# Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance), Annex II: Restrictions on plastic materials and articles

Extent: E+W+S+N.I.

The following restrictions on plastic materials and articles apply:
1..Plastic materials and articles shall not release the substances in Table 1 below in quantities exceeding the specific migration limits expressed in mg/kg food or simulant specified in column (3), and subject to the remarks in Column (4).
Substances listed in Table 1 shall only be used in accordance with the compositional requirements set out in Chapter II. If Chapter II does not provide a basis for the authorised use of such a substance, that substance may only be present as an impurity subject to the restrictions specified in Table 1.
Table 1
General list of migration limits for substances migrating from plastic materials and articles
ND: Not Detectable; detection limit assigned in accordance with second subparagraph of Article 11(4); LOD: specified Limit of Detection.
Remarks
(1) The migration is subject to Article 11(3) and Article 12
(2) ... SML might be exceeded at very high temperature
(3) To verify compliance with the Regulation, the detection limit of 0,01 mg/kg shall apply for total chromium. However if the operator that placed the material on the market can prove on the basis of pre-existing documentary evidence that the presence of hexavalent chromium in the material is excluded because it is not used or formed or during the entire production process, a limit for the total chromium of 3,6 mg/kg food shall apply.
(4)The lanthanide substances europium, gadolinium, lanthanum, and/or terbium can be used in accordance with Article 6(3)(a) provided that:
(a)The sum of all lanthanide substances migrating to the food or food simulant does not exceed the specific migration limit of 0,05 mg/kg; and
(b)analytical evidence using a well described methodology demonstrating that the lanthanide substance(s) used are present in dissociated ionic form in the food or the food simulant, forms part of the documentation referred to in Article 16.
(1)
(2)
(3)
(4)
Name
Salts allowed in accordance with Article 6(3)(a)
SML [mg/kg food or food simulant]
Remark
Aluminium
yes
1
Ammonium
yes
-
(1)
Antimony
no
0,04
(2)
Arsenic
no
ND
Barium
yes
1
Cadmium
no
ND (LOD 0,002)
Calcium
yes
-
(1)
Chromium
no
ND
(3)
Cobalt
yes
0,05
Copper
yes
5
Europium
yes
0,05
(4)
Gadolinium
yes
0,05
(4)
Iron
yes
48
Lanthanum
yes
0,05
(4)
Lead
no
ND
Lithium
yes
0,6
Magnesium
yes
-
(1)
Manganese
yes
0,6
Mercury
no
ND
Nickel
no
0,02
Potassium
yes
-
(1)
Sodium
yes
-
(1)
Terbium
yes
0,05
(4)
Zinc
yes
5
2..Primary aromatic amines (‘PAAs’) listed in entry 43 to Appendix 8 of Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council and for which no migration limit is specified in an authorisation for the substance concerned shall not migrate or shall not otherwise be released from plastic materials and articles into food or food simulant. They shall not be detectable using analytical equipment with a limit of detection of 0,002 mg/kg food or food simulant applied to each individual primary aromatic amine (‘PAA’), in accordance with Article 11(4).
For PAAs not listed in entry 43 to Appendix 8 of Annex XVII to Regulation (EC) No 1907/2006, but for which no specific migration limit is specified in the authorisation concerned, compliance with Article 3 of Regulation (EC) No 1935/2004 shall be verified in accordance with Article 19. The sum of those PAAs shall however not exceed 0,01 mg/kg in food or food simulant.

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Source: https://www.legislation.gov.uk/eur/2011/10/annex/II (the official version)
Page: https://openlegislation.uk/eu-regulation-2011-10/annex-II
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.