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EU: Amendment to Commission Regulation (EU) No 10/2011 on plastic

February 2018- Relevant for: Hardlines

Back in November 2017, we brought to your attention1 that Regulation (EU) No 10/20112 would be amended. On 19 January 2018, the European Commission (EC) published Regulation (EU) 2018/793 (‘The Regulation’) in the Official Journal of the European Union (OJEU), amending Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food.

The Regulation will enter into force on 8 February 2018. Plastic materials and articles complying with Regulation (EU) No 10/2011 as applicable before the entry into force of the Regulation may be placed on the market until 9 February 2019 and may remain on the market until exhaustion of stocks.

The following tables are the details of the amendments.

Table 1 – Additional substances added to Table 1, Annex I of Regulation (EU) No 10/2011.

FCM No.

CAS No.

Substance name

1061

80512-44-3

2,4,4-tri-fluorobenzophenone

1063

1547-26-8

2,3,3,4,4,5,5-heptafluoro-1-pentene

1064

39318-18-8

tungsten oxide

1065

85711-28-0

mixture of methyl branched and linear C14-C18 alkanamides, derived from fatty acids

 

Table 2 – Changes made to Table 1, Annex I of Regulation (EU) No 10/2011.

FCM No.

Previous

Amended

856

Only to be used in rigid poly (vinyl chloride) (PVC) at a maximum level of 12% at room temperature or below

Only to be used in:

  • rigid poly (vinyl chloride) PVC at a maximum level of 12% at room temperature or below;

or

  • at up to 40% w/w in blends of styrene acrylonitrile copolymer (SAN)/poly (methyl methacrylate) (PMMA) repeat-use articles at room temperature or below, and when either in contact only with aqueous, acidic and/or low alcoholic (<20%) foodstuffs for less than 1 day, or when in contact only with dry foodstuffs for and duration of time.

 

Table 3 – Additions made to Table 3, Annex I of Regulation (EU) No 10/2011.

Note No.

Notes on verification of compliance

25

When used as reheat agent in polyethylene terephthalate (PET) verification of compliance with the specific migration limit is not required; in all other cases compliance with the specific migration limit shall be verified in accordance with Article 18; the specific migration limit is expressed as mg tungsten/kg food.

26

Migration of stearamide, listed in Table 1 under FCM substance No 306 to which no specific migration limit applies, shall be excluded from verification of the compliance of the migration of the mixture with the specific migration limit laid down for the mixture

   

[1] The proposed amendments published in E-ssentials Vol. 18 (2017)
[2] Regulation (EU) 10/2011 (consolidated)
[3] Regulation (EU) 2018/79

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