Report 3 – Science – Definition of standardized Sampling Protocols for REACH analyses
Several Stakeholders meetings, especially during last year, have shown evidence of the need for common evaluation criteria, codification of the state of the art and provisions for sampling protocols related to different (non homogeneous) mixtures. Current situation shows a critical lack of standardized, or at least common, procedures for the sampling and analysis of articles, as defined by REACH Regulation. This creates remarkable difficulties for importers of articles, which may have a need for investigate composition, in order to provide downstream users with the required and necessary information, and to the Competent Authorities, such as Customs, which must determine whether the statements given by importers are appropriate and sufficient for REACH compliance and for a safe use of the article.
Sampling and analytical investigation of articles are relevant mainly in verifying the presence of SVHC, whose non-notification by the European producer/importer is cause of significant penalties (as an example, in Italy, from 15,000 to 90,000 euros for substance, according to D.Lgs 133/2009). There is a substantial difference of approach between producers/importers and enforcement authorities while the first must develop investigation, and therefore, sampling strategies useful to characterize large amounts of articles produced/imported at different time, authorities, normally, are content of a simplified approach to verify representativeness of sample in a limited space/time (compliance of lot produced/imported). Nevertheless, once realized sampling is critical, to perform a proper analytical verification an adequate sample preparation is needed. The next step is to evaluate which substances should be investigated. A reliable survey should be conducted on the basis of pre-assessments concerning the type of article, the material of which it is made and, if known, its production cycle. For articles of small size and with homogeneous characteristics, the analytic investigation is achievable without critical problems. For larger or non homogeneous articles, investigation is more complex and may require the planning of a multi-stages investigation. It is very important to emphasize that not for all substances there are methods that allow to detect the presence of the substance itself, or standards necessary to perform the analysis in a suitable way. Everything performed and decided must be collected into a document that shows what has been done to achieve REACH compliance. Indeed, this document allows to demonstrate and support the decisions that have been taken to carry out the verification of the SVHC in the article of interest.
- Absence of protocols for the exhaustive sampling of complex materials and articles
- Representativeness of samples from different batches of the same article in time (for importers)
- Lack of standard methods for all SVHC in Candidate List and of guidelines for analytic investigation
- Increase in requests, made by customers, for information on SVHC content or need for analytical data of substances in articles (Screening and / or targeted)
- Lack of adequate information from providers outside the EU