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11
The following abbreviations appear in this column:

DIR = a) Substance included in the Directive 2002/72/EC of 6 of August 2002 (as last amended)

3AM
= b) Substance proposed to be inserted in the 3
rd
amendment of the Directive 2002/72/EC

D = c) Substance previously mentioned in former directives but later deleted for a particular reason

Only the monomers and additives which are mentioned in the other document "EU SUBSTANCES"
(document available on the website) are considered substances approved at EU level. The other
appearing in the table below are substances which likely have been approved at national level but
which will not be included in the EU lists if the data requested by EFSA is not supplied on time (see
also paragraph 3 of the explanatory note of this document)

Column 6 ("RESTRICTIONS AND SPECIFICATIONS")
This column contains the restrictions and/or specifications for the use of the substance as they appear
in the Directive 2002/72/EC and amendments. See also Appendix 2 (definition of the SCF lists) and
Appendix 3 (notes related to the column "restrictions and/or specifications").
It may include:
specific migration limit (SML),
maximum permitted quantity of the substance in the finished material or article (QM),
maximum permitted quantity of the substance in the finished material or article expressed as
mg per 6 dm
2
of the surface in contact with foodstuffs (QMA),
other restriction specifically mentioned,
specifications related to the substance or to the polymer.

For some of the substances the Specific migration limits (SML) are specified. SML are obtained by the
Commission Services using the following conversions:
1) For substances with an ADI/TDI established - by multiplying the ADI/TDI values by a factor of 60.
This factor is derived from the convention that a person of 60 kg daily could ingest up to 1 kg of
foodstuffs in contact with a plastic article always containing the considered substance at a
concentration corresponding to the SML;
2) For substances where an ADI/TDI is not established ­ For these cases, restrictions can be
mentioned, frequently derived from reduced toxicity dossiers, leading directly to fixed migration limits
e.g. R=0.05 or R=5mg/kg food or food simulant. For these substances the SML generally corresponds
to the restriction (=R) which appears in the toxicological SCF/EFSA assessment.

Sometimes the QMA is mentioned. The relationship between the two restrictions SML and QMA is
QMA = SML*kg/6dm
2
. The value is derived from the SML by assuming a) that the substance migrates
completely (% of migration) and b) S/V report equal 6 dmē/1 liter.

For substances where the specific migration limits or other restrictions, are not indicated, the overall
migration limit of 60 mg/kg or 10 mg/dm
2
, according to the case, is applied.

For other abbreviations see explanation for column 8