Eurofins | Newsflash - March 2019 | Food Contact Materials
Public consultation about Evaluation of Food Contact Materials (FCM)
On 11th February 2019, the European Commission opened the Online Public Consultation: Evaluation of Food Contact Materials to compile views, opinions and evidences on the functioning of Regulation (EC) No 1935/2004 (Food Contact Materials legislation).
Update draft of Single-Use Plastics Directive
On 18th January 2019, the Council of the European Union published an amendment (5483/19 ) of the draft Directive on the reduction of the impact of certain plastics products on the environment (Single-Use Plastics Directive).
Plastic additives initiative is a joint project of the European Chemicals Agency (ECHA) and industry launched in 2016. The aim of this project is to “characterize the uses of plastic additives and the extent to which the additives may be released from plastic articles”.
The project has lasted two years (2016-2018) and, as a result, an overview of over 400 additives in plastics used in high volumes in the EU has been generated. The project included the development of a method for comparing the release potential of the different additives. This method could be used by companies in order to check if registration dossiers should be updated or if improvement should be made on the communication of safe use information down the supply chain.
Click here to access the ECHA’s Mapping exercise – Plastic additives initiative.
Click here to get Supplementary Information on Scope and Methods by ECHA.
EFSA’s open repository to share scientific data
The European Food Safety Authority (EFSA) has recently published a report explaining how EFSA will be sharing scientific data, with open access, used for EU-wide monitoring programs and surveys, and for many of the EFSA risk assessments.
Click here for more information from EFSA’s supporting publications- Technical Report “Publication of scientific data from EU-coordinated monitoring programmes and surveys”.
Proposal to update requirements for rubber in contact with food and pacifiers
On 12th February 2019, France notified the European Commission its proposal “Order on rubber materials and articles intended to come into contact with food and pacifiers for infants and young children”, under Notification number 2019/57/F.
According to the Notification details: “This Order is intended to replace the Order of 9 November 1994. It updates components authorised for rubber materials and articles intended to come into contact with food and rubber dummies for infants and young children and the restrictions and specifications applicable to these components, taking into account developments in scientific knowledge and the relevant regulatory provisions adopted since 1994”.
Within the notified draft text, the following updates have been included:
- Update of authorised components list and their corresponding restrictions and specifications
- Modification of methods for verifying conformity of rubber materials and objects
- Description of obligations concerning technical documentation and provide a model for the declaration of conformity
Study to ban organic fluorinated compounds in food contact materials
On 6th February 2019, the Danish Ministry of Environment and Food published an article explaining that Denmark is considering to ban the use of organic fluorinated substances in cardboard and paper food contact materials.
The Minister asked the Danish Veterinary and Food Administration to examine the possibilities of a national ban on the use of the entire group of organic fluorine compounds in cardboard and paper food packaging because they are highly degradable and several of the substances are suspected to be endocrine disrupters.
In December 2018, the European Food Safety Authority (EFSA) published a new risk assessment of the two fluorinated substances PFOS and PFOA. EFSA's conclusion was that for both compounds, humans can tolerate far less than previously thought before there is a risk of adverse effects, hence proposing to revise the tolerable intakes of these two chemicals.
Denmark is considering, then, to implement this national ban until the EU further regulates on these substances in food contact materials.
New substances added to 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).
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FCN number |
Substances |
Date |
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N,N,N',N',-tetrakis(2-hydroxyethyl)hexanediamide (CAS Reg. No. 6334-25-4). |
Jan 9, 2019 |
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Copolymer of vinyl acetate (CAS Reg No. 108-05-4), butyl acrylate (CAS Reg No 141-32-2), glycidyl methacrylate (CAS Reg. No. 106-91-2), itaconic acid (CAS Reg. No. 97-65-4), and sodium vinylsulfonate (CAS Reg. No. 3039-83-6). |
Dec 26, 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). |
Dec 26, 2018 |
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Isononanoic and 2-ethylhexanoic acid esters with pentaerythritol |
Dec 21, 2018 |
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Isononanoic acid esters with dipentaerythritol |
Dec 21, 2018 |
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Fatty acids, C18-unsatd., dimers, polymers with caprolactam and hexamethylenediamine [Nylon 6/6.36] (CAS Reg. No 2068097-08-3). |
Dec 5, 2018 |
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(3R,6R)-3,6-dimethyl-1,4-dioxane-2,5-dione, polymer with rel-(3R,6S)-3,6-dimethyl-1,4-dioxane-2,5-dione and (3S,6S)-3,6-dimethyl-1,4-dioxane-2,5-dione (aka polylactide (PLA) polymers), optionally containing up to 16 weight percent D‐lactic acid polymer units (CAS Reg. No. 9051-89-2). |
Nov 30, 2018 |
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2-Propen-1-aminium, N,N-dimethyl-N-2-propen-1-yl-, chloride (1:1), polymer with ethanedial and 2-propenamide (CAS Reg. No. 32555-39-8). |
Jan 23, 2019 |
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A mixture of benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-[[4-[bis(2- hydroxyethyl)amino]-6-(phenylamino)-1,3,5-triazin-2-yl]amino]-, disodium salt (CAS Reg. No. 17958-73-5), benzenesulfonic acid, 5-[[4-[bis(2-hydroxyethyl)amino]-6-(phenylamino)-1,3,5-triazin-2-yl]amino]-2-[2-[4-[[4-[(2-hydroxyethyl)amino]-6-(phenylamino)-1,3,5-triazin-2-yl]amino]-2-sulfophenyl]ethenyl]-, disodium salt (CAS Reg. No. 88358-71-8) and Benzenesulfonic acid,2,2'-(1,2-ethenediyl)bis[5-[[4-[(2-hydroxyethyl)amino]-6-(phenylamino)-1,3,5-triazin-2-yl]amino]-, disodium salt (CAS Reg. No. 4193-55-9). |
Nov 9, 2018 |
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Polyurethane resin produced by reacting hexamethylene diisocyanate homopolymer (CAS Reg. No. 28182-81-2) with castor oil (CAS Reg. No. 8001-79-4). |
Nov 6, 2018 |
Click here for going to the Inventory of Effective Food Contact Substance (FCS) Notifications list.
Regulatory updates
Below a summary table with some recent regulation proposals notified to World Trade Organization:
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Notification number |
Countries |
Title |
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Brazil |
Draft Resolution 599, 22 January 2019
This draft resolution establishes the positive additive list intended to elaboration of plastic materials and polymeric coatings in contact with food among other measures.
It changes: - item 7b of Annex from Resolution- RES Num. 105, of 19 May 1999; - table of item 3.2 of Annex from Resolution- RDC Num. 52, of 26 November 2010; - item 4 of Annex from Resolution- RDC Num.56, of 16 November 2012.
It revokes Resolution- RDC Num. 17, of 17 March 2008 regarding positive additive list for plastic materials of packaging and equipment in contact with food. |
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Thailand |
Draft Thai Industrial Standard for Melamine-formaldehyde, Urea-formaldehyde and Melamine-urea- formaldehyde Utensils for Food: Safety Requirements (TIS 2921 - 25XX(20XX)) |
