Substances of very high concern can be identified in accordance with the following criteria of article 57 of the REACH Regulation:
- carcinogenic, mutagenic or with a harmful effect on reproduction (CMR), classified as category 1 or 2,
- imperishable, showing bioaccumulative abilities and toxic (PBT), or highly imperishable and showing high bioaccumulative abilities (vPvB), in accordance with criteria outlined in Appendix XIII of the REACH Regulation, and/or
- individually identified, if there is proven scientific evidence of a possibly severe impact on human health or the environment giving grounds for concern equal to those raised by the above mentioned substances.
Company obligations regarding placing substances on the candidate list
Due to placing substances on the candidate list, companies have certain obligations regarding not only those substances, but also mixtures (preparations) and products containing such substances.
- since the day of placing the substance on the candidate list (first substances were introduced on 28 October 2008) - every supplier of substances from the candidate list (within the European Union and the European Economic Area) is bound to provide the receivers with a Material Safety Data Sheet.
- since the day of placing the substance on the candidate list - every supplier (from the EU and the EEA) of mixtures (preparations) classified as hazardous (in accordance with 1999/45/EU), containing at least one of the substances in concentration ≥ 0.1% of mass fraction for non-gas mixtures (preparations) and ≥ 0.2% volume for gas mixtures (preparations), is bound to provide receivers, on their request, with a Material Safety Data Sheet.
- since the day of placing the substance on the candidate list - flow of information
Every supplier (from the territory of EU or EEA) of products containing substances from the candidate list in concentration > 0.1% of mass fraction is bound to provide the receiver with ample information (in their possession) or provide them free of charge upon the receiver's request within 45 days after receiving the request. Such information must contain instructions allowing for safe product usage, or at least the substance name.
- from 2011 – Agency application
Every manufacturer or importer of goods containing substances enlisted in the candidate list, whose concentration is greater than 0.1% of mass fraction and whose quantity is greater than 1 tonne per annum, is bound to provide the Agency with information in accordance with article 7 paragraph 4
• for substances enrolled to the candidate list prior to 1 December 2010, the application shall be filed no later than on 1 June 2011.
• for substance enrolled to the candidate list prior to 1 December 2010 and on that day, the application shall be filed no later than within 6 months after enrolling the substance.
Application is not required if the manufacturer or importer can exclude exposure of humans or the environment in a normal or rationally predictable usage, including disposal of the substance. In this case the manufacturer or importer provides the receiver with adequate instructions.
As required by the information transfer obligation within the supply chain including, inter alia, candidate list substances, ANWIL S.A. Company states that some of the mixtures made of PVC may contain some of the substances from the candidate list updated on 20 June 2013.
The substance concentration in the above mentioned mixtures deemed them to be classified as hazardous. Mixture receivers shall be provided with adequate information in the Material Safety Data Sheet.