Methodology for recommending analytical methods to check compliance with REACH Annex XVII restrictions
This document presents a methodology to recommend analytical methods for checking the compliance with REACH Annex XVII restrictions.
The basic steps of the methodology are:
1. To define what are the functional qualities (characteristics) of an analytical method that can be attributed to the method in order to know how it works. General principles applied in widely accepted international standards as well as in other legislation fields have been considered and a set of key characteristics have been identified for the purpose of assessing the suitability of an analytical method to check compliance with restrictions on chemicals under REACH Annex XVII. The characteristics identified are: applicability, limit of detection, recovery, reproducibility and measurement uncertainty.
2. For each of the selected characteristics, to agree upon generally acceptable performance requirements for analytical methods to be recommended. Widely accepted criteria have been applied to define the requirements for the considered characteristics of an analytical method to be suitable for checking compliance with REACH Annex XVII restrictions. Due to the broad ranges of products covered by REACH Annex XVII, and to the different limit values (including a total ban for certain substances) set forth in different entries, it is deemed necessary to foresee a case by case approach where appropriate.
The methodology is then implemented by the Forum WG Group on Enforceability of Restrictions to elaborate the Compendium of analytical methods recommended by the Forum to check compliance with REACH Annex XVII restrictions. A data gathering on the available analytical methods within MS public and private laboratories and within the ECHA Accredited stakeholders linked laboratories is conducted based on the present methodology.
A data analysis follows, where the performance of gathered methods is assessed according to the proposed requirements. Such requirements may be applied on a case-by-case basis in the light of the technical issues encountered and taking into consideration the available sample preparation and analysis protocols and techniques. Once adopted by the Forum, the Compendium of recommended analytical methods to check compliance with REACH Annex XVII restrictions is published on the ECHA website and is revised at regular intervals to reflect changing technical standards, new available methods as well as modification of existing ones. The Compendium of analytical methods recommended by the ECHA Forum for checking compliance with Annex XVII restrictions will include:
- Official methods (with references published in REACH legal text);
- Standard methods;
- Methods published by a recognized technical organisation, a national or EU reference laboratory (EPA, etc.);
- Internal methods, which have been considered fit for purpose according to the set of performance criteria.