Prevención del cáncer
Según la Organización Mundial de la Salud, cada año 3,7 millones de europeos son diagnosticados con cáncer y 1,9 millones mueren de esta enfermedad. Según las estimaciones de la hoja de ruta sobre carcinógenos, la exposición a sustancias químicas cancerígenas en el lugar de trabajo representa 120 000 de los diagnosticados con cáncer y 80 000 de las muertes.
Con las medidas preventivas pertinentes, más del 40% de todos los casos de cáncer podrían evitarse. En febrero de 2020, la Comisión Europea puso en marcha la hoja de ruta hacia el Plan de Lucha contra el Cáncer de la UE que introducirá medidas para prevenir, detectar y tratar el cáncer en la UE al tiempo que reducirá las desigualdades en materia de sanidad entre los Estados miembros y dentro de los mismos.
La prevención es la piedra angular del plan. Por consiguiente, la ECHA apoyará la iniciativa y contribuirá al logro de sus objetivos protegiendo a los ciudadanos y a los trabajadores agilizando la gestión de riesgos de las sustancias químicas potencialmente cancerígenas.
Carcinogens are chemicals that may cause cancer. This happens because the chemical disturbs the normal functioning of the cell it interacts with. Exposure to carcinogens can happen, for example, when they are breathed in or come into contact with the skin.
Some carcinogens are more harmful than others. The Classification, Labelling and Packaging (CLP) Regulation divides them into three categories:
- 1A – chemicals that are known to cause cancer to humans;
- 1B – chemicals that are presumed to cause cancer to humans; and
- 2 – chemicals that are suspected of causing cancer to humans.
Although classified as known or presumed to cause cancer to humans, chemicals such as benzene, cadmium, cobalt, tricholoroethylene, formaldehyde and hexavalent chromium and its compounds are still present or being used in European workplaces.
In addition to direct exposure to the chemical itself, certain processes may also expose people to carcinogens – this can happen, for example, when breathing in fine dust from hardwood at sawmills or inhaling fumes of polycyclic aromatic hydrocarbons (PAHs) from asphalt roads at roadworks.
ECHA provides information to decision makers so they can take action to remove chemicals that may cause cancer from the market or control their use. The Agency also contributes to protecting human health and the environment from chemicals that are carcinogenic, mutagenic or toxic to reproduction (CMRs) through different legislative processes.
Dossier evaluation under REACH
ECHA checks that companies submit the information required by REACH when they register their chemicals to gain access to the EU market. This information is used to determine if a chemical could be harmful for human health or the environment, and helps decision makers to manage the possible risks.
Substances of very high concern (SVHCs) under REACH
CMRs are SVHCs that should progressively be replaced by less harmful alternatives or technologies. Member States and ECHA, at the request of the Commission, are responsible for proposing chemicals to be identified as SVHCs.
In October 2020, the Candidate List of SVHCs contained altogether 209 substances – 102 suspected to be carcinogens, mutagens or both. From this list, the Commission selects chemicals to be placed on the Authorisation List.
Harmonised classification and labelling
CMRs should have harmonised classification and labelling (CLH) throughout the EU. This means that companies that supply the substances onto the EU market have to classify and label them in the same way – as well as any mixtures containing the substances – to ensure a high level of protection for people.
Chemicals classified throughout the EU as causing cancer (categories 1A and 1B) are not allowed to be sold to consumers. But mixtures containing these chemicals can still be sold to consumers as long as their concentration in the mixture is below given limits.
In September 2020, 1 191 chemicals had a harmonised classification and labelling for carcinogenicity or mutagenicity.
Companies need to apply for authorisation if they want to continue using carcinogens and other SVHCs that have been added to the Authorisation List. The authorisation can only be granted by the Commission if the benefits of continued use are higher than the remaining risks and no suitable alternatives are available for the applicant.
The following carcinogens need authorisation before they can be used:
- Hexavalent chromium including many of its compounds;
- Lead chromate pigments;
- Diarsenic trioxide and arsenic acid;
- 1,2-dichloroethane (EDC);
- Technical MDA; and
- Coal tar pitch, high temperature (because they contain polycyclic aromatic hydrocarbons (PAHs)).
Due to the authorisation requirement related to these substances, it is estimated that some 3 000 workplaces in the EU have reduced risks to workers either by containment or by replacing the chemicals with safer alternatives.
Chemicals that cause cancer are banned in the EU as substances on their own and limited in mixtures intended for consumer use. Once a chemical gets a harmonised classification as a known or presumed carcinogen, the European Commission adds it to the list of REACH restrictions through a fast-track restriction procedure. The procedure also allows the Commission to tackle carcinogens in articles – an example of this is the restriction of 33 CMRs in clothing, textiles and footwear, which has applied since November 2020.
In addition, all types of CMRs can be restricted through the normal REACH restriction process, which includes an assessment of risks by ECHA’s Committee for Risk Assessment (RAC) and of impacts to society by the Committee for Socio-economic Analysis (SEAC).
There are already restrictions of cancer-causing chemicals in place under REACH including:
- Eight PAHs restricted in rubber and plastic articles, such as sports equipment, household utensils, clothing and footwear since January 2010; and
- 1,4-dichlorobenzene restricted in toilet fresheners since June 2015.
In addition, there are several restrictions being processed. ECHA, Denmark, Italy and Norway have proposed to restrict more than 4 000 hazardous substances, including CMRs, used in tattoo inks and permanent make-up. The EU Member States supported the restriction proposal, which is currently being scrutinised by the European Parliament and the Council. The Commission is expected to adopt the restriction by the end of 2020.
The proposal by the Netherlands to limit eight PAHs in rubber granules used, for example, on artificial turf pitches and playgrounds is also being discussed by the Member States in the Commission. The aim of this restriction is to ensure that the cancer risk from PAH exposure remains at a low level for those that come into contact (by inhaling or touching) with the granules and mulches. This includes footballers and children playing on the pitches or playgrounds and workers installing and maintaining the surfaces.
ECHA’s proposals to restrict five cobalt salts, and formaldehyde and formaldehyde releasers in consumer articles have been assessed by RAC and SEAC and the proposals together with the committee opinions have been sent to the Commission for decision making.
Occupational exposure limits (OELs)
OELs are introduced for carcinogens and mutagens to protect the health of workers in the EU. OELs are mainly intended to prevent workers from inhaling chemicals. It is estimated that OELs can save the lives of more than 100 000 workers over the next 50 years.
RAC has provided the Commission with scientific opinions on OELs since 2019. In June 2020, it adopted opinions on lead and its compounds as well as on diisocyanates.
Already in 2017, RAC developed scientific assessments on the OELs for the five following carcinogenic substances in a pilot project requested by the Commission:
- arsenic acid and its inorganic salts;
- nickel and its compounds; and
As ECHA had already worked on the authorisation applications of MOCA and arsenic acid, it could quickly propose the relevant OELs.
To identify chemicals of concern (including CMRs) more quickly, ECHA has started to examine chemicals in groups, instead of looking at individual substances. This approach is expected to speed up the risk management of chemicals and help avoid regrettable substitution.
ECHA's database on chemicals
ECHA also maintains the world’s largest database on chemicals. The possible properties of concern – for example, if they are CMRs – are indicated for each chemical in the database.
- Dossier evaluation
- Substances of very high concern identification
- Candidate List of substances of very high concern for Authorisation
- Harmonised classification and labelling
- REACH authorisation process
- Authorisation List
- REACH restriction
- Occupational exposure limits
- Addressing substances of concern
- Information on chemicals