Eurofins | August 2019 regulatory Newsflash compilation | Food Contact Materials
Safety assessment of titanium dioxide for food contact materials
On 26th June 2019, the European Food Safety Authority (EFSA) published the scientific opinion: “Safety assessment of the substance, titanium dioxide surface treated with fluoride‐modified alumina, for use in food contact materials”.
The Panel concluded that the substance does not raise safety concern for the consumer if used as an additive up to 25% w/w in polymers in contact with all food types for any time and temperature conditions. However, uses in polar polymers should be limited. The Panel emphasizes that the existing specific migration limits for aluminium and fluoride should not be exceeded in any case.
Click here for getting the safety assessment by EFSA.
Upcoming workshop on Evaluation of Food Contact Materials Legislation
On 9th September 2019, the European Commission will hold the “Stakeholder Workshop on the Evaluation of Food Contact Material Legislation – Discussion of Preliminary Findings” in Brussels.
The aim is to evaluate the current EU legislation on food contact materials and to see if it is fit for purpose and adequate.
Are Bamboo-melamine articles sustainable, recyclable and natural?
On 27th June 2019, the European Commission’s Expert Working Group on Food Contact Materials published a report regarding plastic food contact materials and articles containing ground bamboo or other similar constituents.
According to this report: “investigations also established that a number of these bamboo-melamine food contact materials and articles placed on the market are sold on the premise of being sustainable, recyclable and natural. They are labelled and marketed as ‘biodegradable’, 'eco-friendly', ‘organic’ or ‘natural’ or even in some cases ‘100% bamboo’, which does not reflect the true nature of the product. In many cases their trade name and description is used in support of that marketing approach and they are not readily identified as consisting of plastic. The Working Group notes that Article 3(2) of Regulation (EC) No 1935/20042 requires that ‘the labelling, advertising and presentation of a material or article shall not mislead consumers’.
Beyond misleading advertising, the report also emphasizes that only authorized substances should be used in plastic layers.
Click here for getting the report.
More Transparency in the Risk Assessments in the Food Chain
On 13th June 2019, the European Commission published a fact sheet regarding new legislation on transparency and sustainability of the EU risk assessment model in the food chain which was adopted by the European Parliament.
The aim is to increase the transparency of risk assessments in the food chain in the EU and to strengthen the reliability, objectivity, and independence of the studies used by the European Food Safety Authority (EFSA).
Public consultation: “Threshold of regulation for substances used in food-contact articles”
On 21st June 2019, the US Food and Drug Administration opened a public consultation on the approval request of “Threshold of Regulation for Substances Used in Food-Contact Articles” (21 CFR 170.39). It is possible to send comments until 20th August.
Click here for more information.
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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Copolymers of acrylamide, 2-(dimethylamino)ethyl methacrylate, itaconic acid, benzyl[2-(methacryloyloxy)ethyl](dimethyl)ammonium chloride, and benzyldimethyl[2-[(1-oxoallyl)oxy]ethyl]ammonium chloride, optionally crosslinked with hexahydro-1,3,5-tris(1-oxoallyl)-1,3,5-triazine |
May 31, 2019 |
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Oxirane, 2-methyl-, polymer with oxirane, ether with 1,2,3-propanetriol (3:1), polymer with 1,3-diisocyanato-2-methylbenzene and 2,4-diisocyanato-1-methylbenzene (CAS Reg. No. 68227-13-4) |
May 31, 2019 |
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An aqueous mixture of 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), and 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP; CAS Reg. No. 2809-21-4) |
May 28, 2019 |
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2,2‐bis((pentanoyloxy)methyl)propane‐1,3‐diyl dipentanoate (CAS Reg. No. 15834‐04‐5) |
May 28, 2019 |
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1,4-Benzenedicarboxylic acid, polymer with 2-methyl-1,8-octanediamine and 1,9-nonanediamine, reaction products with benzoic acid (CAS Reg. No. 1310362-57-2) |
May 28, 2019 |
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Aluminum silicon silver oxide with sodium zeolite Y (CAS Re. No. 308081-05-2) |
May 28, 2019 |
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Fatty acids, C14-C20, esters with pentaerythritol (CAS Reg. No. 68440-28-8) |
May 28, 2019 |
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Amines, hydrogenated tallow alkyl, acetates (CAS Reg. No. 61790-59-8) |
May 28, 2019 |
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Nylon MXD-6 (CAS Reg. No. 25718-70-1) (also known as hexanedioic acid, polymer with 1,3-benzenedimethanamine) meeting the analytical specifications in 21 CFR 177.1500(b) item 10.1 and used in conjunction with cobalt neodecanoate (CAS Reg. No. 27253-31-2) and/or cobalt propionate (CAS Reg. No. 1560-69-6) |
May 28, 2019 |
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An aqueous mixture of 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-hydroxyethylidine-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), and optionally sulfuric acid (CAS Reg. No. 7664-93-9) and/or dipicolinic acid (DPA) (CAS Reg. No. 499-83-2) |
May 20, 2019 |
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Butanedioic acid, 2-methylene-, polymer with ethenyl acetate, hydrolyzed, sodium salts (CAS Reg. No. 122625-12-1) |
May 19, 2019 |
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2-propenoic acid, polymer with sodium phosphinate (1:1), neutralized with sodium, calcium, and/or magnesium (including CAS Reg. No. 129898-01-7 (Na salt), CAS Reg. No. 935545-65-6 (Mg Na salt)) |
May 13, 2019 |
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2-propenoic acid, polymer with sodium phosphinate (1:1), neutralized with sodium, calcium, and/or magnesium (including CAS Reg. No. 129898-01-7 (Na salt), CAS Reg. No. 935545-65-6 (Mg Na salt)) |
May 13, 2019 |
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Trimethylolpropane (CAS Reg. No. 77-99-6) |
May 5, 2019 |
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1,4-benzenedicarboxylic acid, 1,4-dibutyl ester (CAS Reg. No. 1962-75-0) |
Apr 19, 2019 |
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Polyphenylene sulfide (CAS Reg. No. 26125-40-6 or 25212-74-2). REPLACES FCN 1731 |
Apr 14, 2019 |
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Acrylic resins derived from styrene (CAS Reg. No. 100-42-5), ethyl acrylate (CAS Reg. No. 140-88-5), 1,4-butanediol dimethacrylate (CAS Reg. No. 2082-81-7), acrylic acid (CAS Reg. No. 79-10-7), and 2-hydroxyethyl methacrylate (CAS Reg. No. 868-77-9) |
May 25, 2019 |
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An aqueous mixture of peroxylactic acid (PLA), hydrogen peroxide (HP), lactic acid, water, optional 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP), optionally sulfuric acid, and optionally phosphoric acid |
May 28, 2019 |
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Alcohols, C10-14-branched, C11-rich, reaction products with ethylene oxide, [(2-propenyloxy)methyl]oxirane and sulfamic acid (CAS Reg. No. 905843-50-7). The FCS is comprised primarily of poly(oxy-1,2-ethanediyl), α-sulfo-ω-[1-(hydroxymethyl)-2-(2-propen-1-yloxy)ethoxy]-, C11-rich, C10-14-branched alkyl ethers, ammonium salts (CAS Reg. No. 403983-53-9) |
May 5, 2019 |
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Alcohols, C10-14 branched, C11 rich, reaction products with polyethylene glycol and 2-[(2-propen-1-yloxy)methyl]oxirane (CAS Reg. No. 403983-11-9 and 1000866-04-5) |
May 5, 2019 |
Action plan to reduce plastic pollution
On 10th June 2019, the Government of Canada published news about the development of an action plan to implement the Canada-wide Strategy on Zero Plastic Waste. The Canadian Council of Ministers of the Environment is the authority in charge of this development.
The Government of Canada is taking the following steps to reduce plastic pollution:
- Banning harmful single-use plastics as early as 2021 under the Canadian Environmental Protection Act and taking other steps to reduce plastic waste, where supported by scientific evidence and when warranted – and taking other steps to reduce plastic waste
- Ensuring that companies that manufacture plastic products or sell items with plastic packaging are responsible for managing the collection and recycling of their plastic waste
- Working with industry to prevent and retrieve abandoned, lost, or discarded fishing gear, known as ghost fishing gear – a major contributor to marine plastic debris
- Investing in new Canadian technologies
- Mobilizing international support to address plastic pollution
- Reducing plastic waste from federal operations
- Reducing plastic microbeads in freshwater marine ecosystems
- Supporting community-led action and citizen-science activities
- Launching Canada’s Plastics Science Agenda
Click here for getting the news from Government of Canada’s website.
The new Food Safety and Standards Regulation has already entered into force
As already announced in our Eurofins News Flash February 2019 edition, in January 2019, the Food Safety and Standards Authority of India (FSSAI) notified the new Food Safety and Standards (Packaging) Regulations, 2018.
This new regulation came into force on 1st July 2019.
The new regulations include both general and specific requirements for packaging materials and also specify that food packaging materials must now comply with Indian Standards (IS). Previously, compliance with the standards was voluntary.
Click here for getting the FASSI’s press release.
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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Japan |
Amendment to the Cabinet Order and Ordinance for Enforcement of the Food Sanitation Act
Improvement of sanitary regulations for utensils, containers and packaging for food and food additives considering international consistency |
