Section

Detail

Annex I 

‘Union list of authorized substances’

Some items in the list of authorized substances have been amended and three types of substances have been added. Currently, there are 1077 authorized substances in the list.

Annex II

‘Restrictions on plastic materials and articles’

(1) The List of Metal Migration Substances:

The amount of metal migration requirements has increased to 24. The List defines the specific migration limit (SML) for 19 substances where some of the substances are subject to certain conditions, and an additional 5 substances where their migrations are subject to Articles 11(3) and 12. 

(2) Primary aromatic amines (PAAs):

• <0.002 mg/kg for each primary aromatic amine (PAA) listed in Appendix 8 to entry43 of Annex XVII of Regulation (EC) 1907/2006 Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)’ where there is no migration limit in Annex I.

• <0.01 mg/kg for the sum of PAAS not listed in Appendix 8 to entry 43 of Annex XVII of REACH where there is no migration limit in Annex I

Annex IV 

‘Declaration of Compliance’

Revision of the Declaration of Compliance:

(1) Adequate information relative to the substances used or products of degradation thereof for which restrictions and/or specifications are set out in Annex I and II to the Regulation to allow the downstream business operators to ensure compliance with the Regulation.

(2) At intermediate stages, this information shall include the identification and amount of substances in the intermediate material, that are subject to restrictions in Annex II, or for which genotoxicity has not been ruled out, and which originate from an intentional use during a manufacturing stage of that intermediate material and which could be present in an amount that foreseeably gives rise to a migration from the final material exceeding 0,00015 mg/kg food or food simulant.

Annex V 

‘Compliance Testing’

“The rules for the migration of plastic materials or components in food processing equipment or appliances”:

When migration testing is done under the worst foreseeable conditions, and the transfer of constituents from the equipment or appliance as a whole does not exceed the migration limits, the plastic parts or materials present in the equipment or appliance shall be considered to comply with the Regulation. When the result is not in compliance with the Regulation it shall be determined whether the source of the non- compliance is a plastic part subject to the Regulation.

“Repeated use materials and articles”:

If the material or article is intended to come into repeated contact with foods, the migration test(s) shall be carried out three times on a single sample using another portion of food simulant on each occasion. Compliance of the material or article shall then be verified on the basis of the level of the migration found in the third test and on the basis of the stability of the material or article from the first to the third migration test. The stability of the material shall be considered insufficient if migration is observed above the level of detection in any of the three migration tests, and increases from the first migration test to the third migration test. In case of insufficient stability, compliance of the material shall not be established even in case the specific migration limit is not exceeded in any of the three tests.

“Standardized Conditions for Testing the Overall Migration”:

(1) New Test Number OMO (40 °C, 30 mins) for any food contact at cold or room temperatures for no more than 30 minutes; 

(2) The words ‘or at reflux’ were added to the testing conditions in OM4.