legislation-obligation
legislation-obligation
Substance Regulatory Obligations
Poly(3-Hydroxybutyrate-co-3-Hydroxyhexanoate)
EC number: -
CAS number: 147398-31-0
Regulatory obligations may exist for this substance under the legislations under ECHA’s remit or for which ECHA has delegated tasks (i.e. REACH, CLP, BPR, PIC, CAD / CMD, WFD, and POPs). Please check the substance Infocard.
FCMs Recycled Plastic & Articles Regulation - Annex I - Authorised Use
This list contains the Annex I Plastic Food Contact Materials (FCMs) authorised for use in the European Union under Regulation 10/2011/EU. Pursuant to Art. 4(b) of Directive 282/2008/EC on recycled plastic FCMs, plastic recycling processes can only be authorised if input originates from plastic materials and articles manufactured in accordance with EU legislation on plastic food contact materials and articles.
| Name | CAS | Physical form | FCM No | Ref No. | Additive or PPA | Use as monomer/macromolecule | FRF applicable | SML (mg/kg) | SML(T) Group Restriction No | SML(T) Group FCM substances | SML(T) (mg/kg) | Restriction(s) | Notes on verification | Notes | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) |
147398-31-0 |
1059 |
no |
yes |
no |
G35 Group Restriction No. 35 corresponds to FCM substance No. 467,744,1059. Group restriction specification is expressed as crotonic acid. |
467,744,1059 |
0.05 mg/kg |
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. |
V23 When a final material/article containing this substance is placed on the market, a well described method suitable for use by a competent authority to determine oligomer migration compliance with the restrictions in column 10 Table 1 shall be part of the supporting document referred to in Art. 16. Reference shall be made if an adequate method is publicly available. If it requires a calibration sample, a sufficient sample shall be supplied to the competent authority on its request. |
Details | ||||
FCM and Articles Regulation, Annex I - Authorised Substances
This list contains the Union list of authorised monomers, other starting substances, macromolecules obtained from microbial fermentation, additives and polymer production aids. It is taken from Annex I of the Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food.
| Name | CAS | FCM No | Ref No. | Additive or PPA | Use as monomer/macromolecule | FRF applicable | SML (mg/kg) | SML(T) Group Restriction No | SML(T) Group FCM substances | SML(T) (mg/kg) | Restriction(s) | Notes on verification | Notes | Physical form | Expressed As | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) |
147398-31-0 |
1059 |
no |
yes |
no |
G35 Group Restriction No. 35 corresponds to FCM substance No. 467,744,1059. Group restriction specification is expressed as crotonic acid. |
467,744,1059 |
0.05 mg/kg |
The substance is a macromolecule obtained from microbial fermentation. Only to be used at temperature conditions not exceeding the conditions defined in point 2.1.4(d) of Annex V. The migration of all oligomers with a molecular weight below 1 000Da shall not exceed 5.0 mg/kg food. |
V23 When a final material/article containing this substance is placed on the market, a well described method suitable for use by a competent authority to determine oligomer migration compliance with the restrictions in column 10 Table 1 shall be part of the supporting document referred to in Art. 16. Reference shall be made if an adequate method is publicly available. If it requires a calibration sample, a sufficient sample shall be supplied to the competent authority on its request. |
As crotonic acid |
Details | ||||
Recycled Plastic FCMs - Regulation (EU) 2022/1616
The list contains the Union list of authorised substances for the purposes of compositional requirements related to recycled plastic FCMs. The list is taken from Annex I to Commission Regulation (EU) No 10/2011. Recycled plastic FCMs shall comply with the requirements set out in Regulation (EU) No 10/2011. In addition, plastic waste inputs shall originate only from plastic materials and articles manufactured in accordance with Regulation (EU) No 10/2011.
| Additive or PPA | Expressed As | FCM No | FRF applicable | |
|---|---|---|---|---|
|
no |
As crotonic acid |
1059 |
no |
Details |