposure limits for non-threshold carcinogens may be set in the framework of Directive 2004/37/EC: the Commission proposes such limits to the Council and the European Parliament, who take the final decision in a full legislative procedure.

Both processes may concern the same substances, but the actual exposure levels approved as acceptable under Directive 2004/73/EC and REACH authorisation, respectively, may differ, leading to different levels of risks and therefore a different probability of cancer for a worker exposed to the substance. Furthermore, non-threshold carcinogens for which no occupational exposure limits have been set by the Parliament and the Council under Directive 2004/73/EC may be subject to REACH authorisation. Consequently, the Commission (albeit with an opinion of the Member States in the REACH Committee in examination procedure) would accept the level at which workers are exposed to these substances following the set of particular risk management measures and operational conditions linked to specific authorised uses and workplaces. Moreover, (different) national occupational exposure limits might have been set for such substances by the Member States.

As for the exposure of the general public, no EU legislation comparable to Directive 2001/73/EC exists. However, several restrictions in REACH or in other product legislation (such as toys) set out limits for exposure (either through limit values for the presence of a substance in articles or through migration limits). However, at EU level no general reflection on what level of risk to the general public is acceptable seems to have taken place.

In the recent proposal for a binding occupational exposure limit value for chromium VI, the value of 25 micrograms/m³ in air was derived for chromium VI on the basis of an excess cancer risk for workers of 2-14 : 1,000, whereas some Member States discuss acceptable risk levels for workers developing cancer of 4 : 10,000 (interim level) and 4 : 100,000 (2018), as well as whether these risk levels will always have to be substance-specific case-by-case decisions.

For consumers, some Member States advocate a level of 1 : 1,000,000 as an acceptable cancer risk.

It was, therefore, necessary to discuss how to determine acceptable levels of exposure and related risks for workers and the general public in order to have a coherent approach for different substances. The workshop examined existing procedures and methodologies in the Member States and at European level.

Date and venue

The workshop was organised by the Commission on 22 November 2016 in Brussels, Albert Borschette Conference Centre (rue Froissart 36, 1040 Brussels).

Agenda

Workshop agenda

Web-streaming

The workshop was web streamed live during the whole session.

Watch the workshop web-stream
Listen to the AM audio recording
Listen to the PM audio recording

Presentations

• Russel Clarke
• Stefan Engel
• Corrado Galli
• Fritz Kalberlah
• Pelle Moos
• Bert Pol
• Aart Rouw
• Demi Theodori
• Martin Wieske

Contact

For questions about the workshop, please contact: GROW-D1@ec.europa.eu