Food Contact Plastic Materials and Articles Regulation (EU) 10/2011 Amendment – (EU) 2020/1245

1. Added the detection limit (DL: 0.002 mg/kg food or food simulant) of 1,3-phenylenediamine (FCM No 236)

2. Added the specific migration limit (SML) (<0.04 mg/kg food or food simulant) of antimony trioxide (FCM No 398)

3. Added three new substances into the union list of authorized substances

i. Montmorillonite clay modified with hexadecyltrimethylammonium bromide (FCM No 1075)

ii. Phosphorous acid, triphenyl ester, polymer with alpha-hydro-omega-hydroxypoly [oxy(methyl-1,2-ethanediyl)], C10-16 alkyl ester (FCM No 1076)

iii. Titanium dioxide surface treated with fluoride-modified alumina (FCM No 1077)

1. Added 15 elements with specific migration limits into the list of restrictions on plastic materials and articles. (Table 1)

2. Lowered the detection limit to 0.002 mg/kg food or food simulant of each individual primary aromatic amine (PAA) listed in entry 43 to Appendix 8 of Annex XVII to Regulation (EC) No 1907/2006

3. Set the specific migration limit (<0.01 mg/kg food or food simulant) of the sum of PAAs which not listed in entry 43 to Appendix 8 of Annex XVII to Regulation (EC) No 1907/2006

1. For the food processing equipment or an appliance, the migration test shall be conducted on the whole equipment or appliance at the worst foreseeable condition

2. For repeated use material and articles, the migration test shall be carried out three times and the value shall not be increased in the subsequent tests

3. Added overall migration testing condition OM0 (30 min. for 40°C) for any plastic materials and articles intended to contact with food at cold or ambient temperature and for less than 30 min.

4. Amended the condition of OM4 to 1 hour at “100°C or at reflux”