legislation-obligation
legislation-obligation
Substance Regulatory Obligations
1,3-dioxepane
EC number: 208-015-6
CAS number: 505-65-7
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 | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
1,4-butanediol formal |
505-65-7 |
344 |
13810, 21821 |
no |
yes |
no |
0.05 mg/kg |
V21 In case of reaction with foods or simulants verification of compliance shall include verification that the migration limits of the hydrolysis products, formaldehyde and 1,4-butanediol, are not exceeded. |
Details | ||||||
|
1,4-butanediol formal |
505-65-7 |
344 |
13810, 21821 |
no |
yes |
no |
G15 Group Restriction No. 15 corresponds to FCM substance No. 98,196,344. Group restriction specification is expressed as formaldehyde. |
98,196,344 |
15 mg/kg |
V21 In case of reaction with foods or simulants verification of compliance shall include verification that the migration limits of the hydrolysis products, formaldehyde and 1,4-butanediol, are not exceeded. |
Details | ||||
|
1,4-butanediol formal |
505-65-7 |
344 |
13810, 21821 |
no |
yes |
no |
G30 Group Restriction No. 30 corresponds to FCM substance No. 254,344,672. Group restriction specification is expressed as 1,4-butanediol. |
254,344,672 |
5 mg/kg |
V21 In case of reaction with foods or simulants verification of compliance shall include verification that the migration limits of the hydrolysis products, formaldehyde and 1,4-butanediol, are not exceeded. |
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 | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
1,4-butanediol formal |
505-65-7 |
344 |
21821 13810 |
no |
yes |
no |
0.05 mg/kg |
V21 In case of reaction with foods or simulants verification of compliance shall include verification that the migration limits of the hydrolysis products, formaldehyde and 1,4-butanediol, are not exceeded. |
Details | |||||||
|
1,4-butanediol formal |
505-65-7 |
344 |
21821 13810 |
no |
yes |
no |
G30 Group Restriction No. 30 corresponds to FCM substance No. 254,344,672. Group restriction specification is expressed as 1,4-butanediol. |
254,344,672 |
5 mg/kg |
V21 In case of reaction with foods or simulants verification of compliance shall include verification that the migration limits of the hydrolysis products, formaldehyde and 1,4-butanediol, are not exceeded. |
As 1,4-butanediol |
Details | ||||
|
1,4-butanediol formal |
505-65-7 |
344 |
21821 13810 |
no |
yes |
no |
G15 Group Restriction No. 15 corresponds to FCM substance No. 98,196,344. Group restriction specification is expressed as formaldehyde. |
98,196,344 |
15 mg/kg |
V21 In case of reaction with foods or simulants verification of compliance shall include verification that the migration limits of the hydrolysis products, formaldehyde and 1,4-butanediol, are not exceeded. |
As formaldehyde |
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.