Risk assessment needed for Priority risk-reduction substances

If you are handling substances classified as priority risk-reduction substances, you must carry out a risk assessment. In this procedure you assess the substance concentration and exposure throughout the supply chain. Examples of questions to address are:

• Is there a risk for leaks or emissions?
• Is there a risk for skin contact?
• Is there a risk for consumption or inhalation?

Allergenic substances may, even in low concentrations, cause permanent allergies or sensibilities. A substance that might cause allergy in skin contact should not be used in a product intended for skin application for children, but may be acceptable in some other applications.

Mutagenic substances in Category 2 may, as in the case of Category 1 (see Phase-out substances), effect DNA, but it has not been proven that the effects are heritable. Since damage to the DNA can occur already after occasional exposure at low levels, substances in Category 2 are classified as priority risk-reduction substances.

Substances with High chronic toxicity and Very high acute toxicity should not be used in food but may not be considered hazardous in other products. Here you also find substances that are fatal when inhaled, in contact with skin or cause damage from occasional or repeated exposure, but if exposure can be avoided, they may be acceptable.

Potential PBT/vPvB are those substances where data or evidence are not available according to the strict methods of PBT or vPvB but there is other data, such as data that indirectly shows such properties or in other organisms.

Environmentally hazardous substances with long-term effects for organisms in water bodies should be avoided in connection with industrial emissions, agricultural drains and in products with high exposure to the environment. 

Very persistent and mobile substances are long-lasting in the environment and difficult to remove due to their mobility. These substances can also be difficult to analyze and consequently there is a risk that the abundance in the environment is underestimated. Since substances can adversely affect organisms in more ways than the death of the organism, which is what is often tested according to legal requirements, it is impossible to completely exclude toxicity. The uncertainty surrounding possible toxicity combined with the fact that the substances never disappear from the environment means that the precautionary principle should be taken into account.

Priority risk-reduction substances

These substances require risk assessment prior to use/distribution:

• Very high acute toxicity
• Allergenic substances
• Mutagenic substances in Category 2
• High chronic toxicity
• Potential PBT/vPvB
• Environmentally hazardous substances with long-term effects*

*The classification criteria for these substances corresponds to H410 or H413 according to Regulation (EU) No 1272/2008, CLP.