PRIO criteria for Phase-out substances and Priority risk-reduction substances
All substances in the PRIO database have been assigned a priority level based on the most hazardous inherent properties of each substance, at the phase-out substance level or at the priority risk reduction substance level. There are criteria for assessing whether a substance meets one or more properties for phase-out or priority risk reduction substances.
Substances that possess the most severe hazardous properties for human health and the environment are called phase-out substances in PRIO and are most important to prioritise for replacement or avoiding. Phase-out substances are substances that may be identified as a substance of very high concern (SVHC) and may gradually be subject to permit testing in the EU chemicals legislation REACH. Some of the phase-out substances are already banned or restricted in certain uses.
This generally applies to phase-out substances:
- It is a substance with particularly hazardous properties.
- The use of particularly hazardous substances shall as far as possible cease according to the quality objective A Non-Toxic Environment which is part of Swedish environmental quality objectives.
- In EU legislation REACH, such substances will be identified as SVHC substances and may gradually be subject to authorisation.
- Some of these substances are already banned in various uses.
- There are exceptions for substances within the group complex hydrocarbons and pesticides that are approved for use in the EU.
Properties of phase-out substances
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).
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 hormone-disrupting 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.
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.
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.
PBT/vPvB substances are persistent (poorly degradable), bioaccumulative (accumulate in living organisms) and toxic, alternatively very persistent and very bioaccumulative. If a substance or its transformation products is poorly degradable, it will remain in the environment for a long time.
The underlying assumption is that organic substances that are poorly degradable, can be taken up and enriched in living organisms and have toxic properties, always constitute a possible risk to human health and the environment. Persistent compounds, even though no toxicity have been shown in various tests, can with time lead to unpredictable adverse effects.
For substances that are both very poorly degradable and very bioaccumulative, it is even more difficult to assess the risks. The uncertainty in predicting future adverse effects is so great that even if it has not been proven in tests, some adverse effects is always assumed.
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 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 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.
Per- and polyfluoroalkyl substances (PFAS) 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. 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.
Priority risk-reduction substances
Substances with a little less hazardous properties compared to the phase-out substances, are called priority risk-reduction substance and have been assigned the lower level of prioritisation in PRIO.
Priority risk-reduction substances have hazardous properties. To assess the risk, you should review how the substance is used and understand and assess how large the exposure is. Based on your assessment, you may consider substitution. For some priority risk reduction substances, certain uses may already be banned.
For priority risk-reduction substances, the following generally applies:
- This is a substance with hazardous properties. Review the use and routes of exposure to the substance to assess the risk! Consider substitution!
- Some of these substances are already banned in various uses.
- According to the Swedish environmental quality objective A Non-Toxic Environment, the total exposure to chemical substances through all routes of exposure must not be harmful to humans or biological diversity.
Properties of Priority risk-reduction substances
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.
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.
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 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.
For many substances, available test data is not sufficient to make a complete assessment to determine whether they are PBT/ vPvB substances or not. In PRIO, potential PBT/vPvB substances are substances that fulfil the screening criteria in a “PBT assessment” within REACH, which is the first step in a PBT evaluation of a substance. Until sufficient information is available for a proper assessment, these substances should be treated as priority risk reduction substances. Caution and special measures should be taken to prevent these substances to spread to the environment.
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.
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.
Criteria for Phase-out substances and Priority risk reduction substances
There are criteria for assessing whether a substance meets one or more properties for phase-out or priority risk reduction substances. To determine whether a substance meets the criteria, a comparison is made against these based on available test data and/or other information on the substance.
Criteria/reference to determine intrinsic properties
Classification Carcinogenicity in Category 1A or 1B in accordance with CLP-Regulation
(Carc. 1A/1B, H350: May cause cancer.)
Classification Germ cell mutagenicity in Category 1A or 1B in accordance with CLP-Regulation
(Muta. 1A/1B, H340: May cause genetic defects.)
Toxic to reproduction
Classification Reproductive toxicity in Category 1A or 1B in accordance with CLP-Regulation
(Repr. 1A/1B, H360: May damage fertility or the unborn child.)
Fluorinated greenhouse gases (F-gases)
Substances listed in Annex I to the regulation on fluorinated greenhouse gases (EU 517/2014)
Endocrine disruptors are included in the definition of particularly hazardous substances in Sweden's environmental quality objectives A Non-Toxic Environment.
Classification Respiratory sensitisation Category 1 or Skin sensitisation in Category 1A in accordance with CLP-Regulation
(Resp. Sens 1, H334: may cause allergy or asthma symptoms or breathing difficulties if inhaled.)
(Skin Sens. 1A, H317: May cause an allergic skin reaction.)
Classification Hazardous to the ozone layer in Category 1 in accordance with CLP-Regulation
(Ozone 1, H420: Harms public health and the environment by destroying ozone in the upper atmosphere.)
PBT/vPvB – Persistent, bioaccumulative and toxic /very persistent and very bioaccumulative
Definition according to Annex XIII, REACH Regulation (EC) No 1907/2006
Particularly hazardous metals (Cd, Hg, Pb)
Cadmium, mercury and lead metals and their compounds are included in the definition of particularly hazardous substances in Sweden's environmental quality objectives A Non-Toxic Environment.
Particularly persistent substances (PFAS)
Per- and polyfluoroalkyl substances, PFAS have due to their extreme persistence, comparable hazardous properties to those of particularly hazardous substances defined in Sweden's environmental quality objectives A Non-Toxic Environment. PFAS should therefore from a precautionary perspective be treated similarly to other particularly hazardous substances and be phased out.
Definition of PFAS in PRIO: a substance which in their molecule contain one or more fragments consisting of a perfluorinated carbon chain having a chain length of at least two carbon atoms R1-(CF2)n-R2, were n>1 and R1 and R2 are optional atoms or groups as defined in KIFS 2018:4.
Criteria/reference to determine intrinsic properties
Classification Skin sensitisation in Category 1 or 1B in accordance with CLP-Regulation
(Skin Sens. 1/1B, H317: May cause an allergic skin reaction.)
Classification Carcinogenicity in Category 2 in accordance with CLP-Regulation
(Carc. 2, H351: Suspected of causing cancer.)
Environmentally hazardous long-term effects
Classification Hazardous to the aquatic environment
in Category Chronic 1 or 4 in accordance with CLP-Regulation
(Aquatic chronic 1, H410: Very toxic to aquatic life with long lasting effects.)
(Aquatic chronic 4, H413: May cause long lasting harmful effects to aquatic life.)
Classification Germ cell mutagenicity in Category 2 in accordance with CLP-Regulation
(Muta. 2, H341: Suspected of causing genetic defects.)
Very high acute toxicity
Classification Acute toxicity in Category 1 and 2 in accordance with CLP-Regulation
(Acute Tox. 1 / 2, H300: Fatal if swallowed.)
(Acute Tox. 1 / 2, H310: Fatal in contact with skin.)
(Acute Tox. 1 / 2, H330: Fatal if inhaled.)
Classification Specific target organ toxicity after single exposure in Category 1 in accordance with CLP-Regulation
(STOT SE 1, H370: Cause damage to organs.)
Potential PBT/vPvB – Persistent, bioaccumulative and toxic /very persistent and very bioaccumulative
The screening criteria for a PBT assessment according to REACH, Annex Xlll are met. See ECHA's guidance document for an PBT assessment.
Toxic to reproduction
Classification Reproductive toxicity in Category 2 or additional Category for effects on or through breast-feeding in accordance with CLP-Regulation
(Repr. 2, H361: Suspected of damaging fertility or the unborn child.)
(Lact. H362: May cause harm to breast-fed children.)
Specific target organ toxicity after repeated exposure
Classification Specific organ toxicity after repeated exposure in Category 1 in accordance with CLP-Regulation
(STOT RE 1, H372: Causes damage to organs through prolonged or repeated exposure.)