The European Commission has proposed to amend Regulation (EU) No 10/2011 on plastic food contact materials and articles. Here is the summary of the proposal:

Annex I - Table 1: Union list of authorised materials

1. Amendments to existing authorised substances

a. Entry 236: 1,3-phenylenediamine - Adding a detection limit of 0.002 mg/kg food or food simulant

b. Entry 398: Antimony trioxide - Specific migration limit of 0.04 mg/kg food or food simulant and its note on compliance verification will be included in Annex II

2. Additions of authorised substances

a. Entry 1075: Montmorillonite clay modified with hexadecyltrimethylammonium bromide

b. Entry 1076: Phosphorous acid, triphenyl ester, polymer with alpha-hydro-omega-hydroxypoly[oxy(methyl-1,2-ethanediyl)], C10-16 alkyl ester, CAS No. 1227937-46-3

c. Entry 1077: Titanium dioxide surface-treated with fluoride-modified alumina

Annex II - Specific migration limits

1. There will be a new table on the general list of migration limits:

Here are some key points related to the above table:

a. The existing migration limits remain unchanged.

b. Article 6(3)(a) regarding the derogation of certain salts of authorised acids, phenols and alcohols will be incorporated into the second column of the above table.

c. There are additional remarks for some limits. The significant ones are:

i. For total chromium, the detection limit of 0.01 mg/kg shall apply. However, if the operator who place the food contact material on the market can prove that the presence of chromium (VI) is excluded, a limit of 3.6 mg/kg shall apply.

ii. For lanthanide substances (europium, gadolinium, lanthanum and terbium),

·The sum of all lanthanide substances migrating to food or food simulant shall not exceed the specific migration limit of 0.05 mg/kg

·There shall be analytical evidence using a well described methodology demonstrating the lanthanide substance(s) used are present in dissociated ionic form in the food or food simulant. The evidence shall form part of the supporting documentation referred to in Article 16.

2. The detection limit for primary aromatic amines (PAAs) will be amended as follows:

a. For PAAs listed in entry 43 to Appendix 8 of Annex XVII to REACH Regulation (EC) No 1907/2006, if no migration limit is specified in Table 1 of Annex I to Regulation (EU) No 10/2011, they shall not be detectable with a limit of detection of 0.002 mg/kg food or food simulant applied to each individual PAA.

b. For PAAs other than those mentioned in point (a), if no migration limit is specified in Table 1 of Annex I to Regulation (EU) No 10/2011, the sum of those PAAs shall not exceed 0.01 mg/kg in food or food simulant.

Annex IV - Declaration of compliance

The information requirements under point 6 will be strengthened to ensure adequate information on the presence of substances listed in Annex II.

Annex V - Compliance testing

1. Testing rules will be added for food processing equipment and appliances.
2. For repeated use materials and articles, the regulation will require the specific migration between subsequent tests does not increase.
3. A new standard testing condition (OM0) for overall migration will be added: 30 minutes at 40°C for materials and articles intended for use only at cold or ambient temperatures for 30 minutes or less.
4. For the overall migration testing condition OM4, reflux condition will be available as an option when testing at 100°C is technically difficult.
5. The amendment corrects some of the wording related to overall migration testing.

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