What substances are in PRIO?

CMR substances are known or presumed to be carcinogenic, germ cell mutagenic, or toxic to reproduction. The properties of CMRs are so adverse that humans should not be exposed to these substances. It is assumed that even a single exposure of a very small amount of a CMR substance may cause permanent damage.

A carcinogenic substance is a substance that may cause damage in cells and tissues, which in the long term may turn into cancer. A germ cell mutagenic substance is a substance that may cause heritable mutations, i.e. changes in the genome, in germ cells. A substance that is toxic to reproduction may damage the sexual function, the ability to have children and/or the development of the embryo, foetus or child.

Fluorinated greenhouse gases (F-gases) are a group of gases most often used to replace substances that can deplete the ozone layer. They do not destroy the ozone layer but are very powerful greenhouse gases and, being thousands of times more powerful than carbon dioxide, they contribute to global warming. The fluorinated greenhouse gases include fluorocarbons (HFCs), perfluorocarbons (PFCs) and sulfur hexafluoride (SF6).

Read more about the substance group Chlorofluorocarbons (CFCs) and Hydrogen fluorocarbons (HFCs).

Endocrine disruptors are substances that are foreign to the body and may disrupt the body’s own hormonal system. Many important processes in the body are regulated by hormones acting at very low levels in the body. These substances can, for example, contribute to impact on metabolism and the ability to have children, or contribute to the development of hormone-dependent cancers such as breast cancer.

The most critical stage for effects is the fetal stage. If a fetus is exposed to a endocrine disruptor substance, it can, for example, have effects on brain development or cause an increased risk of diseases in adulthood. In adults, the mechanism for regulating hormone levels in the body are more developed compared to fetuses and young children. This increases the risk for an endocrine disruptor to have irreversible effects on these more sensitive groups. During development, hormones control how cells mature and how they migrate to the right location. If this process is disturbed, it can cause permanent disturbances.

In the same way, endocrine disrupting substances can have harmful effects in the environment. They can affect animal reproduction in various ways, for example by reducing fertility, and have harmful effects on the animals´ development, immune system, metabolism or cause behavioral disorders. All of these disturbances can have a major impact on the survival of populations. As for humans, the endocrine disrupting effect may not manifest itself until long after exposure. For example, if the animal is exposed in the egg or fetal stage, the effect may only be detected when the animal itself has its offspring, or in even later generations.

Sensitisers are substances that can activate the immune system and cause sensitisation. Once individuals are sensitised, they can have severe allergic reactions to further exposure, even if the doses are very low. Respiratory sensitiser means a substance that will lead to hypersensitivity of the airways following inhalation of the substance. Skin sensitiser means a substance that will lead to an allergic response following skin contact.

Respiratory sensitisers may induce asthma. Asthma is a severe adverse health effect and individuals should not be exposed to such substances. Very low doses of skin sensitising substances in Category 1A can cause severe allergic skin reactions. Exposure to these substances should therefore be avoided.

Note that mixtures containing one or more respiratory sensitisers, e.g., allergenic enzymes in cleaning agents, are not necessarily classified as allergenic. The generic concentration limit according to the CLP regulation for classification of mixtures in solution or granular form containing respiratory sensitisers is 1%, which is higher than for other hazard properties of phase-out substances in PRIO (normally 0.1% alternatively 0.3%).

The classification H420 according to CLP Regulation means that the substance is "Damaging to public health and the environment by destroying ozone in the upper part of the atmosphere".

In the stratosphere, sunlight constantly converts some of the oxygen molecules in the air into ozone. This ozone layer filters out harmful UV radiation from the sun. UV radiation can cause very hazardous effects to public health and the environment, as well as damage to technical material. The thinning of the ozone layer comes from emissions of ozone depleting substances such as CFCs (chlorofluorocarbons), HCFCs (chlorofluorocarbons), halons, chlorinated solvents, methyl bromide and similar substances. It is the chlorine or bromine content of these substances that depletes ozone in the stratosphere. The use of ozone depleting substances must be phased out in accordance with the Swedish environmental quality objective A Protective Ozone Layer. External link, opens in new window.

PBT/vPvB substances are persistent, bioaccumulative (accumulate in living organisms) and toxic, alternatively very persistent and very bioaccumulative. If a substance or its transformation- or degradation products is persistent, it will remain in the environment for a long time.

The underlying assumption is that organic substances that are persistent, bioaccumulative and have toxic properties, always constitute a possible risk to human health and the environment. Persistent substances can over time lead to unpredictable adverse effects.

For substances that are both very persistent and very bioaccumulative the uncertainty in predicting future adverse effects is high and even if it has not been proven in tests, some adverse effects are always assumed.

PMT/vPvM substances are persistent mobile and toxic, alternatively very persistent and very mobile. A substance is persistent if it or its transformation- or degradation products do not break down to any significant extent in the environment, leading to their remaining in the environment for a long time. A persistent substance, which is also mobile, will be transported through the ground and can accumulate in water-rich environments and thereby constitute a risk for contaminating groundwater or other sources of drinking water. In addition, these substances are difficult to remove in waste water treatment plants.

The underlying assumption is that organic substances that are persistent, mobile and have toxic properties, always constitute a possible risk to human health and the environment. Persistent substances can over time lead to unpredictable adverse effects.

For substances that are both very persistent and very mobile, the uncertainty in predicting future adverse effects is high and even if it has not been proven in tests, some adverse effects are always assumed.

Cadmium

Cadmium remains in the body for a long time and accumulates particularly in the kidneys. When exposed for a longer period of time, the function of the kidney is damaged. Cadmium can also cause cancer, gene mutations and effects on bone density. The adverse effects arise already at low exposure levels. Cadmium is also hazardous to the environment with both acute and chronic effects.

Mercury

Mercury and its compounds (principally methylmercury) have adverse effects particularly on the nervous system and its development. They also has adverse effects on the cardiovascular system, immune system, reproductive system and kidneys. Disturbance to the development of the nervous system and toxicity to the central nervous system are the most sensitive and best documented effects. Mercury is transferred to the foetus, crosses the blood-brain barrier and probably inhibits brain development even at low concentrations. Children exposed to low concentrations of methylmercury for a long time may exhibit learning difficulties and impaired intellectual capacity.

Mercury is transformed to methylmercury by natural processes in the environment and is bioaccumulated in the food chain.

Lead

Lead and its compounds have adverse effects particularly on the nervous system and can give rise to impaired cognitive development and intellectual performance, foetuses and small children being particularly sensitive. Lead can be transferred from the placenta to the foetus and to breastfeeding babies through breast milk and can affect the development of the brain at low exposure levels. Lead can also affect the ability to have children. Other effects are high blood pressure and increased incidence of cardiovascular diseases in adults. International Agency for Research on Cancer (IARC) has classified lead as presumed carcinogenic.

PFAS (Per- and polyfluoroalkyl substances) are a group of organic substances that are extremely persistent (poorly degradable), by themselves or as degradation products. This means that they will remain in the environment for a very long time. All PFAS found in the environment are man-made since PFAS are not naturally occurrent in the environment. Some of them are bioaccumulative, i.e. they enrich in living organisms. Some of them are mobile, which means they can be widely distributed throughout the environment. For a few PFASs, such as PFOS and PFOA, there is evidence that they are harmful to human health but for most PFAS, there is still a lack of knowledge when it comes to their effects on health. However, there is reason to suspect that all PFASs may be harmful to human health.

All PFAS substances in PRIO fulfils the OECD PFAS definition (2021).

Learn more about PFAS.

Skin sensitising substances can activate the immune system and cause sensitisation after repetitive skin contact. Once individuals are sensitised, they can have allergic skin reactions to further exposure. For substances in category 1 or 1B, higher doses are required for an allergic skin reaction to occur, or the allergic reaction is not as severe when compared to skin sensitising substances in category 1A.

Carcinogenic substances in category 2 may cause cancer, however, the evidence for these effects is not as strong as for carcinogenic substances in category 1A and 1B. Substances that are carcinogenic in category 2 are considered suspected human carcinogens.

Mutagenic substances in category 2 may cause genetic defects in human germ cells, however, the evidence for these effects is not as strong as for germ cell mutagens in category 1A and 1B. Mutagenic substances in category 2 are therefore considered having the potential to induce heritable mutations in the genetic material of humans. Mutagenic properties may lead to heritable mutations or damage that in the long term may lead to cancer or defects on reproduction. It is assumed that even a single exposure of a very small amount of a mutagenic substance may cause damage. The evidence for mutagenic substances in category 2 is normally based on mutagenic effects in somatic cells (not germ cells) of mammals in experimental studies.

Substances that are toxic to reproduction in category 2 can cause adverse effects on sexual function and fertility, and on development of the embryo, foetus or child in humans. However, the evidence for these effects is not as strong as in category 1A and 1B. Substances that are toxic to reproduction in category 2 are considered as suspected human reproductive toxicants.

This refers to substances classified as Hazardous to the aquatic environment, category chronic 1 (H410) or hazardous to the aquatic environment, category chronic 4 (H413) according to the CLP Regulation. The reason for choosing these two classification criteria is the ability of these substances to cause long-term negative effects. This approach is in accordance with the intentions of “A Non-Toxic Environment” to reduce exposure of substances with long lasting effects.

A substance classified as H410 is very toxic to aquatic life with long lasting effects.

Classification with hazard statement code H413 is a kind of safety net classification where, in absence of chronic toxicity data, the hazard for long term effects is suspected to be similar as for substances classified with H410. Hazard code H413 is used for substances which may bioaccumulate (BCF≥500 or log Kow≥4), are not rapidly degradable, have low water solubility (<1mg/l) but no acute toxicity is expressed in toxicity tests performed at the solubility limit. Another example of when classification with the hazard statement H413 is relevant is for toxic metals for which there is no information available on transformation/dissolution.

Substances with hazard statement code H411 and H412 (according to CLP-Regulation), do not meet this PRIO criterion as these substances have a known lower chronic toxicity than H410.

Substances that produce high acute toxicity are substances that at single low exposure concentrations can cause mortality and/or specific, target organ toxicity, both reversible and irreversible, immediate and/or delayed. Specific target organ toxicity can occur by any route that is relevant for humans, i.e. principally oral, dermal or inhalation. The adverse effects include toxicologically significant changes which have affected the function or morphology of a tissue, organ or organ system, sometimes fatal.

Potential PBT/vPvB substances are suspected of having persistent, bioaccumulative (accumulate in living organisms) and toxic properties, alternatively very persistent and very bioaccumulative properties. See description of properties for PBT/vPvB substances. For potential PBT/vPvB substances applies that they meet the screening criteria for a PBT assessment within REACH Regulation External link..

Substances that have been assessed to meet the criteria for PBT/vPvB will change priority level in PRIO, from being considered a priority risk-reduction substance to a phase-out substance. The operator should consider whether a potential PBT/ vPvB substance should be dealt with as a phase-out substance.

Potentially endocrine disrupting substances are substances that are suspected to be endocrine disrupting. Endocrine disrupting substances are foreign to the body and can disrupt the normal function of the body's hormone system. See description of properties for endocrine disrupting substances.

Substances classified in Category 2 according to the CLP regulation are suspected of causing endocrine disruption for human health or the environment. Substances that are under assessment for endocrine disruption are considered as potential endocrine disruptors in PRIO.

Substances that have been concluded as an endocrine disruptor will change priority level in PRIO, from being considered a priority risk reduction substance to a phase-out substance. The operator should consider whether a potential endocrine disruptor should be handled as a phase-out substance.

Substances that cause effects on or via lactation are allocated to a separate subcategory. The property hazardous to breastfed babies should be indicated when substances are absorbed by women and have been shown to interfere with lactation, or which may be present in breast milk in amounts sufficient to cause concern for the health of a breastfed child.

Substances that produce target organ toxicity after repeated or long-term exposure are substances that at low exposure concentrations can cause specific, target organ toxicity, both reversible and irreversible, immediate and/or delayed. Specific target organ toxicity can occur by any route that is relevant for humans, i.e. principally oral, dermal or inhalation. The adverse effects include toxicologically significant changes which have affected the function or morphology of a tissue, organ or organ system, sometimes fatal.

The list of hazardous substances for which harmonised classifications and labels are established at Community level is given in Annex VI to CLP. Certain substances in PRIO with reference to the CLP Regulation are included in unspecified group entries in Annex VI to the Regulation, where the group affiliation is based on the assessment of the Swedish Chemicals Agency's.

 Go to Echas database for classification and labelling register External link.

Substances with reference ED assessments, ECHA are suspected hormone disrupting substances which do not have a harmonised classification for endocrine disruption according to CLP or concluded to be an endocrine disruptor in other EU legislation, for example REACH.

Potential hormone disrupting substances with reference ED assessments, ECHA are under evaluation for endocrine disrupting properties by ECHAs ED expert group. The Swedish Chemicals Agency has not done any further work to identify potential ED substances.

On the website Endocrine Disruptor Lists, there are lists with substances that are endocrine disruptors or suspected endocrine disruptors. In PRIO, substances from List 1 are included that have been identified as endocrine disruptors under the Plant Protection Products Regulation, the Biocidal Products Regulation or Reach. The website is an initiative by the Danish EPA in cooperation with other authorities within the EU, including the Swedish Chemicals Agency. The number of substances in PRIO with reference to the Endocrine Disruptor Lists exceeds the number of entries on List 1 on the website as several substances in PRIO have been identified from group entries.

Go to the Endocrine Disruptor Lists External link.

A global agreement to protect the ozone layer is governed by a convention under the United Nations Environment Program, UNEP. The Montreal Protocol, signed in 1987, contains binding agreements on the reduction of the use and production of various substances or groups of substances that deplete the ozone layer. The protocol is revised regularly. Following the 1999 amendment, the Montreal Protocol includes a timetable for the phasing out of eight ozone-depleting substances or groups of substances. The phasing out of substances that deplete the ozone layer is regulated in the EU via Regulation (EC) No 1005/2009 of the European Parliament and of the Council on substances that deplete the ozone layer. After the 2017 addition, the so-called Kigali Addition on Fluorocarbons (HFCs), the Montreal Protocol also includes a timetable for phasing out HFCs, which are potent greenhouse gases and contribute to global warming. The use of fluorinated greenhouse gases is regulated within the EU via the F-gas regulation, Regulation (EU) No 517/2014.

Read more about the Montreal protocol External link.

Substances with reference PBT/vPvB assessments, ECHA are suspected PBT/vPvB substances which do not have a harmonised classification for PBT/vPvB according to CLP or concluded to be a PBT/vPvB substance in REACH or the Stockholm Convention.

Potential PBT/vPvB are substances that are either 1) under evaluation for PBT/vPvB properties by ECHAs PBT expert group, or 2) have been evaluated by the former expert committee under the previous chemicals legislation (EC/793/93) and where suspicion of PBT/vPvB remains, or 3) by REACH registrants assessed as PBT/vPvB. The Swedish Chemicals Agency has not done any further work to identify potential PBT/vPvB substances.

The SIN List is the International Chemicals Secretariat's (ChemSec) list of substances which, based on their assessment, meet the criteria for being substances of very high concern (SVHC) according to the REACH regulation. The SIN List includes a selection of PFAS substances with registered uses (production or import) in the EU and/or the USA. The reference PFAS, ChemSec SIN List refers to PFAS substances on the SIN List.

Go to ChemSec SIN List External link.

In 2018, the OECD produced a list of more than 4700 PFAS (perfluoroalkyl substances) based on a comprehensive analysis of available information. The list is an update of an earlier publication from 2007. The work has been carried out under the OECD / UN Global PFC Group on the Environment in support of the strategic strategy for International Chemicals Management (SAICM) and a transition to safer alternatives to PFAS.

Go to the PFAS List on the website of OECD External link.

The US Environmental Protection Agency (US EPA) has established a comprehensive database of PFAS substances (PFAS Master List). The reference PFAS, US EPA Master List in PRIO refers to a selection of PFAS substances from this database. The selection was based on the following criteria: 1) substances that fulfil the OECD PFAS definition (2021); 2) substances that have CAS numbers; 3) substances that are not isotopically labelled.

Go to PFAS Master List on the US EPA website External link.

The Authorisation List includes substances of very high concern that have been identified within the REACH Regulation and which require authorisation in order to be used or placed on the market. Substances that require authorisation are listed in Annex XIV to the REACH Regulation. The list contains more than 50 substances or substance groups. The number of substances in PRIO with reference to the Authorisation List exceeds the number of entries in the official list as several substances in PRIO have been identified from the Authorisation List's group entries.

Go to the Authorisation List on ECHA website. External link.

The Candidate List includes substances that have been identified as substances of very high concern (SVHC) under the REACH Regulation. The list contains more than 200 substances or substance groups. The number of substances in PRIO with reference to the Candidate List exceeds the number of entries in the official list as several substances in PRIO have been identified from the Candidate List's group entries.

Go to the Candidate List on ECHA website External link.

The Swedish Marine and Water Authority's regulations (HVMFS) 2019: 25 on classification and environmental quality standards regarding surface water (lakes and watercourses) list in Annex 2 River Basin Specific Pollutant or groups of pollutants and their maximum permitted concentration. The regulation states that a classification of ecological status must be done for these pollutants if they are released or added in a significant amount into surface water. PRIO contains only those substances from the regulation that meet PRIO's criteria. For listed groups of substances in the regulation, only the group members who have been specified with CAS numbers receive the reference River Basin Specific Pollutant, HVMFS (2019:25) in PRIO.

Go to HVMFS 2019:25 (available only in Swedish) External link.

Stockholm Convention on Persistent Organic Pollutants (2001) is a global treaty with the aim of protecting humans and the environment from POPs, i.e. substances that can be transported over long geographical distances before being degraded. Within the EU, these substances are regulated in the POPs Regulation, Regulation (EU) 2019/1021.

Go to the website of the Stockholm convention External link.

The Water Framework Directive (WFD) 2000/60/EC was established by the European Parliament and of the Council and is a framework for water policy within the Community. The directive aims at protecting and improve water quality in the EU and is a common strategy against water pollution.

The Water Framework Directive was last updated by Directive 2013/39/EU of the European Parliament and of the Council, which includes environmental quality standards specifying the maximum permitted concentration for 45 priority substances or groups of substances in water, sediment or biota.

The WFD has been incorporated into Swedish legislation through the Swedish Water Quality Management Ordinance (2004:660) and associated regulations. Thus, the environmental quality standards in the ordinance are legally binding and cover surface waters (lakes and watercourses), groundwater and coastal waters. For certain substances there are also national environmental quality standards for additional matrices (Appendix 6, HVMFS 2019:25). PRIO contains only those priority substances from the WFD that meet PRIO's criteria. For listed groups of priority substances in the WTD, only those group members who have been identified with CAS numbers receive the reference Priority substances, Water Framework Directive (2000/60/EC) in PRIO.

Read more about the EU Water Framework Directive. External link.