EU Intends to Amending FCM Regulation, to Authorise four FCMs
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On August 31, 2017, the European Commission has notifies the WTO of proposed amendments to its Regulation (EU) No 10/2011on plastic materials and articles intended to contact with food, which intends to authorise four new FCMs.

the following entries are inserted in numerical order of the FCM substance:

FCMs NO.

CAS

Name

Migration limits

Authorised purpose

1061

80512-44-3

2,4,4-trifluorobenzophen one

-

Only to be used as a co-monomer in the manufacture of polyether ether ketone plastics up to 0.3% w/w of the final material.

1063

1547-26-8

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

-

Only to be used together with tetrafluoroethylene and/or ethylene co-monomers to manufacture fluorocopolymers for application as polymer processing aid at up to 0.2% w/w of the food contact material, and when the low-molecular mass fraction below 1,500 Da in the fluorocopolymer does not exceed 30 mg/kg.

1064

39318-18-8

tungsten oxide

0.05mg/kg

Stoichiometry: WOn, n = 2.72–2.90

1065

85711-28-0

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

5mg/kg

Only to be used in the manufacture of articles made of polyolefins, and which do not come into contact with foods for which food simulant D2 is assigned in Table 2 of Annex III.

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.

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."

The entry concerning FCM substance No 856 is replaced by the following:

FCMs No

Cas

Name

Migration limits

Authorised purpose

856

25101-28-4

(butadiene, styrene, methyl methacrylate, butyl acrylate) copolymer cross-linked with divinylbenzene or 1,3-butanediol dimethacrylate

-

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 any duration of time.";

This proposal will be adopted and published by the end of 2017, then the new substances will officially implement 12 months after the regulation come into force.

C&K Testing reminds, it represents the general trend that Europe strengthen its inspection on Chinese FCM product. Withdrawing from the market, recall and destroying have caused a huge loss to Chinese enterprises. As an exporter, it should keep attention to updating regulation, strengthening the cooperation between testing services, such as C&K Testing.

|Further Information:

The European Commission notification of GSPSNEU225.pdf

|Our Services: Food and Food Contact Materials