Background – PRIO
PRIO is a tool developed by the Swedish Chemicals Agency to help companies and other actors to detect and substitute hazardous substances in products and articles that they handle. The criteria for the PRIO substances are based on the environmental quality objective A Non-Toxic Environment set by the Swedish government and on the EU chemicals legislation Reach.
A Non-Toxic Environment
According to the clarification of the Swedish environmental objective A Non-Toxic Environment the use of particularly hazardous substances is, as far as possible, to be ceased. The definition of particularly hazardous substances are substances that are cancerogenic, mutagenic and toxic to reproduction (CMR), persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), and particularly hazardous metals (mercury, cadmium, lead and their compounds). Particularly hazardous substances also include endocrine disruptors and strongly allergenic substances. An addition to the particularly hazardous substances are Per- and polyfluoroalkyl substances, PFAS which have a comparable hazardous properties to those of particularly hazardous substances due to their extreme persistence and should be treated as such for precautionary reasons.
A Non-Toxic Environment is about a continuous reduction of health and environmental risks of chemicals that are not defined as particularly hazardous substances but still are hazardous. These substances include all other substances included in CLP Classification and labelling EC No 1272/2008. Also included are substances that due to lacking information have not been classified as being hazardous to health and the environment at present but can be classified as such after receiving more information of the substances.
The REACH Regulation
The REACH Regulation EC No 1907/2006 stipulates that authorisation is required for handling hazardous substances. Substances of very high concern (SVHC) in Reach are substances with inherent properties such as being cancerogenic, mutagenic, toxic to reproduction (CMR) in category 1A and 1B; persistent, bioaccumulative and toxic (PBT); very persistent and very bioaccumulative (vPvB); and other substances were an equal level of concern (to those of SVHC) have been argued, for instance endocrine disruptors.
Other international conventions and agreements
We have also taken into consideration other criteria used by different international forums such as the Stockholm Convention External link. on global restrictions concerning persistent organic pollutants (POP) and the Montreal Protocol (pdf 7 MB) External link.. Harmonising criteria is also important in order to facilitate communication with other countries concerning the criteria. Because of this are, for instance, the criteria used by the PRIO tool for PBT/vPvB substances not totally consistent with the criteria in the partial objective 3 A Non-Toxic Environment regarding PB/vPvB substances. The criteria in the PRIO tool for properties hazardous to health (allergenic, cancerogenic, mutagenic, toxic to reproduction, very high acute toxicity, specific organ toxicity after repeated exposure) en the environment (environmentally hazardous long-term effects) are consistent with the classification criteria (CLP Regulation) regarding these properties.
Substances with properties Very high acute toxicity and specific organ toxicity after repeated exposure are not considered to be phase-out substances in PRIO. These substances may be very harmful even in small doses, but they can often be handled in a way that the risks will not be unacceptably high.
The phase-out substances in PRIO are the very same once defined as “particularly hazardous substances” in the Swedish environmental objective A Non-Toxic Environment. These include CMR substances in category 1A, 1B, endocrine disruptors, particularly hazardous metals (Hg, Pb, Cd) and PBT/vPvB substances. In addition to this also ozone depleting substances and fluorinated greenhouse gases from the Kigali Amendment to The Montreal Protocol External link. are included in phase-out substances because the objective of this legislation is to phase out the substances concerned.
Concerning priority risk-reduction substances, the Swedish Chemicals Agency has made a selection from the criteria for classification and labelling of substances (please also read the CLP Regulation) that we consider to be particularly important to prioritise. These include substances of “very high acute toxicity” and “specific organ toxicity after repeated exposure”. It is motivated to overview the substitution of these substances as well.