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- Practical Guide -
Page 53 of 153
c) The resulting value obtained under b) shall be lower than the SML.
The term "analytical tolerance" is not a technically defined parameter such as "
repeatability " or "reproducibility". It was introduced in the Directive to avoid a choice
between the two mentioned parameters. It encompasses all the possible sources of
imprecision or inaccuracy during sampling, treatment and analysis.
It does, however, give rise to the question of which limit should not be exceeded to ensure
the compliance with the overall migration limit? The answer depends on whether a
substraction is made from the value of the analytical tolerance (=3 mg/dmē) during
analysis. If the factor of 3 is not substracted the limit not to be exceeded is 13 mg/dmē. If
the value 3 is substracted the limit to be not exceeded 10 mg/dmē. It is irrelevant to the
verification of compliance if the real value of the analytical tolerance is greater or less
than 3.
9.
Further comments on Directive 2002/72/EC [A29]
9.1 Scheme describing the step sequence to apply the Directive
A simple scheme explaining the sequence of steps involved in the application of Directive
2002/72/EC [A29] and its amendments is given overleaf.
9.2 Compliance with the Directive
To certify compliance, it should be identified whether:
A.
The plastic material or article is within the scope of the Directive according to Art 1.2.
and the definitions given or whether it is beyond the scope of the Directive as indicated
in Art. 1.3. and 1.4.
B.
The monomer(s) and additives used to manufacture the plastic article either
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Are contained in Sections A or B of Annex II and III to the Directive, or
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Not or only partially contained in lists A or B, but are accepted at the national
level as a new substance, in which case the provisions of Art. 4 of Directive
89/109/EEC [A11] have to be taken into account;
C.
The material or article fulfils the limit of overall migration and the monomers and
additives comply with SML, QM or QMA restrictions.