Commission Regulation (EU) 2019/37 of 10 January 2019 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food

Jurisdiction:  EU

Commencement:  31^st January 2019

Amends:   Regulation (EU) No.10/2011 on plastic materials and articles intended to come into contact with food

 

Mini Summary

Plastic materials and articles that come into contact with food may transfer toxic substances to them and may be a risk to human health. This regulation introduces migration limits for substances used in such packaging and lays down conditions for their use to ensure food safety.

Amendment

Makes amendments to Annex  I and III of the Regulation.

Annex I (Substances)

Table 1 (List of EU authorised substances) is amended to replace the entries concerning Food Contact Materials (FCM) substances:

• No. 467 (crotonic acid), to reflect the substance being included in a group restriction.
• No. 744 (3-hydroxybutanoic acid-3- hydroxypentanoic acid, copolymer), to reflect the substance being included in a group restriction.
• No. 1066 (1,2,3,4-tetrahydronaphthalene-2,6-dicarboxylic acid, dimethyl ester), to remove an administrative error.
• No. 1068 ([3-(2,3-epoxypropoxy)propyl]trimethoxy silane), to clarify the intended uses.

 

Table 1 is also amended to insert entries for FCM substances:

• No. 1059 (poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate)),
• No. 1067(dimethyl carbonate)
• No. 1069 (isobutane).

 

These substances are now ‘authorised substances’.

In Table 2 (Group restriction of substances), entry No. 35 is added to include a  group restriction for FCM substances: No’s 467, 744 and 1059.

In Table 3 (Notes on verification of compliance), which contains rules for testing for compliance of the substance with specific migration limits (SMLs) or other restrictions, entry No. 27 is added which requires a description of the method and a calibration sample to be provided for oligomer migration compliance, if required.

In Table 4 (Detailed specification on substances), the entry for FCM No. 744 is updated to change the compliance verification method from food contact surface area (QMA) to specific migration limit (SML) following an earlier amendment to the Regulation.

 

Annex III (Food Simulants)

Table 3 (Food simulant assignment for demonstrating compliance with the overall migration limit) is amended to correct an error and clarify that:

• Row 3 is in relation to aqueous and alcoholic foods and milk products with a pH equal or greater than pH 4.5; and
• Row 4 is in relation to aqueous and alcoholic foods and milk products with a pH less than 4.5.

Plastic materials and articles complying with Regulation (EU) No 10/2011 as applicable before this Regulation came into force (31st January 2019) may be placed on the market until 31st January 2020 and may remain on the market until exhaustion of stocks

Link to full government text