Origin of the criteria
The criteria (*1) of "PRIO substances" have been selected based on the Swedish Environmental Quality Objective for a Non-Toxic Environment (Government Bill 2000/01:65 (*2)), and in consideration of the EU chemicals legislation Reach (Registration, Evaluation and Authorisation of Chemicals).
Non-Toxic Environment, is concerned with the phasing-out of particularly hazardous substances according to a stated timetable and covers CMR substances (*3), persistent and bioaccumulating (PB (*4)) substances, very persistent and very bioaccumulating (vPvB (*5)) substances, mercury (Hg), cadmium (Cd) and lead (Pb). Endocrine-disrupting and ozone-depleting substances are also considered as phase-out substances since the aim of the legislation is to phase them out. In the longer term, the interim target will also cover strong allergenic and nerve-damaging substances, which are harmful to the immune system and other substances judged to entail an equivalent risk to human health.
Non-Toxic Environment, is also concerned with the continuous decrease of chemical substances that pose health and environmental risks and which are not considered as particularly hazardous substances but that nevertheless are hazardous. These include all other substances covered by CLP- classification and labelling and (KIFS 2005:7 (*6)). They also include all substances which, because of inadequate data, have not been classified as hazardous to health and the environment but which may be classified when more data on them become available. The hazardous substances also include those that exhibit hazardous properties other than those covered by the present-day classification system. Hazardous substances must be handled in such a way that they do not lead to exposure of humans and the environment that may entail risks or lead to concentrations increasing in relation to background levels.
In Reach, each area of use of particularly hazardous substances must be authorized. Particularly hazardous substances in Reach are: CMR substances (Category 1 and 2); persistent, bioaccumulating and toxic substances (PBT); very toxic and very bioaccumulating substances (vPvB); and other substances, for example endocrine disruptors, that are judged to have inherent properties of equivalent concern.
In drawing up the PRIO criteria, it has been considered to be of great significance that, as well as being in line with the targets in Non-Toxic Environment, these also reflects the criteria in the EU chemicals legislation, Reach. Account has also been taken of other criteria adopted in various international forums such as the Stockholm Convention on global restrictions on persistent organic pollutants (POPs (*7)) and the Geneva Convention (*8) on Long-Range Transboundary Air Pollution. Harmonisation of criteria is also significant in facilitating communication of the criteria with other countries. The criteria in the PRIO tool for PBT/vPvB substances therefore do not, for example, entirely agree with the criteria in interim target 3 of Non-Toxic Environment for PB/vPvB substances. The criteria of the PRIO tool for properties hazardous to health (CMR, Very high acute toxicity, Allergenic, Mutagenic Category 2, High chronic toxicity) agree with CLP classification criteria for these properties. The criteria of the PRIO tool are accounted for in more detail in the section The Criteria in detail.
*1 Criterion = Decisive characteristic; the one by which it can be decided that a particular condition is met.
*2 Government Bill 2000/01:65 Chemicals policy for a Non-Toxic Environment. Read more about the background in the report of the Chemicals Inquiry SOU 2000:53 Non-hazardous products – Proposals for implementation of new guidelines on chemicals policy and in the Annexes to this report.
*3 Substances that have been classified as Carcinogenic, Mutagenic or toxic to Reproduction in accordance with Regulation (EU) No 1272/2008 (CLP- classification and labelling) and the Swedish Chemicals Inspectorate regulations (KIFS 2005:7) on the classification and labelling of chemical products pursuant to the Council Directive 67/548/EEC. Observe that regulation KIFS 2005:7 will be replaced by CLP.
*4 P = Persistent, which means lasting and is used to describe the ability of a substance to resist degradation; B = Bioaccumulation, which means that the concentration of a particular substance in an organism increases as a result of being absorbed more quickly than it is broken down, disintegrates or is eliminated
*5 v = very.
*6 Swedish Chemicals Inspectorate regulations on classification and labelling of chemical products (KIFS1994:12) pursuant to the EC Council Directive 67/548/EEC. An evaluation of the hazard must be made for any substance or preparation manufactured within or imported into the EU and placed on the EU market and results in classification of the substance/preparation as dangerous for one or several endpoints.
*7 POP - Persistent Organic Pollutants.
*8 Geneva Convention – Convention on Long-Range Transboundary Air Pollution (CLRTAP).