Eurofins | Newsflash - November 2018 | Food Contact Materials
Germany
Products and materials in contact with Drinking water Products and materials in contact with Drinking water On 24th September 2018, the German Federal Ministry of Economics and Energy notified to the European Commission two draft documents related to materials and products in contact with drinking water.
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UK
Consultation about FCM regulation without Brexit 's agreement
On 14th October 2018, UK FSA (Food Standards Agency) published a consultation: “Proposed approach to retained EU law for food and feed safety and hygiene”.
The main points of this consultation are food and animal feed, but FSA suggested to keep all the food contact materials (FCM) regulations from the EU in place in case UK will leave the EU in a no-deal scenario. Interestingly, the aim of this document, and also the request to the stakeholders, is not to discuss whether the EU regulations should be taken over but which responsibilities should be transferred from European institutions to British institutions.
For more information about this consultation click here.
US
New substances for the FDA inventory of Effective Food Contact Substances
The following substances have been recently added to the Inventory of Effective Food Contact Substances (FCS) Notifications of the U.S. Food and Drug Administration (FDA).
FCN number |
Substances |
Date |
Tricyclodecanedimethanol (TCDM) (CAS Reg. Nos. 26896-48-0 and 26160-83-8) |
September 29, 2018 |
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Polypropylene (CAS Reg. No. 9003-07-0) |
September 21, 2018 |
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Ethylene phthalate polymers modified with 1,2,4,5-benzenetetracarboxylic dianhydride (pyromellitic dianhydride (PMDA; CAS Reg. No. 89-32-7)) and 1,3-butadiene, homopolymer, hydroxy-terminated (PBD; CAS Reg. No. 69102-90-5) used in conjunction with cobalt stearate (CAS Reg. No. 13586-84-0) |
September 19, 2018 |
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Dimethyl, methyl vinyl polysiloxane, vinyl group-terminated (CAS Reg. No. 68083-18-1), reaction products with poly(ethylene-co-methyl acrylate) (CAS Reg. No. 25103-74-6) |
August 23, 2018 |
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2-hydroxyethyl methacrylate (HEMA; CAS Reg. No. 868-77-9) |
August 8, 2018 |
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Polycyclooctene (CAS Reg. No. 25267-51-0), used in conjunction with cobalt stearate (CAS Reg. No. 13586-84-0) |
September 20, 2018 |
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An aqueous mixture of peroxyacetic acid (CAS Reg. No.79-21- 0), hydrogen peroxide (CAS Reg. No.7722-84-1), acetic acid (CAS Reg. No. 64-19-17), 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP; CAS Reg. No. 2809-21-4), and optionally sulfuric acid (CAS Reg. No. 7664-93-9) |
August 30, 2018 |
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An aqueous mixture containing peroxyacetic acid (PAA; CAS Reg. No. 79-21-0), hydrogen peroxide (HP; CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP; CAS Reg. No. 2809-21-4), dipicolinic acid (DPA; CAS Reg. No. 499-83-2), and, optionally, sulfuric acid (CAS Reg. No. 7664-93-9) |
September 27, 2018 |
Click here for going to the Inventory of Effective Food Contact Substance (FCS) Notifications list.
US - California
Maximum Allowable Dose Levels (MADLs) for n-hexane On 5th October 2018, California’s Office of Environmental Health Hazard Assessment (OEHHA) opened a public consultation regarding its proposal to stablish two Maximum Allowable Dose Levels (MADLs) for n-hexane. The proposed MADLs are:
Consultation is opened until November 19, 2018. Click here for more information in OEHHA website. |
China
NHC published new notice regarding 14 new approved food contact additives and other relevant updates
On 30th September 2018, National Health Commission of the People’s Republic of China (NHC) adopted the safety evaluation of some new additives and monomers from China National Centre for Food Safety Risk Assessment (CFSA), and published notice No. 11 of 2018 based on Food Safety Law. This updated rule came into effect on the date of publication.
An overview of the new approved substances can be found as follows:
- Two new food contact additives are allowed to be used as additives for manufacturing food contact materials and articles
No. |
CAS# |
Substance |
1 |
1659307-53-5 |
1-Propannaminium, N,N,N-trimethyl-3-[(1-oxo-2-propen-1-yl)amino]-, chloride (1:1), polymer with ethenamine and 2-propenamide, hydrochloride |
2 |
8016-11-3 |
Epoxidized linseed oil |
- Seven food contact additives are expanded in terms of scope and usage
No. |
CAS# |
Substance |
3 |
9002-88-4 |
Polyethylene |
4 |
11097-59-9; 12304-65-3 |
Magnesium aluminium hydroxide carbonate (hydrate) |
5 |
123-95-5 |
Butyl stearate |
6 |
123-31-9 |
1,4-Benzenediol |
7 |
68611-44-9 |
Silane, dichlorodimethyl-, reaction products with silica |
8 |
110553-27-0 |
2-Methyl-4,6-bis(octylsulfanylmethyl)phenol |
9 |
6408-72-6 |
C.I. Disperse Violet 26; Disperse Violet H-FRL; 1,4-diamino-2,3-diphenoxyanthraquinone |
- Five new resins are allowed to be used as food contact resins
No. |
CAS# |
Substance |
10 |
68954-38-1 |
Formaldehyde reaction products with bisphenol A and butyl alcohol |
11 |
- |
2-propenoic acid, 2-methyl-, polymer with 1,4-benzenediol, 2-(chloromethyl) oxirane, 2-propenoic acid, 2-methyl-, ethyl ester, ethyl 2-propenoate, 2-propenoic acid, butyl ester and 4,4’-methylenebis [2,6-dimethylphenol], 2-(dimethylamino) ethanol-quarternized |
12 |
25034-86-0 |
2-Propenoic acid, 2-methyl-, methyl ester, polymer with ethenylbenzene |
13 |
- |
Urea polymer with formaldehyde and bisphenol A |
14 |
25214-81-7 |
Polymer of isophthalic acid, terephthalic acid, sebacic acid and butane-1,4-diol |
The complete notification can be found here (in Chinese).
China
MNHC public consultation regarding food contact materials and articles standards On 14th September 2018, China National Health Commission (NHC) launched a public consultation on two national food contact safety standards regarding surface coatings and paints (GB 4806.10) and regarding rubber material and articles (GB 4806.11). The public consultation was opened until 31st October 2018. The complete notification can be found here (in Chinese). |
Mercosur
Positive list for additives in plastic materials
On 14th September 2018, the MERCOSUR working subgroup nº 3 ("Technical regulations and conformity assessment") notified to the World Trade Organization the “Draft Common Market Group Resolution: "MERCOSUR Technical Regulation on the positive list of additives for the preparation of plastic materials and polymeric coatings in contact with foodstuffs" with reference G/TBT/N/ARG/343.
This draft establishes a list of authorized additives and the respective compositional limits, specific migration limits, usage restrictions, calculation method and the use of correction factors.
Final date for comments is 4th November 2018.