PRIO criteria for phase-out substances and priority risk-reduction substances
Content:
All substances in the PRIO database have been assigned a priority level based on their most hazardous inherent properties, 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. The criteria refer to the inherent hazard properties of individual substances.
Phase-out substances
Substances that possess the most severe hazardous properties for human health and the environment are called phase-out substances in PRIO and should be prioritised for substitution. Phase-out substances are substances that may be identified as substances of very high concern (SVHC) and may therefore gradually be subject to authorisation the EU chemicals legislation REACH. Some of the phase-out substances are already banned or restricted in certain uses.
The following 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 the EU legislation REACH, such substances may be identified as SVHC and gradually be subject to authorisation.
- Some of these substances are already banned in various uses.
- Pesticides are exempted if they are approved (or under approval) as active substances for use in other legislation within the EU (EU Biocidal Products Regulation No. 528/2012 or EU Plant Protection Products Regulation No. 1107/2009)
- Substances within the group complex hydrocarbons are exempted if the concentration of e.g. benzene or polycyclic aromatic hydrocarbons (PAH) falls below the limit value for the substances to be classified as CMR category 1 according to the CLP Regulation (EU) No 1272/2008. Read more about properties of the phase-out substances
Criteria for phase-out substances
To determine whether a substance meets the criteria, a comparison is made against these based on available information that is relevant to determine whether the substance poses an environmental or health hazard. The information can, for example, consist of data from epidemiological studies, animal tests (in vivo), non-animal tests (in vitro/in chemico), computer modelling (QSAR) (in silico) or come from reading information from similar subjects (read-across).
Property | Criteria |
|---|---|
Carcinogenic | Substances that fulfil the criteria to be classified as carcinogens in Category 1A or 1B according to the CLP Regulation (EC) No 1272/2008 (Carc. 1A or 1B, H350: May cause cancer) |
Mutagenic | Substances that fulfil the criteria to be classified as germ cell mutagens in Category 1A or 1B in accordance with CLP Regulation (EC) No 1272/2008 (Muta. 1A or 1B, H340: May cause genetic defects) |
Toxic to reproduction | Substances that fulfil the criteria to be classified as reproductive toxicants in Category 1A or 1B in accordance with CLP Regulation (EC) No 1272/2008 (Repr. 1A or 1B, H360: May damage fertility or the unborn child) |
Fluorinated greenhouse gases (F-gases) | The Kigali Amendment on hydrofluorocarbons (HFC) to the international convention Montreal Protocol |
Endocrine disrupting | Substances that fulfil the criteria to be classified as endocrine disruptors for human health or the environment in Category 1 according to the CLP Regulation (EC) No 1272/2008, or (ED HH 1, EUH380: May cause endocrine disruption in humans) (ED ENV 1, EUH430: May cause endocrine disruption in the environment) Substances identified as endocrine disruptors for human health or the environment within any of the following EU regulations; REACH Regulation (EC) No 1907/2006, Biocidal Products Regulation (EC) No 528/2012 or Plant Protection Products Regulation (EC) No 1107/2009 |
Strongly allergenic | Substances that fulfil the criteria to be classified as respiratory sensitisers Category 1, 1A or 1B, or skin sensitisers in Category 1A in accordance with CLP Regulation (EC) No 1272/2008 (Resp. Sens 1A or 1B, H334: may cause allergy or asthma symptoms or breathing difficulties if inhaled) (Skin Sens. 1A, H317: May cause an allergic skin reaction) |
Ozone depleting | Substances that fulfil the criteria to be classified as hazardous to the ozone layer in Category 1 in accordance with CLP Regulation (EC) No 1272/2008 (Ozone 1, H420: Harms public health and the environment by destroying ozone in the upper atmosphere) |
PBT/vPvB | Substances that fulfil the criteria to be classified as persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with CLP-Regulation CLP Regulation (EC) No 1272/2008, or (PBT, EUH440: Accumulates in the environment and living organisms including in humans) (vPvB, EUH441: Strongly accumulates in the environment and living organisms including in humans) Substances that fulfil the criteria in Annex Xlll, REACH Regulation (EC) nr 1907/2006, or criteria in Annex D, Stockholm Convention |
PMT/vPvM | Substances that fulfil the criteria to be classified as persistent, mobile and toxic or very persistent and very mobile according to the CLP Regulation (EC) No 1272/2008 (PMT, EUH450: Can cause long-lasting and diffuse contamination of water resources) (vPvM, EUH451: Can cause very long-lasting and diffuse contamination of water resources) |
Particularly hazardous metals (Cd, Hg, Pb) | Cadmium, mercury, lead and their compounds are included in the definition of particularly hazardous substances in Sweden's environmental quality objectives A Non-Toxic Environment. |
PFAS, Particularly persistent substances | PFAS (Per- and polyfluoroalkyl substances) 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. PFASs are defined as fluorinated substances that contain at least one fully fluorinated methyl or methylene carbon atom (without any H/Cl/Br/I atom attached to it), i.e., with a few noted exceptions, any chemical with at least a perfluorinated methyl group (–CF3) or a perfluorinated methylene group (–CF2–). (OECD, 2021) |
Priority risk-reduction substances
Substances with a little less hazardous properties for human health and the environment compared to the phase-out substances, or for those substances where the data is not sufficient to assess it as a phase-out substance, 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.
Read more about properties of the priority risk-reduction substances
Criteria for priority risk-reduction substances
To determine whether a substance meets the criteria, a comparison is made against these based on available information that is relevant to determine whether the substance poses an environmental or health hazard. The information can, for example, consist of data from epidemiological studies, animal tests (in vivo), non-animal tests (in vitro/in chemico), computer modelling (QSAR) (in silico) or come from reading information from similar subjects (read-across).
Property | Criteria |
|---|---|
Allergenic | Substances that fulfil the criteria to be classified as skin sensitiser Category 1 or 1B in accordance with CLP Regulation (EC) No 1272/2008 (Skin Sens. 1 or 1B, H317: May cause an allergic skin reaction) |
Carcinogenic | Substances that fulfil the criteria to be classified as carcinogens in Category 2 in accordance with CLP Regulation (EC) No 1272/2008 (Carc. 2, H351: Suspected of causing cancer) |
Environmentally hazardous long-term effects | Substances that fulfil the criteria to be classified as hazardous to the aquatic environment in Category Chronic 1 or 4 in accordance with CLP Regulation (EC) No 1272/2008 (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) |
Mutagenic | Substances that fulfil the criteria to be classified as germ cell mutagens in Category 2 in accordance with CLP Regulation (EC) No 1272/2008 (Muta. 2, H341: Suspected of causing genetic defects) |
Very high acute toxicity | Substances that fulfil the criteria to be classified as acute toxicants in Category 1 and 2 in accordance with CLP-Regulation (EC) No 1272/2008, or (Acute Tox. 1 or 2, H300: Fatal if swallowed) (Acute Tox. 1 or 2, H310: Fatal in contact with skin) (Acute Tox. 1 or 2, H330: Fatal if inhaled) Substances that fulfil the criteria to be classified as specific target organ toxicant after single exposure in Category 1 in accordance with CLP Regulation (EC) No 1272/2008 (STOT SE 1, H370: Cause damage to organs) |
Potential endocrine disrupting | Substances that fulfil the criteria to be classified as endocrine disruptors for human health or the environment in Category 2 in accordance with CLP Regulation (EC) No 1272/2008, or (ED HH 2, EUH381: Suspected of causing endocrine disruption in humans) (ED ENV 2, EUH431: Suspected of causing endocrine disruption in the environment) Substances that are under evaluation for endocrine disrupting properties in any regulatory expert group. |
Potential PBT/vPvB | Substances that fulfil the screening criteria for a PBT assessment according to REACH Regulation (EC) No 1907/2006, or are under assessment for PBT/vPvB in any regulatory expert group. |
Toxic to reproduction | Substances that fulfil the criteria to be classified as reproductive toxicants in Category 2 or Additional category for effects on or via lactation in accordance with CLP Regulation (EC) No 1272/2008 (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 | Substances that fulfil the criteria to be classified as specific target organ toxicant after repeated exposure in Category 1 in accordance with CLP Regulation (EC) No 1272/2008 (STOT RE 1, H372: Causes damage to organs through prolonged or repeated exposure) |
Version history PRIO criteria
With the relaunch of PRIO in October 2020, the tool got a new look and also changed its name to PRIO - a tool for substitution. In connection with the new launch, the tool was expanded with more criteria for so-called phase-out substances and priority risk-reduction substances. Subsequent criteria updates that have been made are based on the criteria version released in conjunction with the October 2020 relaunch.
Update February 2024
Two new criteria are introduced in PRIO
- PMT/vPvM - substances that are persistent, mobile and toxic or very persistent and very mobile were added as a criterion at the priority level phase-out substance. The criterion includes substances that meet the criteria to be classified as PMT/vPvM according to the CLP Regulation (EC) No. 1272/2008.
- Potential endocrine disrupting – substances that are suspected endocrine disruptors for human health or the environment were added as a criterion at the priority level priority risk-reduction substance. The criterion includes substances that meet the criteria to be classified as as endocrine disruptors for human health or the environment in Category 2 in accordance with CLP Regulation (EC) No 1272/2008, or substances that are under evaluation for endocrine disrupting properties in any regulatory expert group.
Changes to three existing criteria
- PBT/vPvB – substances that are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative is a criterion at the priority level phase-out substance. The criterion has been updated to also include substances that meet the criteria to be classified as PBT/vPvB according to the CLP Regulation (EC) No. 1272/2008.
- Potential PBT/vPvB - substances that are suspected to be persistent, bioaccumulative and toxic or very persistent and very bioaccumulative is a criterion at the priority level priority risk-reduction substance. Only the criterion description has been updated, the criterion is otherwise unchanged.
- Endocrine disrupting – substances that are endocrine disruptors for human health or the environment is a criterion at the priority level phase-out substance. The criterion has been updated to also include substances that meet the criteria to be classified as endocrine disruptors for human health or the environment in Category 1 according to the CLP Regulation (EC) No. 1272/2008, or substances identified as endocrine disruptors for human health or the environment within any of the following EU regulations; REACH Regulation (EC) No. 1907/2006, Biocidal Products Regulation (EC) No. 528/2012 or Plant Protection Products Regulation (EC) No. 1107/2009.
In addition to the criteria changes, the Swedish Chemicals Agency has also improved the written texts describing the criteria with the aim to clarify that it is the substances that must meet the criteria and not products.
Update December 2024
Updated criterion
- PFAS, Particularly persistent substances
New definition of PFAS is applied in PRIO. The definition was changes from the one stated in the Agency Regulations (KIFS 2018:4) to the OECD's definition from 2021. The update involves a broader definition of PFAS and therefore includes many more PFAS substances.
Criteria at the new launch, October 2020
Phase-out substance
- Carcinogenic (Carc. 1A or 1B)
- Mutagenic (Muta. 1A or 1B)
- Toxic to reproduction (Repr. 1A or 1B)
- Fluorinated greenhouse gases (F-gases)
- Endocrine disrupting
- Strongly allergenic (Resp. Sens. 1 or Skin Sens. 1A)
- Ozone depleting (Ozone 1)
- PBT/vPvB (Persistent, Bioaccumulative and Toxic or very Persistent and very Bioaccumulative)
- Particularly hazardous metals (Cd, Hg, Pb)
- PFAS, Particularly persistent substances (PFAS definition according to KIFS 2018:4, R1-(CF2)n-R2, were n>1 and R1 and R2 are optional atoms or groups)
Priority risk-reduction substance
- Allergenic (Skin Sens. 1 or 1B)
- Carcinogenic (Carc. 2)
- Mutagenic (Muta. 2)
- Toxic to reproduction (Repr. 2 or Lact.)
- Environmentally hazardous long-term effects (Aqatic chronic 1 or 4)
- Very high acute toxicity (Acute Tox. 1, 2 or STOT SE 1)
- Potential PBT/vPvB (Potentially Persistent, Bioaccumulative and Toxic or very Persistent and very Bioaccumulative)
- Specific target organ toxicity after repeated exposure (STOT RE 1)
