For the effects of the present Regulation the following terms shall be understood as follows:
1- Chemical analysis: Measurement process through which the qualitative composition and/or quantitative composition of a sample or system is determined. It involves several stages, all equally important in assuring the reliability of the final result. The following stages can generally be identified: sampling, sample preparation (dissolution, preconcentration, separation, masking), measurement, communication of information (preparation of analysis reports and/or issuance of analysis certificates).
2- Interpretation of chemical studies: Document in which conformity of a product or substance with a reference standard or regulatory provision is expressed with public faith, value ¢15,000.
3- Analysis report: Document in which the results of the chemical, physicochemical, or metrological analyses performed on a sample are expressed with public faith.
4- Complex matrix: A gaseous, liquid, or solid medium in which the analyte is chemically combined, such that its recovery requires specific physicochemical processes (digestion, oxidation/reduction, extraction using ligands, separation using chromatographic techniques, among others) prior to its determination.
5- Simple matrix: A gaseous, liquid, or solid medium in which the analyte is not chemically combined, and can be determined using a direct analytical method.
6- Classical analytical methodology: An analytical method in which the quantity of analyte is determined using volumetric, complexometric, or gravimetric techniques.
7- Instrumental analytical methodology: An analytical methodology that allows determining the quantity of analyte present in a matrix indirectly, using an instrument that measures a physicochemical property characteristic of the element or compound to be analyzed; for example, optical and spectroscopic, electroanalytical, chromatographic, thermodynamic, energy techniques.
8- Representative sample: A sample that has been selected according to a specified procedure, whether statistical or not, and that is considered to represent the general characteristics of the lot or system to be analyzed.
9- Sampling: Professional process in which a representative sample is selected from a lot or system, for its analysis. Sampling comprises several stages:
- Pre-sampling, which is the stage in which the sampling plan is defined, the sampling equipment and the container(s) that will hold the sample are prepared, and they are kept in custody until the place where the sampling will be carried out.
- Sample collection, which is the stage in which the sample is selected in accordance with the sampling plan.
- Custody of the sample(s) at the laboratory.
10- Concentration level of the analyte: The concentration level of the analyte is the relative quantity of the analyte with respect to the quantity of the matrix in which it is found. They are classified into:
| Ultra traces | < 1 ppm | < 0.0001 % (weight/weight) |
|---|
| Traces | 1- 100 ppm | 0.0001 - 0.01 (weight/weight) |
| Residues | < 100 ppm* | < 0.01% (weight/weight) |
| Minor components | 1.0 -0.01% (weight/weight) | |
| Major components | > 1.0% (weight/weight) | |
The concentration level of the analyte is generally related to the difficulty, cost, and complexity of the chemical analysis. It is considered that classical methods are used for the analysis of minor and major components, and instrumental methods for the other concentration levels.
11- Sample preparation: Stage of the chemical analysis in which the portion of the sample analyzed is subjected to different chemical processes (dissolution, preconcentration, separation, masking) through which the analyte present in the sample is converted into a chemical species suitable for its measurement using the selected analytical methodology. Generally, the final result is an aqueous solution of the analyte.
12- Sampling time: Corresponds to the working time necessary to complete the distinct stages of the sampling process, namely, preparation, custody of containers, sample collection, and custody of samples at the laboratory.
(Note from Sinalevi: Through Board of Directors agreement number JD-13-2021-7, of session JD-13-2021 of May 19, 2021; the following definitions were approved for a clear interpretation of Executive Decree N° 33105-MINAE-S:
1. Simultaneous multiple detection technique: analysis technique with the capacity to detect two or more analytes in a single sample run.
2. Multiple detection technique: analytical technique that is capable of determining more than one analyte, by applying a change to its configuration; it may be simultaneous or not." )