Carcinogens (EU)

2019 saw the second and third revisions of the European Carcinogens and Mutagens Directive Annex III (the list of substances for which exposure limits apply) agreed. I blog posted about the changes a while back, check the category Chemicals.

Member states have until dates in 2021 to implement the revisions in national law.

Ireland has now updated its local law, and Email Alerts to subscribers with Ireland (ROI) systems will see details in their November & December Email Alert dispatching tomorrow. Law Checklists are also being updated.

Subscribers with other EU26 countries in their systems will see details in their next 6-month Email Alerts. Law Checklists are being updated now.

Subscribers with UK nations in their systems will see advisory details in their January 2020 Email Alerts dispatching at the end of January 2020. UK Law Checklists will be updated ONLY if UK national law is updated. Note : UK includes Northern Ireland.

Brexit : since these revisions were agreed before the Exit day, it is expected (but not confirmed) that they will be applied in UK national law. But as a Directive, the Carcinogens and Mutagens Directive is not a Retained EU Law, and there are no Brexit Laws applicable.

Carcinogens and Mutagens (EU)

I posted in 2017 about new developments with the European Carcinogens and Mutagens Directive (2004/37/EC). Find this in the Chemicals archive on this Blog.

A new proposal is now made (the third legislative amendment since the start of this European Commission. Note : the Directive was already amended before these current developments). This third amendment is here. In total, there are three current amendments outlined in this Blog post.

Apart from the third amendment, two previous legislative amendments were proposed by the Commission, in May 2016 and January 2017. Together they proposed limit values to 20 carcinogens. The first of these proposals (the 2016 one) was adopted by the co-legislators as Directive (EU) 2017/2398 (which is an amendment to Directive 2004/37/EC).

NB : Member States have until the start of 2020 to implement Directive (EU) 2017/2398.

The first revision adds 13 new or stricter exposure limits to the EU Directive. Respirable crystalline silica dust, benzene and vinyl chloride monomer are three of the substances affected.

The second proposal for legislative amendments (the 2017 one) is currently being discussed by legislators. The second revision sees new binding occupational exposure limits (Boels), and in some cases skin notations set for:

trichloroethylene;

4,4-methylenedianiline;

epichlorohydrine;

ethylene dibromide;

ethylene dichloride; and

mixtures containing benzo(a)pyrene.

As part of this latest (third) amendment to the CMD, five carcinogens of high relevance for the protection of workers are selected:

• Cadmium and its inorganic compounds;

• Beryllium and inorganic beryllium compounds;

• Arsenic acid and its salts, as well as inorganic arsenic compounds;

• Formaldehyde;

• 4,4′-Methylene-bis(2-chloroaniline) (MOCA).

Background

The EU principles of worker protection from carcinogens are laid out in the over-arching Occupational Safety and Health (OSH) Framework Directive 89/391/EEC and those Directives specifically dealing with chemical risks – notably the Chemical Agents Directive (CAD) and the Carcinogens and Mutagens Directive (CMD).

Under the OSH framework, risks to the safety and health of workers must be eliminated, or, if total elimination is not possible, reduced to a minimum. Employers must identify and assess risks to workers associated with exposure to specific carcinogens and mutagens at the workplace, and must prevent exposure where risks occur. Where this is technically possible, substitution with a non- or less-hazardous process or chemical agent is required. In cases where such substitution is not possible, chemical carcinogens must, as far as it is technically possible, be manufactured and used in a closed system to prevent workers’ exposure. Where this is not possible either, worker exposure must be reduced to as low a level as is technically possible.

The Carcinogens and Mutagens Directive (CMD) sets a number of general provisions to prevent or reduce exposure for all carcinogens and mutagens falling under its scope. In addition to these general minimum requirements, the CMD indicates occupational exposure limit values (OELs) for all those carcinogens or mutagens for which this is possible, as an essential means to protect workers.

From time to time, there are revisions proposed to the CMD (and the CAD).

Email Alerts

Email Alerts are issued closer to the date when Member States must implement the changes to the EU law. Otherwise, please continue to follow this Blog.

Brexit

The first of these amendments must be implemented by early in January 2020. It is not known if the UK will implement this amendment.

Carcinogens & Mutagens (EU Law)

An amendment to European Directive 2004/37/EC (Carcinogens and Mutagens) is expected to be adopted in February 2017. This amendment will set exposure limits for a further 11 carcinogens in addition to those covered by the existing 2004 directive. These are: 

* respirable crystalline silica dust

* 1,2-Epoxypropane

* 1,3-Butadiene

* 2-Nitropropane

* acrylamide

* certain chromium (VI) compounds

* ethylene oxide

* o-toluidine

* refractory ceramic fibres

* Bromoethylene

* Hydrazine

The amendment will also revise the limits for vinyl chloride monomer and hardwood dusts in the light of more recent scientific data. 

There will be minimum requirements for eliminating and reducing all carcinogens and mutagens. In line with the existing 2004 Directive, Employers will have to identify and assess risks to workers who are associated with exposure to specific carcinogens (and mutagens), and prevent exposure where risks exist. 

Substitution by a non or less-hazardous process or chemical agent will be required where this is technically possible. 

Email Alerts will be sent out. The Amendment proposal is here