plastic-subs-restricted-ann-2

plastic-subs-restricted-ann-2

FCM and Articles Regulation, Annex II - Restricted Substances

EU. Restricted Substances: Annex II, Plastics Food Contact Regulation 10/2011/EU, as amended by Regulation 2020/1245/EU, 3 September 2020

This list contains the Annex II substances subject to general restrictions for use in plastic materials and articles intended to come into contact with food. Each listed substance includes specific migration limit that must not be exceeded.

Last updated 22 September 2023. Database contains 26 unique substances/entries.

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Showing 26 results.

Substance Name	EC No.	CAS No.	SML (mg/kg)	Notes
Primary aromatic amines (PAAs) listed in entry 43 to Appendix 8 of Annex XVII to Regulation (EC) No 1907/2006 and for which no migration limit is specified in Table 1 of Annex I (Regulation 10/2011/EU)	-	-	0.002 mg/kg	ND Specific Migration Limit (SML): Not Detectable; detection limit assigned in accordance with second subparagraph of Article 11(4)
Primary aromatic amines (PAAs) not listed in entry 43 to Appendix 8 of Annex XVII to Regulation (EC) No 1907/2006 and for which no migration limit is specified in Table 1 of Annex I (Regulation 10/2011/EU)	-	-	0.01 mg/kg	ND Specific Migration Limit (SML): Not Detectable; detection limit assigned in accordance with second subparagraph of Article 11(4)
Ammonium	-	14798-03-9		1a Substance listed in Table 1. Plastic materials and articles shall not release the substances in Table 1 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). 1b 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.
Aluminium	231-072-3	7429-90-5	1 mg/kg	1a Substance listed in Table 1. Plastic materials and articles shall not release the substances in Table 1 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). 1b 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.
Antimony	231-146-5	7440-36-0	0.04 mg/kg	1a Substance listed in Table 1. Plastic materials and articles shall not release the substances in Table 1 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). 1b 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.
Arsenic	231-148-6	7440-38-2	0.01 mg/kg	ND Specific Migration Limit (SML): Not Detectable; detection limit assigned in accordance with second subparagraph of Article 11(4) 1a Substance listed in Table 1. Plastic materials and articles shall not release the substances in Table 1 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). 1b 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.
Barium	231-149-1	7440-39-3	1 mg/kg	1a Substance listed in Table 1. Plastic materials and articles shall not release the substances in Table 1 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). 1b 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.
Cadmium	231-152-8	7440-43-9	0.002 mg/kg	ND Specific Migration Limit (SML): Not Detectable; detection limit assigned in accordance with second subparagraph of Article 11(4) LOD Specific Migration Limit (SML): Specified Limit of Detection 1a Substance listed in Table 1. Plastic materials and articles shall not release the substances in Table 1 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). 1b 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.
Calcium	231-179-5	7440-70-2		1a Substance listed in Table 1. Plastic materials and articles shall not release the substances in Table 1 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). 1b 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.
Chromium	231-157-5	7440-47-3	0.01 mg/kg	ND Specific Migration Limit (SML): Not Detectable; detection limit assigned in accordance with second subparagraph of Article 11(4) 1a Substance listed in Table 1. Plastic materials and articles shall not release the substances in Table 1 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). 1b 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.
Cobalt	231-158-0	7440-48-4	0.05 mg/kg	1a Substance listed in Table 1. Plastic materials and articles shall not release the substances in Table 1 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). 1b 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.
Copper	231-159-6	7440-50-8	5 mg/kg	1a Substance listed in Table 1. Plastic materials and articles shall not release the substances in Table 1 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). 1b 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.
Europium	231-161-7	7440-53-1	0.05 mg/kg	1a Substance listed in Table 1. Plastic materials and articles shall not release the substances in Table 1 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). 1b 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.
Gadolinium	231-162-2	7440-54-2	0.05 mg/kg	1a Substance listed in Table 1. Plastic materials and articles shall not release the substances in Table 1 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). 1b 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.
Iron	231-096-4	7439-89-6	48 mg/kg	1a Substance listed in Table 1. Plastic materials and articles shall not release the substances in Table 1 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). 1b 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.
Lanthanum	231-099-0	7439-91-0	0.05 mg/kg	1a Substance listed in Table 1. Plastic materials and articles shall not release the substances in Table 1 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). 1b 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.
Lead	231-100-4	7439-92-1	0.01 mg/kg	ND Specific Migration Limit (SML): Not Detectable; detection limit assigned in accordance with second subparagraph of Article 11(4) 1a Substance listed in Table 1. Plastic materials and articles shall not release the substances in Table 1 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). 1b 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.
Lithium	231-102-5	7439-93-2	0.6 mg/kg	1a Substance listed in Table 1. Plastic materials and articles shall not release the substances in Table 1 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). 1b 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.
Magnesium	231-104-6	7439-95-4		1a Substance listed in Table 1. Plastic materials and articles shall not release the substances in Table 1 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). 1b 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.
Manganese	231-105-1	7439-96-5	0.6 mg/kg	1a Substance listed in Table 1. Plastic materials and articles shall not release the substances in Table 1 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). 1b 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.
Mercury	231-106-7	7439-97-6	0.01 mg/kg	ND Specific Migration Limit (SML): Not Detectable; detection limit assigned in accordance with second subparagraph of Article 11(4) 1a Substance listed in Table 1. Plastic materials and articles shall not release the substances in Table 1 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). 1b 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.
Nickel	231-111-4	7440-02-0	0.02 mg/kg	1a Substance listed in Table 1. Plastic materials and articles shall not release the substances in Table 1 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). 1b 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.
Potassium	231-119-8	7440-09-7		1a Substance listed in Table 1. Plastic materials and articles shall not release the substances in Table 1 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). 1b 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.
Sodium	231-132-9	7440-23-5		1a Substance listed in Table 1. Plastic materials and articles shall not release the substances in Table 1 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). 1b 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.
Terbium	231-137-6	7440-27-9	0.05 mg/kg	1a Substance listed in Table 1. Plastic materials and articles shall not release the substances in Table 1 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). 1b 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.
Zinc	231-175-3	7440-66-6	5 mg/kg	1a Substance listed in Table 1. Plastic materials and articles shall not release the substances in Table 1 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). 1b 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.

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