BAKGRUNN (fra kommisjonsbeslutningen)

(1)    Testing and acceptance methodologies should be established for assessing the safe use of starting substances, compositions and constituents. 
 

(2)    Inclusion or removal of an entry in a European positive list should be based on the identification of the starting substance, composition or organic cementitious constituent and the identification of its intended use. The physico-chemical properties of the starting substance, composition or organic cementitious constituent necessary for carrying out migration testing should be established. The starting substance, composition or organic cementitious constituent should be tested for migration. 
 

(3)    Inclusion or removal of an entry in a European positive list should be based on the identification of chemical species that are relevant for the acceptance methodology, or risk assessment, because they may have an impact on the safe use of a material or product, such as an impurity, the constituent of a starting substance or a degradation product. These relevant chemical species should be determined on the basis of the information on the identification of the starting substance, composition or constituent and on the basis of its intended use as well as the results of migration testing. The toxicological properties of these relevant chemical species should also be identified.
 

(4)    For proportionality and efficiency reasons, testing for physico-chemical properties and toxicological properties as well as risk assessment should be more limited if a similar assessment has already been carried out at Union level within a reasonable period of time or if the substance has a stringent classification in Part 3 of Annex VI of Regulation (EU) 1272/2008 or the applicant proposes such classification. For proportionality  reasons, the testing requirements for toxicological properties should be stricter where there is a high exposure to a certain substance through migration. 

(5)    In order to respect the precautionary principle and in order to cover the potential for significant exposure over a long period of time, the acceptance methodology should be based on a worst-case risk assessment of each relevant chemical species. The risk assessment should consider migration, including release, under the worst foreseeable conditions of use. In particular, the risk assessment should consider the expected long-term exposure to materials or products in contact with water intended for human consumption and, in the case of metallic compositions, the differences in the properties, such as composition and corrosivity, of all water in the Union intended for human consumption.   
 

(6)    Economic operators and relevant authorities should be allowed sufficient time to adapt their national methodologies to the methodologies set out in this Decision. The application of this Decision should therefore be deferred.
 

(7)    The measures provided for in this Decision are in accordance with the opinion of the Committee referred to in Article 22(1) of Directive (EU) 2020/2184.