Phase-out substances that should be substituted

PBT substances

Chemical substances that are persistent, bioaccumulating and toxic are denoted PBT and are among the most troublesome substances there are for the environment.  

P: Substances with long half-life are called persistent. “Half-life” means the time it takes for the amount of a certain substance to be halved in the environment (soil, sediment, water). The worst, most persistent substances are in principle not degraded at all, and can be found everywhere, from deep sea to groundwater. Persistent substances have even been found to be transported by the air to the polar areas.

B: Bioaccumulating substances are taken up by cells and accumulate in tissue and organs, often because they are fatty-soluble and thus not secreted to urine. 

T: Toxicity is assessed using tests on model organisms representing different trophic levels in the environment; from plants to bacteria, algae, daphnia, fish, birds and sometimes insects, such as bees. Often the lethal concentration is studied, but also other parameters can be interesting, for example the photosynthetic capacity of algae.

vPvB: Very persistent and very bioaccumulative substances, vPvB, are assessed with respect to the precautionary principle, and should be phased out since they have a high tendency to accumulate in organisms and environment.

For a substance to be classified as PBT, it needs to meet all three criteria.

Read more about the criteria for classification of PBT substances on the Swedish Chemicals Agency´s webpage. 

CMR substances

CMR substances are very hazardous for human health. CMR stands for carcinogenic, mutagenic (genotoxic) or toxic to reproduction.  

CMR substances may cause permanent damage also to lives not even born, also at a low dose, and it is often not possible to determine a safe specific limit value. 

C: Carcinogenic substances may cause cancer, either by damages to the DNA (mutagenic) or via indirect processes, such as effects on the hormone system.

M: Mutagenic substances may cause damage to the DNA, and are divided in heritable (Category 1A and 1B) or with unproven heritability (Category 2). The genotoxic damages may eventually cause cancer or effect reproduction negatively, and these effects may, in theory, occur after occasional exposure at low levels (Category 1A and 1B).

R: Substances that are toxic to reproduction impair fertility and cause toxic effect to embryo/foetus, with permanent effect.

In order for a substance to be classified as CMR, it is sufficient that one of the criteria is met.

Read more about the criteria for classification of CMR substances on the Swedish Chemicals Agency´s webpage. 

SVHC substances

The Candidate List of substances of very high concern (SVHC) is a list according to the European legislation, of about 200 especially hazardous substances that should be replaced or phased out. New substances are added to this list twice a year.

Note! Companies producing or distributing products containing more than 0.1% (by weight) of a SVHC substance must inform their customers, and need to register their goods in the SCIP database no later than January 5, 2021.

SVHC substances are substances where there is scientific support for serious effects on human health or the environment. They may be classified as showing at least one of the following properties: 

CMR: Carcinogenic, mutagenic (genotoxic) or toxic to reproduction. 
PBT: Persistent, bioaccumulating or toxic.
vPvB: Very persistent and very bioaccumulative substances.

or that they are substances where there is scientific evidence for other serious effects on human health or the environment, that raise equal levels of concern.

This last group contains for example endocrine-disruptive and very allergenic substances.

Endocrine disruptive substances – difficult to define

Endocrine disruptive substances have gained more attention during recent years, as the exposure of humans and environment as well as the knowledge about hormonal effects have increased.

The criteria to define a substance as endocrine disruptive are not as accepted as for CMR or PBT, but the effects are equally concerning. As in the case of CMR substances, the effects can be permanent and influence lives not yet born. Assessments to decide whether a substance is endocrine disruptive are done case by case, and efforts to develop standardized criteria and test methods are going on on an international level.

According to the current definition, the substance must be exogen (not produced within the body) and change the function of the hormone system, causing a negative effect for an organism, offspring or sub-population.

Increase in problems caused by endocrine disruptive substances  

Several health problems related to endocrine systems have increased significantly during the last decades. At the same time, the production of, and exposure to, endocrine disruptive substances has also increased. Problems believed to be associated with endocrine disruptive substances include decreased sperm production, congenital defects and hormone-related cancer. There are also indications of other links between endocrine disruptive substances and for example allergy, obesity or neuropsychiatric disorders.

These links are not unambiguous, due to the complex human life cycle and biology. There are other aspects of our lifestyle, besides increased exposure to chemicals, that have changed over the years, such as diet and exercise. There is also “noise” and other possible factors that may interfere. It is likely to believe that several factors act in combination, and that the exposure to endocrine disruptive substances is one important factor.

Environmental effects easier to measure 

The connection between endocrine disruptive substances and negative environmental effects have been observed more unambiguously. Many animals have less complex life cycles and less “noise”, and consequently the link between endocrine disruptive substances and negative effects becomes more easy to follow. It is also easier to study and verify the effect of the environment for a fish in the laboratory, than for a human. 

In nature the negative effect from endocrine disruptive substances has been documented, for example in thinner egg shells, behavior disorders in birds, skeletal abnormities, imposex (male genitalia in females) in marine molluscs, feminisation and masculinization of fish and disrupted reproductive rates in reptiles.

More information about endocrine disruptive substances at ECHAS website

These are the phase-out substances

• Carcinogenic, category 1A or 1B  
• Mutagenic, category 1A or 1B 
• Toxic to reproduction substances, category 1A or 1B 
• Persistent, bioaccumulative and toxic substances (PBT) 
• Very persistent and very bioaccumulative substances (vPvB) 
• Endocrine disruptors 
• Particularly hazardous metals (cadmium, mercury, lead, and their compounds) 
• Ozone-depleting substances