 
EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10224/2019 ANNEX 
(POOL/E2/2019/10224/100224 -EN 
ANNEX.doc) D061326/03  
[…](2019) XXX  draft  
ANNEX  
 
ANNEX  
to the  
COMMISSION REGULATION (EU) .../...  
amending Regulation (EU) No 10/2011 on plastic materials and articles intended to come 
into contact with food  
   
EN 1  EN ANNEX  
 in Annex I, Table 1 , is amended as follows:  
the entry concerning FCM substance No 1059, is replaced by the following:  
“1059   147398 -
31-0 Poly((R) -3-
hydroxybutyrate -co-
(R)-3-
hydroxyhexanoate)  no yes no  (35) 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, i ncluding hot 
fill or a short 
heating up phase . 
The migration of all 
oligomers with a 
molecular weight 
below 1 000 Da 
together shall not 
exceed 5,0 mg/kg 
food.  (23)” 
 