What substances are in PRIO?
The database PRIO consists of chemical substances with properties that are hazardous to health and the environment. Regarding some PRIO substances some uses may already be limited or banned, but many substances are still allowed to use. The primary aim of PRIO is to help you to find hazardous substances that are not yet banned within the EU, substances that we know to be present in chemical products and articles. However, the database is not a complete list of all hazardous or banned substances that can be present in products on the market.
What substances are included in PRIO?
The substances thar are included in the database PRIO have been thoroughly assessed and the hazardous properties are verified either through harmonised classification or by an expert committee. Most of the substances have a classification that is harmonised in the EU. This means that the substances have undergone an EU process for assessing the environmental and health properties of the substances. PRIO includes substances classified as
- cancerogenic, mutagenic or toxic to reproduction (CMR)
- environmentally hazardous long-term effects
- very high acute toxicity
- ozone depleting
- specific target organ toxicity after repeated exposure
The criteria in PRIO also include particularly hazardous substances defined in the Swedish environmental objective A Non-Toxic Environment. Particularly hazardous substances include
- cancerogenic, mutagenic or toxic to reproduction (CMR), Category 1A and 1
- persistent, bioaccumulative and toxic (PBT) /very persistent and very bioaccumulative (vPvB)
- particularly hazardous metals such as mercury (Hg), cadmium (Cd), lead (Pb) and their compounds
- endocrine disruptive (There are, however, no established criteria for these properties. It must be assessed from case to case.)
- per- and polyfluoroalkyl substances (PFAS)
A large group of substances in the database PRIO consist of per- and polyfluoroalkyl substances, PFAS or "eternal chemicals" as they also are called because the substances are extremely persistent (poorly degradable) or transform into extremely persistent substances and therefore do not degrade in nature. The severity of PFAS is comparable to that of particularly hazardous substances. As a precautionary measure, these substances should be handled as particularly hazardous substances.
References to the substances in PRIO
The references to the substances in the database PRIO indicate where the information on its properties is obtained.
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.
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.
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.
Substances with reference PBT/vPvB assessment, ECHA are substances where there is suspicion of PBT/vPvB or where the substance has been concluded to meet the criteria for PBT/vPvB but has not yet been added to the Candidate List or included in the Stockholm Convention.
Potential PBT/vPvB are substances that are either 1) concluded to meet the PBT or vPvB criteria in REACH by ECHA's PBT expert group or are under evaluated by the group or 2) have been evaluated by the expert committee that existed under the previous chemicals legislation (EC / 793/93) and where suspicion of PBT/vPvB remains or 3) by registrants within REACH assessed as PBT/vPvB, i.e. the substances meet the screening criteria for a PBT assessment within REACH.
For more information, see the criteria for potential PBT/vPvB substances. (A few substances in PRIO with reference PBT/vPvB assessment, ECHA are assessed as PMT (persistent, mobile and toxic) by ECHA's PBT expert group.)
The Swedish Chemicals Agency has not done any further work to identify potential PBT/vPvB substances in addition to what is described above.
In 2018, the OECD produced a list of more than 4700 perfluoroalkyl substances, PFAS, based on a comprehensive analysis of available information. In total, more than 4,500 substances from the OECD list that meet the criteria of PFAS as described in KIFS 2018: 4, have been included in PRIO. 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.
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.
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.
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.
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.
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.