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EU: FCM plastic regulation no 10/2011 amends the entry in Annex I

 August 2019 - Relevant for: Hardlines

The Official Journal of the European Union (OJEU) published Regulation (EU) 2019/1338 to update an authorised food contact materials (FCM) substance on Plastic Regulation (EU) No 10/2011. This updates the requirement of that substance listed on the table 1 of Annex I.

The amendment will apply from 29 August 2019. Existing stocks with previous authorised substance can still allow to be placed on the market until 29 August 2020 and may remain on the market until exhaustion.

According to the FCM Plastic Regulation, Annex I contains a list of authorised substances which may be used in the manufacture of plastic materials and articles intended to come into contact with food. The European Food Safety Authority has adopted a new favourable scientific opinion. Hence, the requirement of the substance, poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) (FCM substance No 1059, CAS number 147398-31-0), is amended. This substance is a biodegradable copolymer which is produced by fermentation of palm oil using a genetically modified microorganism.

FCM Substance No.





Only to be used alone or blended with other polymers in contact with foods for which food simulant E is assigned in Table 2 of Annex III.

Only to be used either alone or blended with other polymers in contact with all foods under contact conditions of up to 6 months and/or 6 months and more, at room temperature or below, including hot fill or a short heating up phase. The migration of all oligomers with a molecular weight below 1 000 Da shall not exceed 5.0 mg/kg food.

You can also find more information on this regulatory update in our Food & Health E-ssentials here.

[1] Regulation (EU) 2019/1338

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